Tocotrienol-rich vitamin E from palm oil (Tocovid) and its effects in diabetes and diabetic retinopathy: a pilot phase II clinical trial

Aim: To identify the effects of tocotrienol-rich vitamin E from palm oil (Tocovid) on diabetic retinopathy (DR) in patients with type 2 diabetes. Materials and methods: The intervention group (n = 21) received 200 mg Tocovid twice daily while the control group (n = 22) received placebo twice daily for 8 weeks. Changes in retinal photography by conventional grading and novel quantification of retinal hemorrhage were assessed. Changes in serum biomarkers advanced glycation end products (AGE) general, sRAGE (soluble receptor of AGE), Nε-CML (specific type of AGE), and cystatin C were evaluated. Results: A novel technique to quantify retinal hemorrhage had a strong positive correlation with conventional grading of DR in both eyes at baseline and at the end of the study. Eight-week supplementation of Tocovid resulted in significant reduction in retinal hemorrhage in the right eye. Liver enzymes and ALT significantly reduced. No significant changes in grade of DR, serum biomarkers, HbA1c, blood pressure, renal profile, and lipid profile were observed. Conclusions: Tocovid is a potential adjunct to current treatment of DR and fatty liver disease. A novel method of quantifying retinal hemorrhage is a potential technique for assessing disease severity of DR, particularly the early changes.

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Tocotrienol-Rich Vitamin E from Palm Oil (Tocovid) and Its Effects in Diabetes and Diabetic Nephropathy: A Pilot Phase II Clinical Trial

Nutrients ◽

10.3390/nu10091315 ◽

2018 ◽

Vol 10 (9) ◽

pp. 1315 ◽

Cited By ~ 7

Author(s):

Suzanne Tan ◽

Yilynn Chiew ◽

Badariah Ahmad ◽

Khalid Kadir

Keyword(s):

Blood Pressure ◽

Diabetic Nephropathy ◽

Vitamin E ◽

Serum Creatinine ◽

Palm Oil ◽

Controlled Trial ◽

Intervention Group ◽

Serum Biomarkers ◽

Control Group ◽

Potential Biomarker

Tocotrienol-rich vitamin E from palm oil (Tocovid) has been shown to ameliorate diabetes through its superior antioxidant, antihyperglycemic, and anti-inflammatory properties in diabetic rats. This study aimed to investigate the effects of Tocovid on diabetic nephropathy in patients with type 2 diabetes. Baseline parameters of potential subjects such as HbA1c, blood pressure, Advanced Glycation Endproduct (AGE), soluble receptor for AGE (sRAGE), Nε-Carboxymethyllysine (Nε-CML), and Cystatin C were assessed for possible correlation with diabetic nephropathy. Only subjects with diabetic nephropathy or urine microalbuminuria-positive defined as Urine Albumin to Creatinine Ratio (UACR) >10 mg/mmol were recruited into a prospective, randomized, double-blinded, placebo-controlled trial. The intervention group (n = 22) received Tocovid 200 mg twice a day while the control group (n = 23) received placebo twice a day for 8 weeks. Changes in Hemoglobin A1c (HbA1c), blood pressure, serum biomarkers and renal parameters such as UACR, serum creatinine, and estimated Glomerular Filtration Rate (eGFR) were compared between the two groups. It was found that serum Nε-CML significantly correlated to the severity of microalbuminuria. For every 1 ng/mL increase in serum Nε-CML, the odds of diabetic nephropathy increased by 1.476 times. Tocovid, compared to placebo, significantly reduced serum creatinine but not eGFR, UACR, HbA1c, blood pressure, and serum biomarkers. In conclusion, serum Nε-CML is a potential biomarker for diabetic nephropathy. Treatment with Tocovid significantly reduced serum creatinine; therefore Tocovid may be a useful addition to the current treatment for diabetic nephropathy.

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The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial

Nutrients ◽

10.3390/nu12051522 ◽

2020 ◽

Vol 12 (5) ◽

pp. 1522

Author(s):

Yeek Tat Ng ◽

Sonia Chew Wen Phang ◽

Gerald Chen Jie Tan ◽

En Yng Ng ◽

Nevein Philip Botross Henien ◽

...

Keyword(s):

Vitamin E ◽

Nerve Conduction ◽

Controlled Trial ◽

Intervention Group ◽

Serum Biomarkers ◽

Control Group ◽

Controlled Clinical Trial ◽

Diabetic Patients ◽

Chronic Hyperglycemia ◽

Conduction Velocities

Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group (n = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group (n = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35, p < 0.001, median nerve; +1.60 m/s, IQR 1.80, p < 0.001, sural nerve; +0.75 m/s, IQR 2.25, p < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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Efficacy of calcium dobesilate in treating Chinese patients with mild-to-moderate non-proliferative diabetic retinopathy (CALM-DR): protocol for a single-blind, multicentre, 24-armed cluster-randomised, controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-045256 ◽

2021 ◽

Vol 11 (5) ◽

pp. e045256

Author(s):

Hao Hu ◽

Jiang Liu ◽

Duolao Wang ◽

Shanhu Qiu ◽

Yang Yuan ◽

...

Keyword(s):

Diabetic Retinopathy ◽

Conventional Treatment ◽

Intervention Group ◽

Chinese Patients ◽

Ethical Review ◽

Control Group ◽

Calcium Dobesilate ◽

Cluster Randomised ◽

Randomised Controlled ◽

Single Blind

IntroductionCalcium dobesilate (CaD) has been used in the treatment of diabetic retinopathy (DR) due to its potential in protecting against retinal vascular damage. However, there is limited evidence exploring its efficacy in combating DR progression. This study is aimed at evaluating whether CaD could prevent DR progression into an advanced stage among Chinese patients with mild-to-moderate non-proliferative DR (NPDR).Methods and analysisThis study is a single-blind, multicentre, cluster-randomised, controlled superiority trial. A total of 1272 patients with mild-to-moderate NPDR will be enrolled and randomly assigned at a 1:1 ratio into the control group (conventional treatment group) and the intervention group (conventional treatment plus CaD (500 mg three times per day) for 12 months). Patients will be followed at 1, 3, 6 and 12 months after randomisation and receiving treatments, with the severity of DR assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. The primary endpoint is the progression of DR during follow-up, which is defined as an increase of two or more steps in the ETDRS scale. The secondary endpoints include the concomitant changes in visual acuity, presence, number, location and type of retinal lesions, and retinal blood vessel diameter as well as the arteriovenous ratio at different visits.Ethics and disseminationEach local ethics committee (first Vote: Ethical Review Committees of Zhongda Hospital of Southeast University (2019ZDSYLL132-P01)) has approved the study. The results will be published in high impact peer-reviewed scientific journals aimed at the general reader.Trial registration numbersNCT04283162.

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Association between risk factors and retinal nerve fiber layer loss in early stages of diabetic retinopathy

International Journal of Ophthalmology ◽

10.18240/ijo.2021.02.12 ◽

2021 ◽

Vol 14 (2) ◽

pp. 255-262

Author(s):

Zhong-Qi Wan ◽

◽

Min Cui ◽

Yong-Jie Zhang ◽

◽

...

Keyword(s):

Risk Factors ◽

Diabetic Retinopathy ◽

Nerve Fiber ◽

Systolic Pressure ◽

Control Group ◽

Diabetic Patients ◽

Fiber Layer ◽

Rnfl Thickness ◽

Normal Individuals ◽

The Right

AIM: To investigate the changes of retinal nerve fiber layer (RNFL) among normal individuals, diabetic patients without diabetic retinopathy (NDR) and non-proliferative diabetic retinopathy (NPDR), and explore the possible risk factors of early diabetic retinopathy (DR). METHODS: In this cross-sectional study, 107 participants were divided in three groups. Totally 31 normal individuals (control group), 40 diabetic patients without DR (NDR group) and 36 patients with NPDR (NPDR group) were included. Optical coherence tomography (OCT) was used to detect RNFL thickness and other optic disc parameters among different groups. The potential association between RNFL loss and systemic risk factors were assessed for DR, including diabetes duration, body mass index (BMI), hemoglobin A1c (HbA1c), serum lipids, and blood pressure. RESULTS: The average and each quadrant RNFL thickness were thinner in NPDR group compared to control group of the right (P=0.00, P=0.01, P=0.01, P=0.02, P=0.04) and left eyes (P=0.00, P=0.00, P=0.00, P=0.03, P=0.04). The average, superior and inferior RNFL thickness were thinner in NDR group compared to the NPDR group of the right (P=0.00, P=0.02, P=0.03) and left eyes (P=0.00, P=0.00, P=0.01). Diabetic duration was negatively correlated with the superior, inferior, and average RNFL thickness of the right (r=-0.385, P=0.001; r=-0.366, P=0.001; r=-0.503, P=0.000) and left eyes (r=-0.271, P=0.018; r=0.278, P=0.015; r=-0.260, P=0.023). HbA1c was negatively correlated with the superior, inferior, and average RNFL thickness of the right (r=-0.316 P=0.005; r=-0.414, P=0.000; r=-0.418, P=0.000) and left eyes (r= -0.367, P=0.001; r=-0.250, P=0.030; r=-0.393, P=0.000). Systolic pressure was negatively correlated with the inferior and average RNFL thickness of the right eye (r=-0.402, P=0.000; r=-0.371, P=0.001) and was negatively correlated with the superior and average RNFL thickness of the left eye (r=-0.264, P=0.021; r=-0.233, P=0.043). CONCLUSION: RNFL loss, especially in the superior and inferior quadrants, may be the earliest structural change of the retina in diabetic patients, and is also associated with diabetic duration, HbA1c, and systolic pressure.

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Health education improves referral compliance of persons with probable Diabetic Retinopathy: A randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0242047 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0242047

Author(s):

Zara Khair ◽

Md Moshiur Rahman ◽

Kana Kazawa ◽

Yasmin Jahan ◽

Abu S. G. Faruque ◽

...

Keyword(s):

Type 2 Diabetes ◽

Diabetic Retinopathy ◽

Health Education ◽

Controlled Trial ◽

Compliance Rate ◽

Intervention Group ◽

Multivariate Logistic Regression Model ◽

Control Group ◽

Referral Compliance

Objective Lack of awareness about Diabetic Retinopathy (DR) is the most commonly cited reason why many persons with type 2 diabetes are non-compliant with referral instruction to undergo retinal screening. The purpose of this study was to evaluate the efficacy of a culturally, geographically and socially appropriate, locally adapted five-month-long health education on referral compliance of participants. Method A prospective randomized, open-label parallel group study was conducted on persons with type 2 diabetes who underwent basic eye screening at a diabetes hospital between September 2017 and August 2018. Participants who were noncompliant with referral instruction to visit a hospital for advanced DR management were randomly divided into health education intervention group (n = 143) and control group (n = 156). Both groups received information regarding DR and referral instruction at the diabetes hospital. The intervention group was provided personalized education followed by telephonic reminders. The primary endpoint was ‘increase in referral compliance’ and the secondary endpoint was ‘increase in knowledge of DR’. Multivariate logistic regression model was used to identify significant predictors of compliance to referral. Results A total of nine participants dropped and 290 completed the post intervention survey. The compliance rate in intervention group was found to be significantly higher than the control group (64.3% vs 28.2%; OR 4.73; 95% CI 2.87–7.79; p<0.001). Participants in the intervention group acquired better knowledge on DR (p<0.05). Apart from intervention, referral compliance rate was also found to be significantly associated with participants’ self-perception of vision problem (OR 2.02; 95% CI 1.02–4.01; p = 0.045) and participants’ income (OR 1.24; 95% CI 1.06–1.44; p = 0.008). Discussion Our results suggest that intensive health education on DR should be integrated with diabetes education as it may result in significantly improved referral compliance. Outcomes may be sustainable if interventions are institutionalized at referral point. Trial registration Clinical Trials.gov (Registration # NCT03658980); https://clinicaltrials.gov/ct2/show/NCT03658980.

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α-Tocopherol in breast milk of women with preterm delivery after a single postpartum oral dose of vitamin E

British Journal Of Nutrition ◽

10.1017/s0007114516000477 ◽

2016 ◽

Vol 115 (8) ◽

pp. 1424-1430 ◽

Cited By ~ 8

Author(s):

Jeane Franco Pires Medeiros ◽

Karla Danielly da Silva Ribeiro ◽

Mayara Santa Rosa Lima ◽

Renata Alexandra Moreira das Neves ◽

Amanda Cibely Pinheiro Lima ◽

...

Keyword(s):

Vitamin E ◽

Breast Milk ◽

Controlled Trial ◽

Intervention Group ◽

Relevant Information ◽

Maternal Serum ◽

Tocopheryl Acetate ◽

Control Group ◽

Mature Milk ◽

Tocopherol Concentration

AbstractWe evaluated the effect of maternal vitamin E supplementation on the α-tocopherol concentrations of colostrum, transitional milk and mature milk of women who had given birth prematurely. This longitudinal randomised-controlled trial divided eighty-nine women into two groups: a control group and a supplemented group. Blood and breast milk were collected from all the participants after delivery. Next, each woman in the supplemented group received 400 IU of RRR-α-tocopheryl acetate. Further breast milk samples were collected 24 h after the first collection, as well as 7 and 30 d after delivery. α-Tocopherol concentrations were determined by HPLC. The baseline α-tocopherol concentrations in the maternal serum of the two groups were similar: 1159·8 (sd 292·4) μg/dl (27·0 (SD 6·8) μmol/l) for the control group and 1128·3 (sd 407·2) μg/dl (26·2 (SD 9·5) μmol/l) for the supplemented group. None of the women was vitamin E deficient. Breast milk α-tocopherol concentrations increased by 60 % 24 h after supplementation in the intervention group and did not increase at all in the control group. α-Tocopherol concentration of the transitional milk in the supplemented group was 35 % higher compared with the control group. α-Tocopherol concentrations of the mature milk in both groups were similar. Maternal supplementation with 400 IU of RRR-α-tocopherol increased the vitamin E concentrations of the colostrum and transitional milk, but not of the mature milk. This study presents relevant information for the design of strategies to prevent and combat vitamin E deficiency in the risk group of preterm infants.

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Positive Association of Vitamin E Supplementation with Hemoglobin Levels in Mildly Anemic Healthy Pakistani Adults

International Journal for Vitamin and Nutrition Research ◽

10.1024/0300-9831/a000222 ◽

2015 ◽

Vol 85 (1-2) ◽

pp. 39-49 ◽

Cited By ~ 1

Author(s):

Tanveer Jilani ◽

Iqbal Azam ◽

Bushra Moiz ◽

Naseema Mehboobali ◽

Mohammad Perwaiz Iqbal

Keyword(s):

Vitamin E ◽

General Population ◽

Repeated Measures ◽

Venous Blood ◽

Plasma Concentrations ◽

Intervention Group ◽

Positive Association ◽

Total Antioxidant Status ◽

Control Group ◽

Vitamin E Supplementation

Abstract. Background: Hemoglobin levels slightly below the lower limit of normal are common in adults in the general population in developing countries. A few human studies have suggested the use of antioxidant vitamins in the correction of mild anemia. The objective of the present study was to investigate the association of vitamin E supplementation in mildly anemic healthy adults with post-supplemental blood hemoglobin levels in the general population of Karachi, Pakistan. Method: In a single-blinded and placebo-controlled randomized trial, 124 mildly anemic subjects from the General Practitioners’ Clinics and personnel of the Aga Khan University were randomized into intervention (n = 82) and control (n = 42) group. In the intervention group, each subject was given vitamin E (400 mg) everyday for a period of three months, while control group subjects received a placebo. Eighty six subjects completed the trial. Fasting venous blood was collected at baseline and after three months of supplementation. Hemoglobin levels and serum/plasma concentrations of vitamin E, vitamin B12, folate, ferritin, serum transferrin receptor (sTfR), glucose, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, creatinine, total-antioxidant-status and erythropoietin were measured and analyzed using repeated measures ANOVA and multiple linear regression. Results: The adjusted regression coefficients (β) and standard error [SE(β)] of the significant predictors of post-supplemental hemoglobin levels were serum concentration of vitamin E (0.983[0.095]), gender (- 0.656[0.244]), sTfR (- 0.06[0.02]) and baseline hemoglobin levels (0.768[0.077]). Conclusion: The study showed a positive association between vitamin E supplementation and enhanced hemoglobin levels in mildly anemic adults.

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Effect of an individualised high-protein, energy-restricted diet on anthropometric and cardio-metabolic parameters in overweight and obese Malaysian adults: a 6-month randomised controlled study

British Journal Of Nutrition ◽

10.1017/s0007114519000345 ◽

2019 ◽

Vol 121 (09) ◽

pp. 1002-1017 ◽

Cited By ~ 1

Author(s):

Soma Roy Mitra ◽

Pui Yee Tan

Keyword(s):

Vitamin E ◽

Intervention Group ◽

Diet Group ◽

Dietary Guidelines ◽

High Protein ◽

Metabolic Parameters ◽

Lower Percentage ◽

Controlled Study ◽

Control Group ◽

Protein Energy

AbstractThe aim of this study was to investigate the effectiveness of the Hipcref (high-protein, energy-restricted, high-vitamin E and high-fibre) diet in Malaysian adults on body composition and metabolic parameters after an intervention period of 6 months. Overweight/obese Malaysian adults (n128; BMI≥23 kg/m2) were randomised to the Hipcref (n65) or control diet (n63). The intervention group received Hipcref diet charts based on their personal preferences. The control group followed a generalised dietary advice based on Malaysian Dietary Guidelines, 2010. All participants were responsible for preparing their own meals. There was a significant treatment group×time effect on anthropometric parameters (P<0·05) on an intention-to-treat basis. Pairwise comparisons revealed that Hipcref diet participants had significant reduction in weight, BMI, waist circumference, fat mass and percentage body fat at months 3 and 6 compared with baseline (P<0·001). The control group had significant increase in weight and BMI at months 3 and 6 compared with baseline (P<0·05). The Hipcref diet group had higher reduction in fasting insulin, insulin resistance and C-reactive protein levels compared with the control group at month 6 (P<0·05). Post-intervention, compared with the control group, the Hipcref diet group was found to consume significantly higher percentage energy from protein, and PUFA, higher energy-adjusted vitamin E (mg) and fibre (g), and lower total energy, lower percentage energy from fat and carbohydrate (P<0·05). The success of the Hipcref diet on overweight/obese Malaysian adults may be due to the combined effect of the nutrient composition of the Hipcref diet.

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Increasing the Use of Hearing Protection Devices by Delegating the Right to the Workers

Archives of Occupational Health ◽

10.18502/aoh.v3i3.1285 ◽

2019 ◽

Author(s):

Faranak Mahdavi ◽

Mohammad Reza Monazzam ◽

Seyed Abolfazl Zakerian ◽

Mohsen Meshkani

Keyword(s):

Intervention Group ◽

Control Group ◽

Hearing Protection ◽

Full Time ◽

Sound Levels ◽

Protection Devices ◽

The Right ◽

Two Stages ◽

And Control ◽

Harmful Effects

Background: Noise-induced hearing loss (NIHL) is one of the most common but absolutely preventable occupational diseases. One of the measures to prevent and control noise's harmful effects in the workplaces is the use of hearing protection devices (HPDs) that workers do not often accept to use or do not use throughout the entire work shift. Therefore, the aim of this study is to investigate the effectiveness of delegating the right to choose HPD to workers on the increase of the duration of using them. Methods: This interventional study was conducted on 60 male workers divided into two groups, intervention (n: 30) and control (n: 30), who were exposed to non-permissible sound levels during sampling. A questionnaire including BASNEF constructs was completed by both groups in two stages, ie, before intervention and 3 months after completion of the intervention delegating the right to choose HPD to workers. Durations of using HPD were recorded in two stages in intervention and control groups and compared. Data analysis was conducted by SPSS 22. Results: In intervention group, the number of workers who used HPDs full time was 0 (0%) before intervention and 16 (53.33%) after intervention. The duration of using HPDs significantly increased after intervention in intervention group than in control group. Conclusion: The intervention based on providing HPDs that are appropriate for the needs and wishes of workers and available as well as promoting their use in the work environment can persuade them to use such devices continuously.

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