Low Fat Plant-based Diet Effects on Body Composition Indices (LFPBDS)
Primary Purpose
Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low fat plant-based diet
Lectures on health effects of a low fat plant-based diet.
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Body fat, Plant-based diet, Plant-based meal replacement
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Low fat plant-based diet
Control group
Arm Description
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.
Control participants attend the lectures on health effects of a low fat plant-based diet.
Outcomes
Primary Outcome Measures
Body fat mass change
Secondary Outcome Measures
Body weight change
Body weight Follow up
Lean body mass change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02906072
Brief Title
Low Fat Plant-based Diet Effects on Body Composition Indices
Acronym
LFPBDS
Official Title
Effects of an ad Libitum Consumed Low-fat Plant-based Diet Supplemented With Plant-based Meal Replacements on Body Composition Indices
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Jakše s.p.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Body fat, Plant-based diet, Plant-based meal replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low fat plant-based diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Control participants attend the lectures on health effects of a low fat plant-based diet.
Intervention Type
Behavioral
Intervention Name(s)
Low fat plant-based diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lectures on health effects of a low fat plant-based diet.
Intervention Description
Participants attend the lectures on health effects of a low fat plant-based diet.
Primary Outcome Measure Information:
Title
Body fat mass change
Time Frame
Baseline, 10 weeks
Secondary Outcome Measure Information:
Title
Body weight change
Time Frame
Baseline, 10 weeks
Title
Body weight Follow up
Time Frame
Median time lag of 17.4 months
Title
Lean body mass change
Time Frame
Baseline, 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bostjan Jakse, PE teacher
Organizational Affiliation
Barbara Jakse s.p.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be open to public if demanded by the publication/journal.
Citations:
PubMed Identifier
25525513
Citation
Millstein RA. Measuring outcomes in adult weight loss studies that include diet and physical activity: a systematic review. J Nutr Metab. 2014;2014:421423. doi: 10.1155/2014/421423. Epub 2014 Nov 25.
Results Reference
background
PubMed Identifier
21194471
Citation
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.
Results Reference
background
PubMed Identifier
20222968
Citation
Davis LM, Coleman C, Kiel J, Rampolla J, Hutchisen T, Ford L, Andersen WS, Hanlon-Mitola A. Efficacy of a meal replacement diet plan compared to a food-based diet plan after a period of weight loss and weight maintenance: a randomized controlled trial. Nutr J. 2010 Mar 11;9:11. doi: 10.1186/1475-2891-9-11.
Results Reference
result
PubMed Identifier
25620754
Citation
Barnard ND, Levin SM, Yokoyama Y. A systematic review and meta-analysis of changes in body weight in clinical trials of vegetarian diets. J Acad Nutr Diet. 2015 Jun;115(6):954-69. doi: 10.1016/j.jand.2014.11.016. Epub 2015 Jan 22.
Results Reference
result
PubMed Identifier
28459071
Citation
Jakse B, Pinter S, Jakse B, Bucar Pajek M, Pajek J. Effects of an Ad Libitum Consumed Low-Fat Plant-Based Diet Supplemented with Plant-Based Meal Replacements on Body Composition Indices. Biomed Res Int. 2017;2017:9626390. doi: 10.1155/2017/9626390. Epub 2017 Mar 28.
Results Reference
derived
Learn more about this trial
Low Fat Plant-based Diet Effects on Body Composition Indices
We'll reach out to this number within 24 hrs