Low Fat Plant-based Diet Effects on Body Composition Indices (LFPBDS)

May 26, 2017 updated by: Boštjan Jakše, Barbara Jakše s.p.

Effects of an ad Libitum Consumed Low-fat Plant-based Diet Supplemented With Plant-based Meal Replacements on Body Composition Indices

The effect of a diet free from animal-sourced nutrients on body composition in weight reduction programs is not well established. In this non-randomised free living interventional case-control study, the investigators will document the effects of a 10-week, low-fat, plant-based diet supplemented with two daily plant-based meal replacements on body composition indices measured with bioimpedance analysis. Control subjects will be exposed to weekly lectures on the rationale and expected benefits of plant-based nutrition. The investigators hypothesise that low-fat plant based diet supplemented with meal replacements eaten ad libitum allows a significant reduction of body fat without the loss of lean tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a non-randomized, interventional case-control trial, followed by a post-intervention survey of a free living diet optimizing program.

The dietary intervention is executed in free living conditions with participants engaging in their regular daily work and social activities. The plant-based dietary plan 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.

Participants who, after an introductory program presentation, opt not to follow the proposed dietary intervention including meal replacements, but only to attend the lectures on health effects of a low-fat plant-based diet, adjust their diet by their own judgment and attend weekly body composition follow-up measurements, serve as controls.

All participants are followed at weekly intervals. Evaluation of dietary diaries and meal photographs are used to correct and adjust deviations from the targeted dietary plan and to help participants prepare the meals according to the dietary plan. Weekly lectures about the rationale and guidance on attaining the low-fat plant-based diet are given to all subjects (intervention and control group).

Differences between groups will be tested with t-test for unpaired and paired samples, as appropriate. Mann-Whitney and Wilcoxon Signed Rank tests will be used for non-normally distributed data. Chi-square test will be used for categorical variables. Differences between cases and controls will be tested with analysis of covariance (general linear model), with adjustment for baseline variable status, age and sex.

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 are excluded from the study
  • Already on plant-based (vegan) diet
  • Competitive or top level athletes
  • Subjects who take part in any other interventional dietary program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low fat plant-based diet
Low fat plant-based diet with conventional meals and supplemented with plant-based meal replacements and participants attend the lectures on health effects of a low fat plant-based diet.
Behavioral: Low fat plant-based diet
Conventional low fat plant-based meals three times daily. Plant-based meal replacements: Herbalife European Free From vanilla two times daily. Portion sizes and intake is unrestricted.
Behavioral: Lectures on health effects of a low fat plant-based diet.
Participants attend the lectures on health effects of a low fat plant-based diet.
Other: Control group
Control participants attend the lectures on health effects of a low fat plant-based diet.
Behavioral: Lectures on health effects of a low fat plant-based diet.
Participants attend the lectures on health effects of a low fat plant-based diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body fat mass change
Time Frame: Baseline, 10 weeks
Baseline, 10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight change
Time Frame: Baseline, 10 weeks
Baseline, 10 weeks
Body weight Follow up
Time Frame: Median time lag of 17.4 months
Median time lag of 17.4 months
Lean body mass change
Time Frame: Baseline, 10 weeks
Baseline, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Jakše s.p.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be open to public if demanded by the publication/journal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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