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

Primary Purpose

Hyperlipidemia, Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low fat plant-based nutrition
Sponsored by
Barbara Jakše s.p.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia focused on measuring Obesity, Body composition, Atherosclerosis, Insulin resistance, Hyperuricemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Low fat plant-based diet

    Arm Description

    Low fat plant-based nutrition: low fat plant-based diet supplemented with plant-based meal replacements

    Outcomes

    Primary Outcome Measures

    Serum LDL cholesterol concentration change from baseline

    Secondary Outcome Measures

    Serum total cholesterol concentration change from baseline
    Serum triglyceride concentration change from baseline
    Fasting serum glucose concentration change from baseline
    Serum uric acid concentration change from baseline
    Serum IGF-1 concentration change from baseline
    Body fat mass change from baseline

    Full Information

    First Posted
    September 2, 2016
    Last Updated
    July 8, 2019
    Sponsor
    Barbara Jakše s.p.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02905448
    Brief Title
    Low Fat Plant-Based Supplemented Diet Effects on Risk Factors for Chronic Non-communicable Diseases
    Acronym
    LFPBDS2
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Barbara Jakše s.p.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemia, Metabolic Syndrome X
    Keywords
    Obesity, Body composition, Atherosclerosis, Insulin resistance, Hyperuricemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low fat plant-based diet
    Arm Type
    Experimental
    Arm Description
    Low fat plant-based nutrition: low fat plant-based diet supplemented with plant-based meal replacements
    Intervention Type
    Other
    Intervention Name(s)
    Low fat plant-based nutrition
    Other Intervention Name(s)
    LFPBD
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Serum LDL cholesterol concentration change from baseline
    Time Frame
    Baseline, 10 weeks and 36 weeks
    Secondary Outcome Measure Information:
    Title
    Serum total cholesterol concentration change from baseline
    Time Frame
    Baseline, 10 weeks and 36 weeks
    Title
    Serum triglyceride concentration change from baseline
    Time Frame
    Baseline, 10 weeks and 36 weeks
    Title
    Fasting serum glucose concentration change from baseline
    Time Frame
    Baseline, 10 weeks and 36 weeks
    Title
    Serum uric acid concentration change from baseline
    Time Frame
    Baseline, 10 weeks and 36 weeks
    Title
    Serum IGF-1 concentration change from baseline
    Time Frame
    Baseline, 10 weeks and 36 weeks
    Title
    Body fat mass change from baseline
    Time Frame
    Baseline, 10 weeks and 36 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bostjan Jakse, PE teacher
    Organizational Affiliation
    Barbara Jakse s.p.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be open to public if demanded by the publication/journal.
    Citations:
    PubMed Identifier
    26508743
    Citation
    Wang F, Zheng J, Yang B, Jiang J, Fu Y, Li D. Effects of Vegetarian Diets on Blood Lipids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2015 Oct 27;4(10):e002408. doi: 10.1161/JAHA.115.002408.
    Results Reference
    background
    PubMed Identifier
    21194471
    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.
    Results Reference
    background
    PubMed Identifier
    31191190
    Citation
    Jakse B, Jakse B, Pajek J, Pajek M. Effects of ad libitum consumed, low-fat, high-fiber plant-based diet supplemented with plant-based meal replacements on cardiovascular risk factors. Food Nutr Res. 2019 May 21;63. doi: 10.29219/fnr.v63.1560. eCollection 2019.
    Results Reference
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    Low Fat Plant-Based Supplemented Diet Effects on Risk Factors for Chronic Non-communicable Diseases

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