LFPBDS2
Effects of an ad Libitum Consumed Low-fat Plant-based Diet Supplemented With Plant-based Meal Replacements on Variety of Risk Factors for Chronic Non-communicable Diseases
Sponsor study identifier
interventional
36
0 countries
N/A
Study Start
January 2016
Actual (reported)Primary Completion
March 2017
Actual (reported)Study Completion
July 2017
Actual (reported)The effect of a diet free from animal-sourced nutrients on a variety of risk factors for chronic non-communicable diseases in weight reduction programs is not well established. In this non-randomised interventional study, the investigators will document the effects of a low-fat, plant-based diet supplemented with two daily plant-based meal replacements on serum LDL cholesterol as a primary end-point and total cholesterol, triglycerides, serum fasting glucose, serum urate, serum insulin-like growth factor 1 (IGF-1) and body fat mass as secondary end-points. These end-points will be measured at baseline, after 10 weeks and after 36 weeks of intervention. Participants will be enrolled in the interventional arm with prescribed low fat plant-based diet from the group of all applicants to a free living population-based diet optimising program. The choice to participate in the study will be made by participants themselves. The investigators hypothesise that low-fat plant based diet supplemented with plant-based meal replacements eaten ad libitum allows a significant reduction of serum LDL cholesterol concentration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Actual (reported)September 2, 2016
Actual (reported)September 19, 2016
Actual (reported)March 2017
Actual (reported)July 2017
Actual (reported)Serum LDL cholesterol concentration change from baseline
Baseline, 10 weeks and 36 weeks
Serum total cholesterol concentration change from baseline
Baseline, 10 weeks and 36 weeks
Serum triglyceride concentration change from baseline
Baseline, 10 weeks and 36 weeks
Fasting serum glucose concentration change from baseline
Baseline, 10 weeks and 36 weeks
Serum uric acid concentration change from baseline
Baseline, 10 weeks and 36 weeks
Serum IGF-1 concentration change from baseline
Baseline, 10 weeks and 36 weeks
Low fat plant-based nutrition: low fat plant-based diet supplemented with plant-based meal replacements
Conventional low fat plant-based meals free from animal source foods three times daily. Plant-based meal replacement with Herbalife European Free From Vanilla formula two times daily. Herbal beverage two times daily. Dietary fiber supplements is taken three times daily (10-36w) and more high fat whole plant-based foods (avocado, tofu, seeds) Conventional food intake is taken ad libitum and no calorie counts or restrictions will be applied. From 10 to 36 weeks we added vitamin B12 and EPA+DHA fatty acid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Wang F, Zheng J, Yang B, Jiang J, Fu Y, Li D. Effects of Vegetarian Diets on Blood Lipids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2015 Oct 27;4(10):e002408. doi: 10.1161/JAHA.115.002408.
Li Z, Treyzon L, Chen S, Yan E, Thames G, Carpenter CL. Protein-enriched meal replacements do not adversely affect liver, kidney or bone density: an outpatient randomized controlled trial. Nutr J. 2010 Dec 31;9:72. doi: 10.1186/1475-2891-9-72.
Bostjan Jakse, PE teacher
Barbara Jakse s.p.
36 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2016
First Posted
September 19, 2016
Study Start
January 2016
Actual (reported)Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
Contact the study team to confirm eligibility.
Jakse B, Jakse B, Pajek J, Pajek M. Effects of ad libitum consumed, low-fat, high-fiber plant-based diet supplemented with plant-based meal replacements on cardiovascular risk factors. Food Nutr Res. 2019 May 21;63. doi: 10.29219/fnr.v63.1560. eCollection 2019.
Primary Completion
March 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
July 10, 2019
Record last verified: 2019-07
Data will be open to public if demanded by the publication/journal.
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Source: ClinicalTrials.gov.
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