Effect of a dietary intervention including minimal and unprocessed foods, high in natural saturated fats, on the lipid profile of children, pooled evidence from randomized controlled trials and a cohort study

Aim To study the possible effects of a dietary intervention with minimal and unprocessed foods, high in natural saturated fats on the lipid profile and body mass index of children. Method This study combines three intervention studies; one non-randomized retrospective cohort study and two randomized controlled trials, to a pooled analysis. The intervention group received a dietary intervention of minimal and unprocessed foods for three to six months, consisting of five times per week green vegetables, three times per week beef, daily 200–300 mL whole cow’s milk (3.4% fat) and whole dairy butter (80% fat) on each slice of bread. The control group continued their usual dietary habits. Raw data of the three intervention studies where combined into one single dataset for data analysis, using mixed effects analysis of covariance to test the effects of the dietary advice on the main study outcomes, which are measurements of the lipid profile. Results In total, 267 children aged 1 to 16 years were followed. 135 children were included in the intervention group and 139 children in the control group. Characteristics (age, gender and follow-up period) were equally distributed between the groups at baseline. In the intervention group HDL-cholesterol increased significantly from 1.22 mmol/L, 95% confidence interval (CI) 1.14–1.32 to 1.42 mmol/L 95% CI 1.30–1.65 (p = 0.007). The increase over time in HDL cholesterol in the intervention group was significantly different compared to the increase in the control group (from 1.26 mmol/L, 95% CI 1.19–1.35, to 1.30 mmol/L, 95% CI 1.26–1.37) (p = 0.04). Due to the increased HDL concentration in the intervention group, the total cholesterol/HDL cholesterol ratio decreased significantly from 3.70 mmol/L, 95% CI 3.38–3.87, to 3.25 mmol/L, 95% CI 2.96–3.31 (p = 0.05). Conclusion Consumption of minimal and unprocessed foods (high in natural saturated fats) has favourable effects on HDL cholesterol in children. Therefore, this dietary advice can safely be recommended to children.

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The consumption of low-calorie sweetener containing foods during pregnancy: results from the ROLO study

European Journal of Clinical Nutrition ◽

10.1038/s41430-021-00935-0 ◽

2021 ◽

Author(s):

Marie C. Conway ◽

Shona Cawley ◽

Aisling A. Geraghty ◽

Niamh M. Walsh ◽

Eileen C. O’Brien ◽

...

Keyword(s):

Pregnant Women ◽

Dietary Intervention ◽

Intervention Group ◽

Glycaemic Index ◽

Dietary Advice ◽

Control Group ◽

Food Groups ◽

Food Diary ◽

Low Calorie ◽

Child Health Outcomes

Abstract Background/objectives Women with gestational diabetes (GDM) are advised to adapt a low glycaemic index (GI) diet, which may impact consumption of low-calorie sweeteners (LCS). LCS are increasingly popular as they add sweetness without contributing calories. This study aims to investigate the reported intakes of LCS-containing foods in women during pregnancy. Subjects/methods Pregnant women recruited for the ROLO study were included in this analysis (n = 571). Women were randomised to receive either an intervention of low-GI dietary advice or usual antenatal care. Women completed a 3-day food diary in each trimester. Nine LCS-containing food groups were identified, and the quantity (g/day) consumed was calculated. Results One-third of all pregnant women consumed LCS across each trimester of pregnancy. Of those in the intervention group who were LCS consumers in trimester 1, 71.6% were consumers in trimester 2, and 54.1% remained consumers in trimester 3. In the control group, less women remained consumers in trimester 2 and 3 at 58.1% and 41.9%, respectively. In trimester 2, following the dietary intervention, the proportion of LCS consumers in the intervention group was significantly higher than the proportion of consumers who were in the control group (p < 0.001). The most commonly consumed food groups were low-calorie fruit drinks, diet-cola drinks, and low-calorie yoghurts. Conclusions One-third of pregnant women consumed LCS. The proportion of LCS consumers increased in the intervention group compared to the control group. Further research is needed to determine exposure levels to individual LCS, and the effect of prenatal exposure to LCS on maternal and child health outcomes.

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CADRES COMPETENCE IN COMMUNITY-BASED MANAGEMENT OF CHILD ILLNESS IN BANYUMAS DISTRICT, CENTRAL JAVA, INDONESIA

Belitung Nursing Journal ◽

10.33546/bnj.542 ◽

2018 ◽

Vol 4 (5) ◽

pp. 492-501

Author(s):

Umi Solikhah ◽

Hari Kusnanto ◽

Fitri Haryanti ◽

Yayi Suryo Prabandari

Keyword(s):

Randomized Controlled Trials ◽

Health Center ◽

Health Workers ◽

Intervention Group ◽

T Test ◽

Control Group ◽

P Value ◽

Controlled Trials ◽

Child Illness ◽

Randomized Controlled

Background: One of the efforts in the health sector for programs to reduce infant and under-five mortality and morbidity rates is by the competence-based integrated management childhood illness (CB-IMCI) program. However, the program has been poorly implemented by health workers at the health center. Thus, the involvement of cadres is needed and their competency remains important to be improved.Objective: To quantitatively analyze cadre knowledge and competencies in the CB-IMCI program, and its relationship with the implementation of CB-IMCI, as well as to qualitatively explore and analyze the responses of cadres, health workers, and the community to the addition of cadre roles to the management of sick children.Methods: This was a mixed methods study with randomized controlled trials and qualitative method. For randomized controlled trials, 100 cadres were selected, which 50 randomly assigned in the intervention and control group. And for quantitative methods, informants included 10 cadres, 4 health workers, and 20 mothers. Paired t-test and independent t-test were employed for quantitative analysis, and triangulation was used for qualitative analysis.Results: The improvement of knowledge in the intervention group was better (I=14.42/C=4.44/p-value 0.00). The intervention group was more competent in the management of child illness (p-value 0.00). In addition, the cadres have additional competencies assisted by health workers to confidently detect cases earlier, and health center services reach a wider coverage in the community.Conclusion: The addition of cadres roles and competencies in the management of child illness in the community can be implemented in Banyumas Regency. It is suggested that the implementation of this program should be followed up in other health centers by the health department of Indonesia.

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The influence of a dietary advice on recurrent upper respiratory tract infections in children: a randomized controlled trial.

Proceedings of The Nutrition Society ◽

10.1017/s0029665120002554 ◽

2020 ◽

Vol 79 (OCE2) ◽

Author(s):

Ellen van der Gaag ◽

Ruben Brandsema ◽

Job van der Palen ◽

Thalia Hummel

Keyword(s):

Supportive Care ◽

Respiratory Tract Infections ◽

Controlled Trial ◽

Intervention Group ◽

Dietary Advice ◽

Control Group ◽

Upper Respiratory Tract ◽

Randomized Controlled ◽

Upper Respiratory ◽

Tract Infections

AbstractIntroductionSince there is no treatment for children suffering from upper respiratory tract infections (URTI) without immunological disorders, we searched for a possible tool to improve the health of these children.We evaluated whether a dietary advice including standard supportive care, can decrease the number and duration of URTI compared to standard supportive care in children aged 1–4 years with recurrent URTI.Material and MethodsDesign: A multicenter randomized controlled trial, with an intervention group receiving the dietary advice plus standard supportive care and a control group receiving standard supportive care alone.Setting: 3 Outpatient clinics in The Netherlands (urban and rural).Patients: 118 Children aged 1–4 years with recurrent URTIs.Intervention: A dietary advice consisting of five times per week green vegetables, 3 times per week beef, 300 mL whole milk per day, whole dairy butter on bread every day. Portion sizes are age appropriate. The intervention lasted for 6 months.ResultsChildren in the intervention group had 4.8 (1.6–9.5) days per month with symptoms of an URTI in the last three months of the study, compared to 7.7 (4.0–12.3) in the control group (p = 0.03). The total number of URTIs during the study period of 6 months was 5,7 (± 0,55) versus 6.8 (± 0,49) respectively (p = 0.068). Total use of antibiotics was markedly reduced in the intervention group (p = 0.034), as well as the visits to the general practitioner (p = 0.031), therefore possibly reducing healthcare costs.No adverse effects were observed in the lipid profiles, nor in growth parameters (weight, height, BMI).Discussion and conclusionsThis study shows a reduced number of days with symptoms of an URTI following a dietary advice consisting of green vegetables, beef and whole diary products. It did not significantly lower the number of infections. No adverse effects were observed.RegistrationThis trial is registered in the Dutch Trial Register, NTR4898, www.trialregister.nl.

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A Lifestyle (Dietary) Intervention Reduces Tiredness in Children with Subclinical Hypothyroidism, a Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17103689 ◽

2020 ◽

Vol 17 (10) ◽

pp. 3689

Author(s):

Ellen van der Gaag ◽

Job van der Palen ◽

Pim Schaap ◽

Mirthe van Voorthuizen ◽

Thalia Hummel

Keyword(s):

Lipid Profile ◽

Subclinical Hypothyroidism ◽

Dietary Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Thyroid Stimulating Hormone ◽

Control Group ◽

Significant Difference ◽

Scale Scores

Purpose: Subclinical hypothyroidism (SH) in children and adults is a subject for discussion in terms of whether to treat it or not with respect to the short-term clinical implications and consequences of SH and in the long term. If treatment with thyroxine supplementation is not indicated, no other treatment is available. We investigated whether a lifestyle (dietary) intervention improves or normalizes SH or decreases the presence of Thyroid Stimulating Hormone (TSH) and/or tiredness. Methods: We randomized children aged 1–12 years with SH to the control group (standard care = no treatment) or intervention group (dietary intervention). The dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months. The rest of the diet remained unchanged. We measured TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores. Results: In total, 62 children were included. After 6 months, TSH decreased in both groups without a significant difference between the groups (p = 0.98). PedQL fatigue scores for sleep (p = 0.032) and total fatigue scores (p = 0.039) improved significantly in the intervention group, compared to the control group. No unfavorable effects occurred in the lipid profile or BMI. Conclusion: The lifestyle (dietary) intervention did not normalize SH and TSH levels, but it significantly reduced tiredness. These results suggest that children’s well-being can be improved without medication.

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Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

European Journal of Clinical Nutrition ◽

10.1038/ejcn.2016.78 ◽

2016 ◽

Vol 70 (11) ◽

pp. 1221-1229 ◽

Cited By ~ 22

Author(s):

T Isomura ◽

S Suzuki ◽

H Origasa ◽

A Hosono ◽

M Suzuki ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Green Tea ◽

Case Reports ◽

Intervention Group ◽

Control Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled

Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5–9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

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Malnutrition in an obese world: Can a dietary intervention improve iron status in pre-school children?

Proceedings of The Nutrition Society ◽

10.1017/s0029665120003316 ◽

2020 ◽

Vol 79 (OCE2) ◽

Author(s):

Ellen van der Gaag ◽

Kim Grootelaar ◽

Thalia Hummel

Keyword(s):

Iron Deficiency ◽

School Children ◽

Dietary Intervention ◽

Growth Parameters ◽

Iron Status ◽

Controlled Trial ◽

Intervention Group ◽

Dietary Advice ◽

Control Group ◽

National Guidelines

AbstractIntroduction:In previous studies iron deficiency was present in preschool children in the developed world1. The objective of this randomized controlled trial was to investigate whether iron deficiency was present in pre-school children and to what extend laboratory values could be improved with a nutrient rich diet.Material and Methods:A diet consisting of green vegetables, beef, full-fat milk and butter was developed. This diet comes close to the traditional Dutch diet from a century ago. All food products were in age appropriate portions, according to the national guidelines. Children aged one to four years, who were referred to the paediatrician due to recurrent URTI (without immunologic disorders) were allocated to the intervention or the control group. Both groups were given standard care. The intervention group was also given the dietary advise. All parents were asked to note of daily food intake.Results:No iron deficiency was present in our group of 1–4 years old. Mean Hb was 7.3 mmol/l in both groups. After following the dietary advice for 6 months,the hemoglobulin (Hb) concentration increased in both groups, but a little more in the intervention group :(0,280 mmol/l; p < 0,001 in the dietary intervention group and 0,214 mmol/l in the control group; p = 0,003). MCV values increased in the interventiongroup from 77.9 to 78.8 fl (p = 0.007) whereas a smaller increase was visible in the control group ;78.5 to 78.9 fl (p = 0.18). Ferritin, a marker for iron status but also a marker for inflammation, decreased non-significantly in both groups. There was a significantly correlation with decreasing CRP levels, therefore indicating a decrease in inflammation and not merely representing iron status. Growth parameters (weight, height or BMI) did not change significantly in both groups.Discussion and Conclusion:NoHb deficiency was present in our research population. However, a diet consisting of green vegetables, beef, full-fat milk and butter did improve the iron status in pre-school children. Hb and MCV values increased, suggesting some evidence of subclinical iron deficiency in this group.

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Pengaruh pemberian ekstrak tinta cumi (squid ink) terhadap aterosklerosis

Jurnal e-Biomedik ◽

10.35790/ebm.5.2.2017.16612 ◽

2017 ◽

Vol 5 (2) ◽

Author(s):

Fajar M. Nasution ◽

Rina S. Mardia ◽

Ayu Azri ◽

Rido R. Hutabarat ◽

Fadhila Al. Izza ◽

...

Keyword(s):

Lipid Profile ◽

Wistar Rats ◽

Ldl Cholesterol ◽

Hdl Cholesterol ◽

Foam Cells ◽

Control Group ◽

Test Design ◽

Randomized Controlled ◽

Post Test ◽

Paired T Test

Abstract: Squid ink consists of DHI, DHICA, and 2-carboxyl indole that improve lipid profile and remove foam cells in blood vessel walls. This study was aimed to analyze the effect of squid ink on atherosclerosis-induced Wistar rats. This was an experimental study. We used randomized controlled trial with pre-post test design for lipid profile assessment and randomized post-test only control design for blood vessel evaluation (foam cells in layers of coronary artery). Samples were 27 Wistar rats, divided into three groups; all were atherosclerosis-induced with initial injection of 0.006mg iv adrenalin on day 1, followed by standard diet and egg yolk until day 30. Squid ink extract was given to group P1 and P2 on days 15-30 in different doses, but not to control group. Data were analyzed by using Saphiro-Wilk test and paired t-test. The results showed that P2 group had decreased means of total cholesterol (-33.62 mg/dl), triglyceride (-28.00 mg/dl), and LDL cholesterol (-28.16 mg/dl), but an increased mean of HDL cholesterol (11.60 mg/dl). There were decreased numbers of foam cells in the layers of coronary arteries of P1 and P2 group compared to the control group. Conclusion: Squid ink extract could lower total cholesterol, triglyceride, and LDL cholesterol levels, and increase HDL cholesterol level. Moreover, it could remove foam cells from the layers of coronary arteries.Keywords: squid ink, atherosclerosis, lipid profile, foam cells Asbtrak: Tinta cumi memiliki kandungan DHI, DHICA, dan 2-carboxyl indole yang dapat memperbaiki profil lipid dan mengurangi sel busa pembuluh darah. Penelitian ini bertujuan untuk mengetahui pengaruh pemberian ekstrak tinta cumi terhadap tikus yang diinduksi aterosklerosis. Jenis penelitian ialah eksperimental dengan randomized controlled with pre-post test design untuk penilaian profil lipid dan post test only design untuk penilaian pembuluh darah (sel busa dalam dinding arteri koronaria). Sampel terdiri dari 27 tikus Wistar jantan, dibagi secara random menjadi tiga kelompok; kesemuanya diberi induksi aterosklerosis dengan injeksi inisial adrenalin 0,006 mg iv pada hari ke-1, dilanjutkan diet standar dan diet kuning telur sampai hari ke-30. Tikus kelompok kontrol tidak diberikan ekstrak tinta cumi; tikus kelompok perlakuan 1 dan perlakuan 2 diberikan tambahan ekstrak tinta cumi pada hari ke 16 sampai hari ke 30 dengan dosis yang berbeda. Analisis data dengan uji Saphiro-Wilk dan uji paired t-test. Hasil penelitian memperlihatkan penurunan rerata setelah perlakuan pada kelompok P2 ialah kolesterol total (-33,62 mg/dl), trigliserida (-28,00 mg/dl), dan kolesterol LDL (-28,16 mg/dl), serta peningkatan rerata kolesterol HDL (11,60 mg/dl). Terdapat penurunan jumlah sel busa kelompok perlakuan P1 dan P2 dibandingkan kelompok kontrol. Simpulan: Pemberian ekstrak tinta cumi menurunkan kadar kolesterol total, trigliserida dan kolesterol LDL, meningkatkan kadar kolesterol HDL, serta menurunkan jumlah sel busa dalam dinding arteri koronaria.Kata kunci: tinta cumi, aterosklerosis, profil lipid, sel busa

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Tai Chi as a Therapy of Traditional Chinese Medicine on Reducing Blood Pressure: A Systematic Review of Randomized Controlled Trials

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/4094325 ◽

2021 ◽

Vol 2021 ◽

pp. 1-13

Author(s):

Xiandu Pan ◽

Li Tian ◽

Fan Yang ◽

Jiahao Sun ◽

Xinye Li ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Controlled Trials ◽

Tai Chi ◽

Meta Analysis ◽

Bodily Pain ◽

Intervention Group ◽

Control Group ◽

Controlled Trials ◽

Randomized Controlled ◽

Tai Chi Exercise

Objective. This study systematically evaluated the effects of Tai Chi exercise on blood pressure, body mass index (BMI), and quality of life (QOL) in patients with hypertension. A meta-analysis was performed to provide a reliable reference for clinical practice. Methods. We searched for randomized controlled trials (RCTs) in five English databases and two Chinese databases, with the earliest data dated December 5, 2020. A quality assessment of the methods and a meta-analysis were also conducted. Results. The meta-analysis of 24 studies showed that the intervention group showed better outcomes in terms of systolic blood pressure (SBP) (SMD −1.05, 95% CI −1.44 to −0.67, P ≤ 0.001 ; I2 = 93.7%), diastolic blood pressure (DBP) (SMD −0.91, 95% CI −1.24 to −0.58, P ≤ 0.001 ; I2 = 91.9%), and QOL (physical functioning (SMD 0.86, 95% CI 0.36 to 1.37, P = 0.001 ; I2 = 91.3%), role-physical (SMD 0.86, 95% CI 0.61 to 1.11, P ≤ 0.001 ; I2 = 65%), general health (SMD 0.75, 95% CI 0.32 to 1.17, P = 0.001 ; I2 = 88.1%), bodily pain (SMD 0.65, 95% CI 0.29 to 1.00, P ≤ 0.001 ; I2 = 83.1%), vitality (SMD 0.71, 95% CI 0.34 to 1.07, P ≤ 0.001 ; I2 = 84.3%), social functioning (SMD 0.63, 95% CI 0.07 to 1.19, P = 0.027 ; I2 = 93.1%), role-emotional (SMD 0.64, 95% CI 0.22 to 1.06, P = 0.003 ; I2 = 88.1%), and mental health (SMD 0.73, 95% CI 0.31 to 1.16, P = 0.001 ; I2 = 88.2%)) compared to those of the control group. However, no significant improvements were seen in BMI of the intervention group (SMD −0.08, 95% CI −0.35 to −0.19, P = 0.554 ; I2 = 69.4%) compared to that of the control group. Conclusion. Tai Chi is an effective intervention to improve SBP and DBP in patients with essential hypertension.

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Some Reflections on Randomized Controlled Trials

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462300002750 ◽

1986 ◽

Vol 2 (1) ◽

pp. 39-42 ◽

Cited By ~ 2

Author(s):

Tore Scherstén

Keyword(s):

Medical Technology ◽

Statistical Tests ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Trials ◽

Type Ii ◽

Type Ii Error ◽

Safety And Efficacy ◽

Randomized Controlled

Few would argue that the randomized clinical trial is the most definitive instrument available for measuring the safety and efficacy of a new medical technology, be it drug, device, or procedure. Randomization removes the potential for bias in the allocation of subjects to the intervention group or to the control group. In addition, randomization tends to produce comparable groups which can be further strengthened by stratification and by stratified analyses. The randomized controlled trial guarantees validity of statistical tests, as long as the sample size is large enough to avoid type-II error.

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A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

Journal of Public Health ◽

10.1093/pubmed/fdy117 ◽

2018 ◽

Vol 41 (2) ◽

pp. 371-378 ◽

Cited By ~ 2

Author(s):

R A K Kennedy ◽

C M E Reynolds ◽

S Cawley ◽

E O’Malley ◽

D M McCartney ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Standard Care ◽

Dietary Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Neonatal Outcomes ◽

Dietary Behaviour ◽

Control Group ◽

Evidence Based ◽

Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

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