HypertensionNCT03134235
Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
A study testing Dietary Intervention in people with Hypertension and Elevated Cholesterol, run by Texas Woman's University at 1 site in United States.
Trial summary
This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Elevated Cholesterol, Overweight and Obesity
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 15 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index ≥25.0 kg/m^2
- Serum low-density lipoprotein cholesterol concentration ≥100
- Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
Who cannot join
- Tobacco use
- Drug abuse
- Excessive alcohol consumption (>2 glasses of wine or alcohol equivalent per day for men or >1 glass of wine or alcohol equivalent for woman)
- Current cancer diagnosis
- Estimated glomerular filtration rate <60 mg/dL
- Clinically defined infection
Show all 9Show fewer
- Mental disability
- Hospitalization <6 months
- Previous exposure to plant-based diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors
This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.
Read the detailed description
Plant-based diets have emerged in the literature as effective therapeutic strategies in the reduction of body weight, serum lipids and blood pressure. In addition, raw fruit and vegetable consumption has also been associated with the reduction of these clinical indicators.
Participants were instructed to follow a prescribed, raw, plant-based dietary intervention for four weeks. All animal products, including eggs and dairy, were excluded. Cooked foods, free oils, soda, alcohol and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.
Participants came to a total of 4 follow-up visits. A laboratory panel was obtained at baseline and at 4-weeks. A 24-hour recall was also conducted at baseline and at 4-weeks. Anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.
- Conditions
- Hypertension, Elevated Cholesterol, Overweight and Obesity
- Being tested
- Dietary Intervention
- Medical subject headings
- Hypertension, Hypercholesterolemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.
| Study group | Role | What they receive |
|---|---|---|
| Raw, plant-based diet | Experimental | A raw, plant-based diet was prescribed for 4 weeks. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits
Measured: Baseline, follow-up weeks 1-4
Change in serum low-density lipoprotein cholesterol (LDL)
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in blood pressure
Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits
Measured: Baseline, follow-up weeks 1-4
Secondary outcomes (10)
Change in heart rate
Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits
Measured: Baseline, follow-up weeks 1-4
Change in waist circumference
Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits
Measured: Baseline, follow-up weeks 1-4
Change in serum total cholesterol
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum high-density lipoprotein cholesterol
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum triglycerides
Triglycerides mg/dL was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum insulin
Insulin (uU/mL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum glucose
Serum glucose (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum hemoglobin A1c (HgA1c)
HgA1c (%) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in c-reactive protein (CRP)
CRP (mg/L) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in medication use
Medication needs were assessed weekly
Measured: Baseline, follow-up weeks 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start3 Jan 2017
- Primary completion8 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures, single group design.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Montgomery Heart & Wellness
- Responsible party
- Principal investigator, Rami Najjar, Texas Woman's University
- Investigators
- Rami Najjar, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134235
- Sponsor's protocol ID
- 19279
- Status last verified
- May 2017
- First submitted
- 26 Apr 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.
PubMed 16873779Bazzano LA. Effects of soluble dietary fiber on low-density lipoprotein cholesterol and coronary heart disease risk. Curr Atheroscler Rep. 2008 Dec;10(6):473-7. doi: 10.1007/s11883-008-0074-3.
PubMed 18937894Bloomer RJ, Kabir MM, Canale RE, Trepanowski JF, Marshall KE, Farney TM, Hammond KG. Effect of a 21 day Daniel Fast on metabolic and cardiovascular disease risk factors in men and women. Lipids Health Dis. 2010 Sep 3;9:94. doi: 10.1186/1476-511X-9-94.
PubMed 20815907Boeing H, Bechthold A, Bub A, Ellinger S, Haller D, Kroke A, Leschik-Bonnet E, Muller MJ, Oberritter H, Schulze M, Stehle P, Watzl B. Critical review: vegetables and fruit in the prevention of chronic diseases. Eur J Nutr. 2012 Sep;51(6):637-63. doi: 10.1007/s00394-012-0380-y. Epub 2012 Jun 9.
PubMed 22684631Djousse L, Arnett DK, Coon H, Province MA, Moore LL, Ellison RC. Fruit and vegetable consumption and LDL cholesterol: the National Heart, Lung, and Blood Institute Family Heart Study. Am J Clin Nutr. 2004 Feb;79(2):213-7. doi: 10.1093/ajcn/79.2.213.
PubMed 14749225Fraser G, Katuli S, Anousheh R, Knutsen S, Herring P, Fan J. Vegetarian diets and cardiovascular risk factors in black members of the Adventist Health Study-2. Public Health Nutr. 2015 Feb;18(3):537-45. doi: 10.1017/S1368980014000263. Epub 2014 Mar 17.
PubMed 24636393Jenkins DJ, Kendall CW, Popovich DG, Vidgen E, Mehling CC, Vuksan V, Ransom TP, Rao AV, Rosenberg-Zand R, Tariq N, Corey P, Jones PJ, Raeini M, Story JA, Furumoto EJ, Illingworth DR, Pappu AS, Connelly PW. Effect of a very-high-fiber vegetable, fruit, and nut diet on serum lipids and colonic function. Metabolism. 2001 Apr;50(4):494-503. doi: 10.1053/meta.2001.21037.
PubMed 11288049Koebnick C, Garcia AL, Dagnelie PC, Strassner C, Lindemans J, Katz N, Leitzmann C, Hoffmann I. Long-term consumption of a raw food diet is associated with favorable serum LDL cholesterol and triglycerides but also with elevated plasma homocysteine and low serum HDL cholesterol in humans. J Nutr. 2005 Oct;135(10):2372-8. doi: 10.1093/jn/135.10.2372.
PubMed 16177198Le LT, Sabate J. Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. Nutrients. 2014 May 27;6(6):2131-47. doi: 10.3390/nu6062131.
PubMed 24871675Macknin M, Kong T, Weier A, Worley S, Tang AS, Alkhouri N, Golubic M. Plant-based, no-added-fat or American Heart Association diets: impact on cardiovascular risk in obese children with hypercholesterolemia and their parents. J Pediatr. 2015 Apr;166(4):953-9.e1-3. doi: 10.1016/j.jpeds.2014.12.058. Epub 2015 Feb 12.
PubMed 25684089Mishra S, Xu J, Agarwal U, Gonzales J, Levin S, Barnard ND. A multicenter randomized controlled trial of a plant-based nutrition program to reduce body weight and cardiovascular risk in the corporate setting: the GEICO study. Eur J Clin Nutr. 2013 Jul;67(7):718-24. doi: 10.1038/ejcn.2013.92. Epub 2013 May 22.
PubMed 23695207Ras RT, Geleijnse JM, Trautwein EA. LDL-cholesterol-lowering effect of plant sterols and stanols across different dose ranges: a meta-analysis of randomised controlled studies. Br J Nutr. 2014 Jul 28;112(2):214-9. doi: 10.1017/S0007114514000750. Epub 2014 Apr 29.
PubMed 24780090Turner-McGrievy GM, Barnard ND, Scialli AR. A two-year randomized weight loss trial comparing a vegan diet to a more moderate low-fat diet. Obesity (Silver Spring). 2007 Sep;15(9):2276-81. doi: 10.1038/oby.2007.270.
PubMed 17890496Wu L, Sun D, He Y. Fruit and vegetables consumption and incident hypertension: dose-response meta-analysis of prospective cohort studies. J Hum Hypertens. 2016 Oct;30(10):573-80. doi: 10.1038/jhh.2016.44. Epub 2016 Jun 16.
PubMed 27306085Yokoyama Y, Nishimura K, Barnard ND, Takegami M, Watanabe M, Sekikawa A, Okamura T, Miyamoto Y. Vegetarian diets and blood pressure: a meta-analysis. JAMA Intern Med. 2014 Apr;174(4):577-87. doi: 10.1001/jamainternmed.2013.14547.
PubMed 24566947
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT03134235
- Acronym / sponsor ID
- 19279
- Conditions
- Hypertension, Elevated Cholesterol, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Montgomery Heart & Wellness
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- 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.
This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.
Detailed description
Plant-based diets have emerged in the literature as effective therapeutic strategies in the reduction of body weight, serum lipids and blood pressure. In addition, raw fruit and vegetable consumption has also been associated with the reduction of these clinical indicators.
Participants were instructed to follow a prescribed, raw, plant-based dietary intervention for four weeks. All animal products, including eggs and dairy, were excluded. Cooked foods, free oils, soda, alcohol and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.
Participants came to a total of 4 follow-up visits. A laboratory panel was obtained at baseline and at 4-weeks. A 24-hour recall was also conducted at baseline and at 4-weeks. Anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures, single group design.
| Arm | Type | Receives |
|---|---|---|
| Raw, plant-based diet | Experimental | Other: Dietary InterventionA raw, plant-based diet was prescribed for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index ≥25.0 kg/m^2
- Serum low-density lipoprotein cholesterol concentration ≥100
- Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
Key exclusion criteria (9 listed)
- Tobacco use
- Drug abuse
- Excessive alcohol consumption (>2 glasses of wine or alcohol equivalent per day for men or >1 glass of wine or alcohol equivalent for woman)
- Current cancer diagnosis
- Estimated glomerular filtration rate <60 mg/dL
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 |
|---|---|---|
| Dietary InterventionSubjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption. | Other | Raw, plant-based diet |
Primary outcome
Change in body weight
Time frame: Baseline, follow-up weeks 1-4
Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits
Change in serum low-density lipoprotein cholesterol (LDL)
Time frame: Baseline and 4-weeks
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Change in blood pressure
Time frame: Baseline, follow-up weeks 1-4
Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits
10 secondary outcomes
Change in heart rate
Time frame: Baseline, follow-up weeks 1-4
Change in waist circumference
Time frame: Baseline, follow-up weeks 1-4
Change in serum total cholesterol
Time frame: Baseline and 4-weeks
Change in serum high-density lipoprotein cholesterol
Time frame: Baseline and 4-weeks
Change in serum triglycerides
Time frame: Baseline and 4-weeks
Change in serum insulin
Time frame: Baseline and 4-weeks
Change in serum glucose
Time frame: Baseline and 4-weeks
Change in serum hemoglobin A1c (HgA1c)
Time frame: Baseline and 4-weeks
Change in c-reactive protein (CRP)
Time frame: Baseline and 4-weeks
Change in medication use
Time frame: Baseline, follow-up weeks 1-4
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 23 May 2017.
- Background: PubMed 16873779Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.
- Background: PubMed 18937894Bazzano LA. Effects of soluble dietary fiber on low-density lipoprotein cholesterol and coronary heart disease risk. Curr Atheroscler Rep. 2008 Dec;10(6):473-7. doi: 10.1007/s11883-008-0074-3.
- Background: PubMed 20815907Bloomer RJ, Kabir MM, Canale RE, Trepanowski JF, Marshall KE, Farney TM, Hammond KG. Effect of a 21 day Daniel Fast on metabolic and cardiovascular disease risk factors in men and women. Lipids Health Dis. 2010 Sep 3;9:94. doi: 10.1186/1476-511X-9-94.
- Background: PubMed 22684631Boeing H, Bechthold A, Bub A, Ellinger S, Haller D, Kroke A, Leschik-Bonnet E, Muller MJ, Oberritter H, Schulze M, Stehle P, Watzl B. Critical review: vegetables and fruit in the prevention of chronic diseases. Eur J Nutr. 2012 Sep;51(6):637-63. doi: 10.1007/s00394-012-0380-y. Epub 2012 Jun 9.
- Background: PubMed 14749225Djousse L, Arnett DK, Coon H, Province MA, Moore LL, Ellison RC. Fruit and vegetable consumption and LDL cholesterol: the National Heart, Lung, and Blood Institute Family Heart Study. Am J Clin Nutr. 2004 Feb;79(2):213-7. doi: 10.1093/ajcn/79.2.213.
- Background: PubMed 24636393Fraser G, Katuli S, Anousheh R, Knutsen S, Herring P, Fan J. Vegetarian diets and cardiovascular risk factors in black members of the Adventist Health Study-2. Public Health Nutr. 2015 Feb;18(3):537-45. doi: 10.1017/S1368980014000263. Epub 2014 Mar 17.
- Background: PubMed 11288049Jenkins DJ, Kendall CW, Popovich DG, Vidgen E, Mehling CC, Vuksan V, Ransom TP, Rao AV, Rosenberg-Zand R, Tariq N, Corey P, Jones PJ, Raeini M, Story JA, Furumoto EJ, Illingworth DR, Pappu AS, Connelly PW. Effect of a very-high-fiber vegetable, fruit, and nut diet on serum lipids and colonic function. Metabolism. 2001 Apr;50(4):494-503. doi: 10.1053/meta.2001.21037.
- Background: PubMed 16177198Koebnick C, Garcia AL, Dagnelie PC, Strassner C, Lindemans J, Katz N, Leitzmann C, Hoffmann I. Long-term consumption of a raw food diet is associated with favorable serum LDL cholesterol and triglycerides but also with elevated plasma homocysteine and low serum HDL cholesterol in humans. J Nutr. 2005 Oct;135(10):2372-8. doi: 10.1093/jn/135.10.2372.
- Background: PubMed 24871675Le LT, Sabate J. Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. Nutrients. 2014 May 27;6(6):2131-47. doi: 10.3390/nu6062131.
- Background: PubMed 25684089Macknin M, Kong T, Weier A, Worley S, Tang AS, Alkhouri N, Golubic M. Plant-based, no-added-fat or American Heart Association diets: impact on cardiovascular risk in obese children with hypercholesterolemia and their parents. J Pediatr. 2015 Apr;166(4):953-9.e1-3. doi: 10.1016/j.jpeds.2014.12.058. Epub 2015 Feb 12.
- Background: PubMed 23695207Mishra S, Xu J, Agarwal U, Gonzales J, Levin S, Barnard ND. A multicenter randomized controlled trial of a plant-based nutrition program to reduce body weight and cardiovascular risk in the corporate setting: the GEICO study. Eur J Clin Nutr. 2013 Jul;67(7):718-24. doi: 10.1038/ejcn.2013.92. Epub 2013 May 22.
- Background: PubMed 24780090Ras RT, Geleijnse JM, Trautwein EA. LDL-cholesterol-lowering effect of plant sterols and stanols across different dose ranges: a meta-analysis of randomised controlled studies. Br J Nutr. 2014 Jul 28;112(2):214-9. doi: 10.1017/S0007114514000750. Epub 2014 Apr 29.
- Individual participant dataSharing planned: No
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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.
Rami Najjar principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Hypertension and Elevated Cholesterol, run by Texas Woman's University at 1 site in United States.
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 9 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in body weight (time frame: Baseline, follow-up weeks 1-4). The study lists 3 primary outcomes in all. 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 NCT03134235, which also lists 15 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 23 May 2017.