scholarly journals Thyroid Hormone Replacement for Central Hypothyroidism: A Randomized Controlled Trial Comparing Two Doses of Thyroxine (T4) with a Combination of T4 and Triiodothyronine

2007 ◽  
Vol 92 (11) ◽  
pp. 4115-4122 ◽  
Author(s):  
Marc Slawik ◽  
Björn Klawitter ◽  
Edith Meiser ◽  
Marcus Schories ◽  
Oliver Zwermann ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hormone Replacement ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Well Being ◽  
Double Blind ◽  
Central Hypothyroidism ◽  
Beneficial Effects ◽  
Serum T3 ◽  
Free Serum

Abstract Background: Dosage of T4 in central hypothyroidism is primarily guided by the free serum T4 level (fT4). However, the optimum fT4 range is ill defined, and subtle hypothyroidism might be missed using this approach. Objectives: Our aim was to investigate the effects of a body weight (bw)-adapted T4 treatment, alone or in combination with T3, on metabolism, well-being, and cognitive function in comparison to a regimen leading to normal fT4. Design: This was a placebo-controlled trial (double-blind, crossover). Patients: A total of 29 patients (age 52 ± 2 yr; females/males, 8/21) with hypopituitarism, including TSH deficiency, participated in the study. Interventions: Three regimens were compared (5 wk each): “EMPIRICAL-T4,” empirical T4 dosage (1 ± 0.05 μg/kg bw) leading to normal fT4; BW-ADAPTED-T4 (1.6 μg/kg bw T4); and “BW-ADAPTED-T3T4,” bw-adapted combination of T3 and T4 (ratio of 1:10). Results: BW-ADAPTED-T4 administration increased mean fT4 concentrations to the upper limit of the normal range (peak levels). Compared with EMPIRICAL-T4, BW-ADAPTED-T4 treatment resulted in a lower body mass index (BMI) (29.0 ± 0.7 vs. 29.5 ± 0.7 kg/m2; P < 0.03), lower total cholesterol (198 ± 9 vs. 226 ± 7 mg/dl; P < 0.01), and lower low-density lipoprotein (LDL) cholesterol (116 ± 5 vs. 135 ± 7 mg/dl; P < 0.01). BW-ADAPTED-T3T4 treatment was associated with additional beneficial effects on ankle reflex time and working memory but resulted in supraphysiological free serum T3 (fT3) levels. Limitations: Long-term side effects may have been missed. Conclusions: Using a dose of 1.6 μg/kg bw improved markers commonly associated with central hypothyroidism. This suggests that T4 dosage based on bw and aiming at fT4 in the upper reference range is superior to titration of T4 aiming at middle normal fT4 concentrations in those patients.

scholarly journals Vitamin D-Fortified Bread Is as Effective as Supplement in Improving Vitamin D Status: A Randomized Clinical Trial

2016 ◽  
Vol 101 (6) ◽  
pp. 2511-2519 ◽  
Author(s):  
Bahareh Nikooyeh ◽  
Tirang R. Neyestani ◽  
Maliheh Zahedirad ◽  
Mehrdad Mohammadi ◽  
S. Hedayat Hosseini ◽  
...  
Keyword(s):  
Vitamin D ◽  
Controlled Trial ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Cholesterol Concentration ◽  
Daily Consumption ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Group Reduction ◽  
25 Hydroxyvitamin D

Abstract Context: Bread can potentially be a suitable vehicle for fortification with vitamin D. Objective: This study was undertaken to evaluate the following: 1) the bioavailability of vitamin D from the fortified Iranian bread and 2) the possible effects of daily consumption of the fortified bread on certain health aspects. Design, Setting, and Participants: This was a randomized, double-blind, placebo-controlled trial conducted over 8 weeks in 90 healthy subjects aged 20–60 years. Intervention: Subjects were randomly allocated to one of three groups: 1) fortified bread (FP; 50 g bread fortified with 25 μg vitamin D3 plus placebo daily; n = 30); 2) supplement (SP; 50 g plain bread plus 25 μg vitamin D supplement daily; n = 30); and 3) control (CP; 50 g plain bread plus placebo daily; n = 30). Outcome Measures: Initial and final anthropometric and biochemical assessments were performed. Results: The within-group changes of serum 25-hydroxyvitamin D concentrations were 39.0 ± 22.6 (P < .001), 28.9 ± 31.2 (P < .001), and −9.2 ± 12.3 nmol/L in the FP, SP, and CP groups, respectively. Only in FP and SP groups, serum intact PTH concentrations decreased approximately 13.5% and 14.5%, respectively. Visceral fat also showed a significant decrement in FP (−1.05% ± 1.4%; P ≤ .001) and SP (−0.96% ± 1.7%; P = .006). Serum low-density lipoprotein cholesterol concentration showed a within-group reduction in FP (−10.4 ± 11.2 mg/dL; P < .001) and an insignificant decrement in SP (−6.6 ± 20.2 mg/dL; P = .083). Serum high-density lipoprotein increased in both vitamin D-supplemented groups (FP: 9.7 ± 7.6 vs SP: 5.7 ± 6.7 mg/dL; P < .001). Conclusion: Vitamin D-fortified bread could be potentially effective in raising circulating 25-hydroxyvitamin D levels of the population to nearly adequate levels.

scholarly journals Daily intake of heat-killed Lactobacillus plantarum L-137 improves inflammation and lipid metabolism in overweight healthy adults: a randomized-controlled trial

2019 ◽  
Vol 59 (6) ◽  
pp. 2641-2649 ◽  
Author(s):  
Yusuke Tanaka ◽  
Yoshitaka Hirose ◽  
Yoshihiro Yamamoto ◽  
Yasunobu Yoshikai ◽  
Shinji Murosaki
Keyword(s):  
Lipid Metabolism ◽  
Lactobacillus Plantarum ◽  
Mononuclear Cells ◽  
Controlled Trial ◽  
Low Density Lipoprotein ◽  
Daily Intake ◽  
Density Lipoprotein ◽  
Control Group ◽  
Double Blind ◽  
Peripheral Blood Mononuclear

Abstract Purpose The effects of heat-killed Lactobacillus plantarum L-137 (HK L-137) on inflammation and lipid metabolism were investigated in overweight volunteers. Methods One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4 years) were enrolled in this randomized, double-blind, placebo-controlled, parallel group study. Subjects were randomly assigned to daily administration of a tablet containing HK L-137 (10 mg) or a placebo tablet for 12 weeks. Blood samples were collected every 4 weeks to measure biomarkers of lipid metabolism and inflammatory mediators. Results The percent change of concanavalin A-induced proliferation of peripheral blood mononuclear cells was significantly larger in the HK L-137 group than in the control group, similar to previous studies. The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point. These effects of HK L-137 were stronger in the subjects with higher C-reactive protein levels. Conclusions These findings suggest that daily intake of HK L-137 can improve inflammation and lipid metabolism in subjects at risk of inflammation.

scholarly journals Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial

Homeopathy ◽  
2019 ◽  
Vol 108 (02) ◽  
pp. 102-107 ◽  
Author(s):  
Débora Andrade ◽  
Fabio Carmona ◽  
Mateus Angelucci ◽  
Edson Martinez ◽  
Ana Pereira
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Hormone Replacement ◽  
Hot Flashes ◽  
Well Being ◽  
Capsicum Frutescens ◽  
Phase 2 ◽  
Double Blind ◽  
Homeopathic Medicine ◽  
Menopausal Women

Background Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta. Methods This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group. Results The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008). Conclusion The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.

scholarly journals The Effect of Deydroepiandrosterone Supplementation to Symptomatic Perimenopausal Women on Serum Endocrine Profiles, Lipid Parameters, and Health-Related Quality of Life1

1999 ◽  
Vol 84 (11) ◽  
pp. 3896-3902 ◽  
Author(s):  
Kurt T. Barnhart ◽  
Ellen Freeman ◽  
Jeanne Anne Grisso ◽  
Daniel J. Rader ◽  
Mary Sammel ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Density Lipoprotein ◽  
Well Being ◽  
Scientific Data ◽  
Double Blind ◽  
Age Related ◽  
Perimenopausal Women ◽  
Related Quality ◽  
Endocrine Profile ◽  
Perimenopausal Symptoms

Dehydroepiandrosterone (DHEA), an androgenic steroid hormone, exhibits an age-related decline. Perimenopausal women have only approximately 50% of peak DHEA levels. Despite limited scientific data, DHEA has gained recognition as a dietary supplement to reduce the symptoms of aging and improve well-being. This randomized, double-blind placebo-controlled trial examined the effects of 50 mg/day of oral DHEA supplementation, for 3 months, on 60 perimenopausal women with complaints of altered mood and well-being. Changes in the serum endocrine profile of women in the DHEA group were significantly greater than the placebo group, including a 242% [95% confidence interval (CI) +60.1, +423.9] increase in DHEAS, a 94.8% (95% CI +34.2, +155.4) increase in testosterone, and a 13.2% (95% CI− 27.88, +0.5) decline in cortisol compared to baseline. Women receiving DHEA had a 10.1% (95% CI −15.0, −5.1) decline in high-density lipoprotein and an 18.1% (95% CI −32.2, −3.9) decline in Lp(a) from baseline, but these declines did not significantly differ from women who received placebo. Women receiving DHEA did not have any improvements significantly greater than placebo in the severity of perimenopausal symptoms, mood, dysphoria, libido, cognition, memory, or well-being. DHEA supplementation significantly effects the endocrine profile, may affect the lipid profile, but does not improve perimenopausal symptoms or well-being compared to placebo.

scholarly journals Physical Activity to Stay Fit

2020 ◽  
Author(s):  
Arkierupaia Shadap
Keyword(s):  
Physical Activity ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Well Being ◽  
World Health ◽  
Beneficial Effects ◽  
Bodily Movement ◽  
Wide Range ◽  
Healthy Body Weight ◽  
Health Organization

AbstractPhysical activity is any bodily movement produced by skeletal muscles that require energy expenditure. According to World Health Organization, regular physical activities such as walking, cycling, doing the household work, etc., make an individual feel good and it has significant benefits for health. One of the vital elements for healthy bones at every age is exercise. Exercise lowers the blood pressure, slightly decreases the levels of total- and low-density lipoprotein—the bad cholesterol, and increases the levels of high-density lipoprotein—the good cholesterol. Regular physical activity and exercise help in maintaining the healthy body weight, decreasing stress, apprehension, and preventing depression. Exercising can also possibly help in delaying the effects of Alzheimer’s disease and other forms of dementia. Strong evidence shows that physical activity has a wide range of beneficial effects for both physical and mental well-being.

scholarly journals Simvastatin add-on to escitalopram in patients with comorbid obesity and major depression (SIMCODE): study protocol of a multicentre, randomised, double-blind, placebo-controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040119
Author(s):  
Christian Otte ◽  
Woo Ri Chae ◽  
Jan Nowacki ◽  
Michael Kaczmarczyk ◽  
Dominique Piber ◽  
...  
Keyword(s):  
Rating Scale ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Low Density Lipoprotein ◽  
Antidepressant Medication ◽  
Density Lipoprotein ◽  
Federal State ◽  
Double Blind ◽  
Madrs Score ◽  
Randomised Controlled

IntroductionMajor depressive disorder (MDD) and obesity are both common disorders associated with significant burden of disease worldwide. Importantly, MDD and obesity often co-occur, with each disorder increasing the risk for developing the other by about 50%–60%. Statins are among the most prescribed medications with well-established safety and efficacy. Statins are recommended in primary prevention of cardiovascular disease, which has been linked to both MDD and obesity. Moreover, statins are promising candidates to treat MDD because a meta-analysis of pilot randomised controlled trials has found antidepressive effects of statins as adjunct therapy to antidepressants. However, no study so far has tested the antidepressive potential of statins in patients with MDD and comorbid obesity. Importantly, this is a difficult-to-treat population that often exhibits a chronic course of MDD and is more likely to be treatment resistant. Thus, in this confirmatory randomised controlled trial, we will determine whether add-on simvastatin to standard antidepressant medication with escitalopram is more efficacious than add-on placebo over 12 weeks in 160 patients with MDD and comorbid obesity.Methods and analysisThis is a protocol for a randomised, placebo-controlled, double-blind multicentre trial with parallel-group design (phase II). One hundred and sixty patients with MDD and comorbid obesity will be randomised 1:1 to simvastatin or placebo as add-on to standard antidepressant medication with escitalopram. The primary outcome is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to week 12. Secondary outcomes include MADRS response (defined as 50% MADRS score reduction from baseline), MADRS remission (defined as MADRS score <10), mean change in patients’ self-reported Beck Depression Inventory (BDI-II) and mean change in high-density lipoprotein, low-density lipoprotein and total cholesterol from baseline to week 12.Ethics and disseminationThis protocol has been approved by the ethics committee of the federal state of Berlin (Ethik-Kommission des Landes Berlin, reference: 19/0226—EK 11) and by the relevant federal authority (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), reference: 4043387). Study findings will be published in peer-reviewed journals and will be presented at (inter)national conferences.Trial registration numbersNCT04301271, DRKS00021119, EudraCT 2018-002947-27.

scholarly journals Effect of Psyllium Supplementation on Insulin Resistance and Lipid Profile in Non-diabetic Women With Polycystic Ovary Syndrome: A Randomized Placebo-Controlled Trial

2018 ◽  
Vol 8 (2) ◽  
pp. 184-191
Author(s):  
Fatemeh Pourbehi ◽  
Parvin Ayremlou ◽  
Alireza Mehdizadeh ◽  
Rasoul Zarrin
Keyword(s):  
Insulin Resistance ◽  
Polycystic Ovary Syndrome ◽  
Lipid Profile ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Fasting Insulin ◽  
Ovary Syndrome ◽  
Double Blind

Objectives: Polycystic ovary syndrome (PCOS) is the most common cause of infertility in women. In addition, the risk of type2 diabetes mellitus (T2DM), hyperinsulinemia, and insulin resistance is higher among women with PCOS. Psyllium can reduce the levels of fasting blood sugar (FBS), insulin resistance, and lipid profile. Thus, the present study aimed to evaluate the effect of psyllium supplementation on insulin resistance and the lipid profile in non-diabetic women with PCOS. Materials and Methods: In this randomized double-blind placebo-controlled trial, 54 eligible non-diabetic women with PCOS aged 18-45 were recruited from an endocrinology clinic and divided into 2 groups based on their body mass index (BMI) through stratified-block randomization. Participants in intervention and placebo groups received 5 g of psyllium or cellulose microcrystalline twice a day for 8 weeks. Fasting insulin, FBS, and insulin resistance indicators including HOMA1-IR, HOMA2-IR, along with quantitative insulin sensitivity check index (QUICKI) and the lipid profile were evaluated before and after the intervention. Results: In the psyllium group, the FBS, fasting insulin, total cholesterol, low-density lipoprotein cholesterol (LDL-C), HOMA1-IR, and HOMA2-IR indicators decreased significantly (P<0.05) after 8 weeks, but the changes were not significant in the placebo group. The mean changes in LDL-C (0.28±0.58 and 0.11±0.67 in intervention and placebo groups, respectively, P=0.036) and QUICKI (0.01±0.03 and 0.02±0.06 in intervention and placebo groups, respectively, P=0.044) were significant between the two groups from the baseline. Conclusions: Psyllium supplementation decreased FBS, fasting insulin, and the lipid profile while improving insulin resistance in non-diabetic women with PCOS.

scholarly journals Effect of 12 weeks of continuous burdock sprout extract intake on oxidized LDL: A placebo-controlled, randomized, double-blind, parallel-groups study

2021 ◽  
Vol 11 (9) ◽  
pp. 456
Author(s):  
Naohito Ito ◽  
Akiko Ohno ◽  
Satoshi Yomoda ◽  
Satoshi Inamasu ◽  
Hiroki Hattori ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Body Mass ◽  
Oxidized Ldl ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Controlled Study ◽  
Double Blind ◽  
Test Food ◽  
Beneficial Effects ◽  
Liver Fibrosis Index

Background: Arctigenin, a lignan polyphenol found in burdock sprout, is a potent activator of AMP-activated protein kinase (AMPK) and has beneficial effects on metabolic disorders in mice. This highlights the potential value of arctigenin for the reduction of oxidized LDL (oxLDL) by activation of AMPK in human, but not well elucidated.Methods: We conducted a placebo-controlled, randomized, double-blind, parallel-groups study in healthy adults to investigate the effects of 12 weeks of a continuous intake of burdock sprout extract enriched with arctigenin on lipid metabolism. The subjects were 100 Japanese individuals with low-density lipoprotein cholesterol (LDL-C) < 140 mg/dl and a body mass index (BMI) of 23–30 kg/m2 who were randomly assigned to receive either burdock sprout extract (test food) or a placebo. The test food was encapsulated burdock sprout extract containing approximately 40 mg of arctigenin equivalent per day, and the placebo capsules contained no burdock sprout extract. The subjects consumed the assigned foods daily for 12 weeks.Results: The test food significantly suppressed oxLDL after 12 weeks in subjects with a body mass index (BMI) of 25 kg/m2 or higher. The test food inhibited an increase in the FIB-4 index (liver fibrosis index), an indicator of hepatic fibrosis. Pearson’s correlation coefficient analysis revealed a significant correlation between oxLDL and FIB-4 index changes, suggesting that the test food suppressed the rise in the FIB-4 index by controlling oxLDL while maintaining the platelet count.Conclusions: We conclude that the consumption of a burdock sprout supplement containing arctigenin is effective in suppressing oxLDL, which may prevent liver fibrosis.Clinical trial registration: UMIN000036664Keywords: arctigenin, burdock sprout, oxidized LDL, FIB-4 index, randomized controlled study

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