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

Hypertension Clinical Trial

Official title:

A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134235
• Other study ID #: 19279
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: May 19, 2017
• Start date: January 3, 2017
• Est. completion date: March 15, 2017

Study information

• Verified date: May 2017
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 15, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Elevated Cholesterol
• Hypercholesterolemia
• Hypertension
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Montgomery Heart & Wellness	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Woman's University	Montgomery Heart & Wellness

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Boeing H, Bechthold A, Bub A, Ellinger S, Haller D, Kroke A, Leschik-Bonnet E, Müller 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. Review. — View Citation

Djoussé 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Le LT, Sabaté 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits	Baseline, follow-up weeks 1-4
Primary	Change in serum low-density lipoprotein cholesterol (LDL)	LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Primary	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	Change in heart rate	Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits	Baseline, follow-up weeks 1-4
Secondary	Change in waist circumference	Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits	Baseline, follow-up weeks 1-4
Secondary	Change in serum total cholesterol	Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum high-density lipoprotein cholesterol	Serum HDL (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum triglycerides	Triglycerides mg/dL was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum insulin	Insulin (uU/mL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum glucose	Serum glucose (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum hemoglobin A1c (HgA1c)	HgA1c (%) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in c-reactive protein (CRP)	CRP (mg/L) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in medication use	Medication needs were assessed weekly	Baseline, follow-up weeks 1-4