Overview

This trial is active, not recruiting.

Conditions hyperlipidemia, metabolic syndrome x
Treatment low fat plant-based nutrition
Sponsor Barbara Jakše s.p.
Start date January 2016
End date December 2016
Trial size 30 participants
Trial identifier NCT02905448, KR2

Summary

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 30 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Low fat plant-based nutrition: low fat plant-based diet supplemented with plant-based meal replacements
low fat plant-based nutrition LFPBD
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. Food intake is taken ad libitum and no calorie counts or restrictions will be applied.

Primary Outcomes

Measure
Serum LDL cholesterol concentration change from baseline
time frame: Baseline, 10 weeks and 30 weeks

Secondary Outcomes

Measure
Serum total cholesterol concentration change from baseline
time frame: Baseline, 10 weeks and 30 weeks
Serum triglyceride concentration change from baseline
time frame: Baseline, 10 weeks and 30 weeks
Fasting serum glucose concentration change from baseline
time frame: Baseline, 10 weeks and 30 weeks
Serum uric acid concentration change from baseline
time frame: Baseline, 10 weeks and 30 weeks
Serum IGF-1 concentration change from baseline
time frame: Baseline, 10 weeks and 30 weeks
Body fat mass change from baseline
time frame: Baseline, 10 weeks and 30 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Self selected free living participants older than 18 years of age - Non overweight, overweight, obese - Sign informed consent for participation in the study Exclusion Criteria: - Pregnant or lactating women, patients with dietary restrictions from a treating physician and patients with active malignant disease were excluded from the study - Already on plant-based (vegan) diet - Competitive or top level athletes - Subjects already taking part in any other interventional dietary program

Additional Information

Official title Low Fat Plant-Based Supplemented Diet Effects on Variety of Risk Factors for Chronic Non-communicable Diseases
Principal investigator Bostjan Jakse, PE teacher
Description This study is designed as a non-randomized, interventional 30 week trial. The dietary intervention is executed in free living conditions with participants engaging in their regular daily work and social activities. The low fat plant-based dietary intervention includes 3 conventional meals based on starch nutrients (potatoes, sweet potatoes, rice, oatmeal, integral pasta, beans, peas, lentils and similar), fruits (seasonal fruits and various berries) and non-starch vegetables (brassicas, leafy vegetables) and 2 plant based meal replacements. Spices and tomato sauce (without oil) and one regular-sized spoon of flax seed is recommended as well. The participants are recommended to consume no more than 5-6 grams of salt per day. All milk and dairy products, vegetable oils and fats are excluded from the diet. Meat is allowed (but not recommended) once weekly. Two meal replacements are prepared by mixing two scoops of the registered plant-based commercially available nutritional powder (Herbalife European Free From vanilla low GI meal replacement with added plants and herbs, without gluten, lactose or soy, source of protein from pea)) with oat meal and fluid (water or plant milk without oil) thus yielding a 250-400 ml of shake. The total macronutrient composition of the intervention diet is approximated/targeted to 15% protein, 70% carbohydrates and 15% fat. Dietary fibre content is approximated to 40-45 g per day. No calorie count or limits are instituted to test the hypothesis that ad libitum intake of interventional diet allows significant body fat reduction and improvement variety of risk factors for chronic non-communicable diseases. All participants will be followed at weekly intervals for body composition indices and at 10 and 30 weeks for serum biochemical end-points. Evaluation of dietary diaries and meal photographs will be used to correct and adjust deviations from the targeted dietary plan and to help participants prepare the meals according to the dietary plan.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Barbara Jakše s.p..