Low Fat Plant-based Diet Effects on Body Composition Indices

NCT02906072 | Completed

• 1 other identifier: KR1
• Study Type: interventional
• Target: 325
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Weight Loss

Keywords

Obesity; Body fat; Plant-based diet; Plant-based meal replacement

Outcome Measures

Primary Outcomes (1)

• Body fat mass change

  Baseline, 10 weeks

Secondary Outcomes (3)

• Body weight change

  Baseline, 10 weeks

• Body weight Follow up

  Median time lag of 17.4 months

• Lean body mass change

  Baseline, 10 weeks

Study Arms (2)

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.

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.

Behavioral: Lectures on health effects of a low fat plant-based diet.

Interventions

Low fat plant-based diet BEHAVIORAL

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.

Low fat plant-based diet

Lectures on health effects of a low fat plant-based diet. BEHAVIORAL

Participants attend the lectures on health effects of a low fat plant-based diet.

Control group; Low fat plant-based diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self selected free-living participants older than 18 years of age
• Non overweight, overweight, obese
• Sign informed consent for participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Jakše s.p.: lead

Related Publications (5)

• 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.

  PMID: 25525513 BACKGROUND

• 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.

  PMID: 21194471 BACKGROUND

• 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.

  PMID: 20222968 RESULT

• 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.

  PMID: 25620754 RESULT

• 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.

  PMID: 28459071 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Bostjan Jakse, PE teacher

  Barbara Jakse s.p.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PE teacher

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 19, 2016
• Study Start: January 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share