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Low Fat Plant-Based Supplemented Diet Effects on Risk Factors for Chronic Non-communicable Diseases

NCT02905448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-07-10

No results posted yet for this study

Summary

The effect of a diet free from animal-sourced nutrients on a variety of risk factors for chronic non-communicable diseases in weight reduction programs is not well established. In this non-randomised interventional study, the investigators will document the effects of a low-fat, plant-based diet supplemented with two daily plant-based meal replacements on serum LDL cholesterol as a primary end-point and total cholesterol, triglycerides, serum fasting glucose, serum urate, serum insulin-like growth factor 1 (IGF-1) and body fat mass as secondary end-points. These end-points will be measured at baseline, after 10 weeks and after 36 weeks of intervention. Participants will be enrolled in the interventional arm with prescribed low fat plant-based diet from the group of all applicants to a free living population-based diet optimising program. The choice to participate in the study will be made by participants themselves.

The investigators hypothesise that low-fat plant based diet supplemented with plant-based meal replacements eaten ad libitum allows a significant reduction of serum LDL cholesterol concentration.

Conditions

Interventions

OTHER

Low fat plant-based nutrition

Conventional low fat plant-based meals free from animal source foods three times daily. Plant-based meal replacement with Herbalife European Free From Vanilla formula two times daily. Herbal beverage two times daily. Dietary fiber supplements is taken three times daily (10-36w) and more high fat whole plant-based foods (avocado, tofu, seeds) Conventional food intake is taken ad libitum and no calorie counts or restrictions will be applied. From 10 to 36 weeks we added vitamin B12 and EPA+DHA fatty acid

Sponsors & Collaborators

  • Barbara Jakše s.p.

    lead OTHER

Principal Investigators

  • Bostjan Jakse, PE teacher · Barbara Jakse s.p.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-03-31
Completion
2017-07-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02905448 on ClinicalTrials.gov