Low Fat Plant-Based Supplemented Diet Effects on Risk Factors for Chronic Non-communicable Diseases (LFPBDS2)

July 8, 2019 updated by: Boštjan Jakše, Barbara Jakše s.p.

Effects of an ad Libitum Consumed Low-fat Plant-based Diet Supplemented With Plant-based Meal Replacements on Variety of Risk Factors for Chronic Non-communicable Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a non-randomized, interventional 36 week trial. The dietary intervention is executed in free living conditions with participants engaging in their regular daily work and social activities.

The dietary intervention was executed in free-living conditions with participants engaging in their regular daily work and social activities. The plant-based dietary plan included 2 plant-based meal replacement and 3 conventional meals based on starch nutrients (potatoes, sweet potatoes, rice, oatmeal, whole-grain pasta, beans, peas, lentils, and similar ones), fruits (seasonal fruits and various berries), and nonstarch vegetables (color and leafy vegetables). Spices and tomato sauce (without oil) and one regular-sized spoon of flaxseed were recommended as well. The participants were recommended to consume no more than 5-6 grams of salt per day. All milk and dairy products, vegetable oils, and fats were excluded from the diet. Meat was allowed (but not recommended) once weekly to relieve social pressures on participants which they often encountered from their circle of influence (i.e., family, friends, and coworkers) when changing the diet to plant-based sources. The total macronutrient composition of the intervention diet was approximated to 15% protein, 70% carbohydrates, and 15% fat. No soybean was included in first 10 weeks of intervention. Dietary fiber content was approximated to 40-45 g per day. Both meal replacements and conventional meals were allowed to be consumed ad libitum (to full satiety). No calorie count or limits were instituted. Additionally, two herbal drinks daily containing black, green and hibiscus tea extracts were added to the intervention.

After 10 weeks, we have added to the interventional diet EPA and DHA omega 3 fatty acids (once per day 3 tbl or 567 mg per 1 tbl), vitamin B12 - methylcobalamin (1000 mcg twice a week) and additional intake of dietary fiber supplement powder (three times a day of 5 g) on supplement side and a larger selection of moderate amount of high fat whole plant-based foods (e.g. avocado, soybean tofu, sesame seeds, almonds) at the conventional side.

No calorie count or limits are instituted to test the hypothesis that ad libitum intake of interventional diet allows significant body fat reduction and improvement variety of risk factors for chronic non-communicable diseases.

All participants will be followed at weekly intervals for body composition indices and at 10 and 36 weeks for serum biochemical end-points.

Evaluation of dietary diaries and meal photographs will be used to correct and adjust deviations from the targeted dietary plan and to help participants prepare the meals according to the dietary plan.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 were excluded from the study
  • Already on plant-based (vegan) diet
  • Competitive or top level athletes
  • Subjects already taking part in any other interventional dietary program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low fat plant-based diet
Low fat plant-based nutrition: low fat plant-based diet supplemented with plant-based meal replacements
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

Other Names:
  • LFPBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum LDL cholesterol concentration change from baseline
Time Frame: Baseline, 10 weeks and 36 weeks
Baseline, 10 weeks and 36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum total cholesterol concentration change from baseline
Time Frame: Baseline, 10 weeks and 36 weeks
Baseline, 10 weeks and 36 weeks
Serum triglyceride concentration change from baseline
Time Frame: Baseline, 10 weeks and 36 weeks
Baseline, 10 weeks and 36 weeks
Fasting serum glucose concentration change from baseline
Time Frame: Baseline, 10 weeks and 36 weeks
Baseline, 10 weeks and 36 weeks
Serum uric acid concentration change from baseline
Time Frame: Baseline, 10 weeks and 36 weeks
Baseline, 10 weeks and 36 weeks
Serum IGF-1 concentration change from baseline
Time Frame: Baseline, 10 weeks and 36 weeks
Baseline, 10 weeks and 36 weeks
Body fat mass change from baseline
Time Frame: Baseline, 10 weeks and 36 weeks
Baseline, 10 weeks and 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Jakše s.p.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KR2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be open to public if demanded by the publication/journal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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