Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors

NCT03134235 | Completed

• 1 other identifier: 19279
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Elevated Cholesterol; Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• Change in body weight

  Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits

  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

  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

  Baseline, follow-up weeks 1-4

Secondary Outcomes (10)

• Change in heart rate

  Baseline, follow-up weeks 1-4

• Change in waist circumference

  Baseline, follow-up weeks 1-4

• Change in serum total cholesterol

  Baseline and 4-weeks

• Change in serum high-density lipoprotein cholesterol

  Baseline and 4-weeks

• Change in serum triglycerides

  Baseline and 4-weeks

Study Arms (1)

Raw, plant-based diet

EXPERIMENTAL

A raw, plant-based diet was prescribed for 4 weeks.

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.

Raw, plant-based diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Mental disability
• Hospitalization \<6 months
• Previous exposure to plant-based diet

Sponsors & Collaborators

• Texas Woman's University: lead
• Montgomery Heart & Wellness: collaborator

Study Sites (1)

Montgomery Heart & Wellness

Houston, Texas, 77025, United States

Location

Related Publications (15)

• 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.

  PMID: 16873779 BACKGROUND

• Bazzano 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.

  PMID: 18937894 BACKGROUND

• Bloomer 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.

  PMID: 20815907 BACKGROUND

• Boeing 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.

  PMID: 22684631 BACKGROUND

• Djousse 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.

  PMID: 14749225 BACKGROUND

• Fraser 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.

  PMID: 24636393 BACKGROUND

• Jenkins 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.

  PMID: 11288049 BACKGROUND

• Koebnick 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.

  PMID: 16177198 BACKGROUND

• Le 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.

  PMID: 24871675 BACKGROUND

• Macknin 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.

  PMID: 25684089 BACKGROUND

• Mishra 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.

  PMID: 23695207 BACKGROUND

• Ras 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.

  PMID: 24780090 BACKGROUND

• Turner-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.

  PMID: 17890496 BACKGROUND

• Wu 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.

  PMID: 27306085 BACKGROUND

• Yokoyama 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.

  PMID: 24566947 BACKGROUND

MeSH Terms

Conditions

Hypertension; Hypercholesterolemia; Overweight; Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Rami Najjar

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: Repeated measures, single group design.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: April 28, 2017
• Study Start: January 3, 2017
• Primary Completion: March 8, 2017
• Study Completion: March 15, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)