ObesityLFPBDSNCT02906072
Low Fat Plant-based Diet Effects on Body Composition Indices
A study testing Low fat plant-based diet and Lectures on health effects of a low fat plant-based diet. in people with Obesity and Weight Loss, run by Barbara Jakše s.p..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Low fat plant-based diet and Lectures on health effects of a low fat plant-based diet.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self selected free-living participants older than 18 years of age
- Non overweight, overweight, obese
- Sign informed consent for participation in the study
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Low fat plant-based diet, Lectures on health effects of a low fat plant-based diet.
- Keywords
- Obesity, Body fat, Plant-based diet, Plant-based meal replacement
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat plant-based dietBehavioural
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.
Lectures on health effects of a low fat plant-based diet.Behavioural
Participants attend the lectures on health effects of a low fat plant-based diet.
| Study group | Role | What they receive |
|---|---|---|
| Low fat plant-based diet | Experimental | 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. Receives: Behavioral: Low fat plant-based diet; Behavioral: Lectures on health effects of a low fat plant-based diet. |
| Control group | Other | Control participants attend the lectures on health effects of a low fat plant-based diet. Receives: Behavioral: Lectures on health effects of a low fat plant-based diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat mass change
Measured: Baseline, 10 weeks
Secondary outcomes (3)
Body weight change
Measured: Baseline, 10 weeks
Body weight Follow up
Measured: Median time lag of 17.4 months
Lean body mass change
Measured: Baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJan 2011
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Jakše s.p.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boštjan Jakše, Barbara Jakše s.p.
- Investigators
- Bostjan Jakse, PE teacher, Principal investigator, Barbara Jakse s.p.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906072
- Sponsor's protocol ID
- KR1
- Acronym
- LFPBDS
- Status last verified
- May 2017
- First submitted
- 2 Sep 2016
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be open to public if demanded by the publication/journal.
Publications
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.
PubMed 25525513Li 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.
PubMed 21194471Davis 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.
PubMed 20222968Barnard 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.
PubMed 25620754Jakse 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.
PubMed 28459071
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an ad Libitum Consumed Low-fat Plant-based Diet Supplemented With Plant-based Meal Replacements on Body Composition Indices
- ClinicalTrials.gov ID
- NCT02906072
- Acronym / sponsor ID
- LFPBDS / KR1
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Body fat, Plant-based diet, Plant-based meal replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Barbara Jakše s.p.University, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fat plant-based diet | Experimental | Behavioral: Low fat plant-based diet, Behavioral: Lectures on health effects of a 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. |
| Control group | Other | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self selected free-living participants older than 18 years of age
- Non overweight, overweight, obese
- Sign informed consent for participation in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fat plant-based dietConventional 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. | Behavioural | Low fat plant-based diet |
| 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. | Behavioural | Control group, Low fat plant-based diet |
Primary outcome
Body fat mass change
Time frame: Baseline, 10 weeks
3 secondary outcomes
Body weight change
Time frame: Baseline, 10 weeks
Body weight Follow up
Time frame: Median time lag of 17.4 months
Lean body mass change
Time frame: Baseline, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 25525513Millstein 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.
- Background: PubMed 21194471Li 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 publication: PubMed 20222968Davis 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 publication: PubMed 25620754Barnard 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.
- Derived from this study: PubMed 28459071Jakse 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.
- Individual participant dataSharing planned: Yes. Data will be open to public if demanded by the publication/journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bostjan Jakse, PE teacher principal investigator
Barbara Jakse s.p.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat plant-based diet and Lectures on health effects of a low fat plant-based diet. in people with Obesity and Weight Loss, run by Barbara Jakše s.p..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat mass change (time frame: Baseline, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906072, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.