Obesity Clinical Trial
— LFPBDSOfficial title:
Effects of an ad Libitum Consumed Low-fat Plant-based Diet Supplemented With Plant-based Meal Replacements on Body Composition Indices
Verified date | May 2017 |
Source | Barbara Jakše s.p. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 325 |
Est. completion date | October 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Barbara Jakše s.p. |
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. Review. — View 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. Nu — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body fat mass change | Baseline, 10 weeks | ||
Secondary | Body weight change | Baseline, 10 weeks | ||
Secondary | Body weight Follow up | Median time lag of 17.4 months | ||
Secondary | Lean body mass change | Baseline, 10 weeks |
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