HyperlipidemiaLFPBDS2NCT02905448
Low Fat Plant-Based Supplemented Diet Effects on Risk Factors for Chronic Non-communicable Diseases
A study testing Low fat plant-based nutrition in people with Hyperlipidemia and Metabolic Syndrome X, run by Barbara Jakše s.p..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Metabolic Syndrome X
- What is being tested?
- Low fat plant-based nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self selected free living participants older than 18 years of age
- Non overweight, overweight, obese
- Sign informed consent for participation in the study
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Hyperlipidemia, Metabolic Syndrome X
- Being tested
- Low fat plant-based nutrition
- Keywords
- Obesity, Body composition, Atherosclerosis, Insulin resistance, Hyperuricemia
- Medical subject headings
- Hyperlipidemias, Metabolic Syndrome, Obesity, Atherosclerosis, Insulin Resistance, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat plant-based nutritionOther
Also called LFPBD
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
| Study group | Role | What they receive |
|---|---|---|
| Low fat plant-based diet | Experimental | Low fat plant-based nutrition: low fat plant-based diet supplemented with plant-based meal replacements Receives: Other: Low fat plant-based nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum LDL cholesterol concentration change from baseline
Measured: Baseline, 10 weeks and 36 weeks
Secondary outcomes (6)
Serum total cholesterol concentration change from baseline
Measured: Baseline, 10 weeks and 36 weeks
Serum triglyceride concentration change from baseline
Measured: Baseline, 10 weeks and 36 weeks
Fasting serum glucose concentration change from baseline
Measured: Baseline, 10 weeks and 36 weeks
Serum uric acid concentration change from baseline
Measured: Baseline, 10 weeks and 36 weeks
Serum IGF-1 concentration change from baseline
Measured: Baseline, 10 weeks and 36 weeks
Body fat mass change from baseline
Measured: Baseline, 10 weeks and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Jakše s.p.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boštjan Jakše, Barbara Jakše s.p.
- Investigators
- Bostjan Jakse, PE teacher, Principal investigator, Barbara Jakse s.p.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905448
- Sponsor's protocol ID
- KR2
- Acronym
- LFPBDS2
- Status last verified
- Jul 2019
- First submitted
- 2 Sep 2016
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be open to public if demanded by the publication/journal.
Publications
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.
PubMed 26508743Li 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.
PubMed 21194471Jakse 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.
PubMed 31191190
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02905448
- Acronym / sponsor ID
- LFPBDS2 / KR2
- Conditions
- Hyperlipidemia, Metabolic Syndrome X
- Keywords
- Obesity, Body composition, Atherosclerosis, Insulin resistance, Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Barbara Jakše s.p.University, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low fat plant-based diet | Experimental | Other: Low fat plant-based nutritionLow fat plant-based nutrition: low fat plant-based diet supplemented with plant-based meal replacements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self selected free living participants older than 18 years of age
- Non overweight, overweight, obese
- Sign informed consent for participation in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fat plant-based nutritionAlso: LFPBDConventional 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 | Low fat plant-based diet |
Primary outcome
Serum LDL cholesterol concentration change from baseline
Time frame: Baseline, 10 weeks and 36 weeks
6 secondary outcomes
Serum total cholesterol concentration change from baseline
Time frame: Baseline, 10 weeks and 36 weeks
Serum triglyceride concentration change from baseline
Time frame: Baseline, 10 weeks and 36 weeks
Fasting serum glucose concentration change from baseline
Time frame: Baseline, 10 weeks and 36 weeks
Serum uric acid concentration change from baseline
Time frame: Baseline, 10 weeks and 36 weeks
Serum IGF-1 concentration change from baseline
Time frame: Baseline, 10 weeks and 36 weeks
Body fat mass change from baseline
Time frame: Baseline, 10 weeks and 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Background: PubMed 26508743Wang 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.
- Background: PubMed 21194471Li 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.
- Background: PubMed 31191190Jakse 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.
- Individual participant dataSharing planned: Yes. Data will be open to public if demanded by the publication/journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bostjan Jakse, PE teacher principal investigator
Barbara Jakse s.p.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat plant-based nutrition in people with Hyperlipidemia and Metabolic Syndrome X, run by Barbara Jakše s.p..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum LDL cholesterol concentration change from baseline (time frame: Baseline, 10 weeks and 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905448, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.