Clinical Trial of Dietary Protein and Blood Pressure

NCT00046566 | Completed Results DMC

• 2 other identifiers: 145R01HL068057
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of dietary protein supplements on high blood pressure (BP).

Conditions

Cardiovascular Diseases; Hypertension; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Average Systolic Blood Pressure at 8 Weeks

  The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from two baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.

  Every 8 weeks

Secondary Outcomes (2)

• Change From Baseline in Serum LDL-cholesterol at 8 Weeks

  Every 8 weeks

• Body Weight at 8 Weeks

  Every 8 weeks

Study Arms (3)

Soy protein-milk protein-carbohydrate

ACTIVE COMPARATOR

Participants received 40 grams of soy protein daily for 8 weeks, 40 grams of milk protein daily for 8 weeks, and 40 grams of carbohydrate daily for 8 weeks.

Dietary Supplement: Soy protein-milk protein-carbohydrate

Milk protein-carbohydrate-soy protein

EXPERIMENTAL

Participants received 40 grams of milk protein daily for 8 weeks, 40 grams of carbohydrate daily for 8 weeks, and 40 grams of soy protein daily for 8 weeks.

Dietary Supplement: Milk protein-carbohydrate-soy protein

Carbohydrate-soy protein-milk protein

PLACEBO COMPARATOR

Participants received 40 grams of complex carbohydrate daily for 8 weeks, 40 grams of soy protein daily for 8 weeks, and 40 grams of milk protein daily for 8 weeks.

Behavioral: Carbohydrate-soy protein-milk protein

Interventions

Soy protein-milk protein-carbohydrate DIETARY_SUPPLEMENT

40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks

Soy protein-milk protein-carbohydrate

Milk protein-carbohydrate-soy protein DIETARY_SUPPLEMENT

40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.

Milk protein-carbohydrate-soy protein

Carbohydrate-soy protein-milk protein BEHAVIORAL

40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks,

Carbohydrate-soy protein-milk protein

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systolic BP of 120 to 159 mm Hg and diastolic BP of 80 to 95 mm Hg (average of 6 measurements at 2 screening visits)
• Willing to participate in all aspects of the study

You may not qualify if:

• Consumption of dietary protein greater than or equal to 1.63 grams/kg per day, as determined by two 24-hour dietary recalls
• Stage-2 or higher severe hypertension (systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 95 mm Hg)
• Use of antihypertensive medications or medications that affect BP
• History of clinical heart disease (e.g., angina/heart attack, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
• Kidney disease (serum creatinine level greater than or equal to 1.7 mg/dL for men and greater than or equal to 1.5 mg/dL for women)
• Current hypercholesterolemia (fasting serum total cholesterol greater than or equal to 240 mg/dL) or use of cholesterol-lowering medications
• Current diabetes (fasting serum glucose greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
• Severe obesity (body mass index greater than or equal to 40 kg/m²)
• Current use of prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss greater than 15 pounds within the 6 months prior to study entry
• Cancer (except non-melanoma skin cancer) that required treatment during the year prior to study entry
• Consumption of more than 14 alcoholic beverages per week
• Current participation in another medical study
• Consumption of milk or soy protein greater than or equal to the 90th percentile of intake in the U.S. general population
• Has another member of the household participating in the study
• Study employees or living with study employees

Sponsors & Collaborators

• Tulane University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Related Publications (4)

• Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.

  PMID: 15652604 BACKGROUND

• Rebholz CM, Reynolds K, Wofford MR, Chen J, Kelly TN, Mei H, Whelton PK, He J. Effect of soybean protein on novel cardiovascular disease risk factors: a randomized controlled trial. Eur J Clin Nutr. 2013 Jan;67(1):58-63. doi: 10.1038/ejcn.2012.186. Epub 2012 Nov 28.

  PMID: 23187956 BACKGROUND

• He J, Wofford MR, Reynolds K, Chen J, Chen CS, Myers L, Minor DL, Elmer PJ, Jones DW, Whelton PK. Effect of dietary protein supplementation on blood pressure: a randomized, controlled trial. Circulation. 2011 Aug 2;124(5):589-95. doi: 10.1161/CIRCULATIONAHA.110.009159. Epub 2011 Jul 18.

  PMID: 21768541 RESULT

• Wofford MR, Rebholz CM, Reynolds K, Chen J, Chen CS, Myers L, Xu J, Jones DW, Whelton PK, He J. Effect of soy and milk protein supplementation on serum lipid levels: a randomized controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):419-25. doi: 10.1038/ejcn.2011.168. Epub 2011 Sep 28.

  PMID: 21952693 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Heart Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Jiang He, MD, PhD, Chair of Epidemiology
• Organization: Tulane University

jhe@tulane.edu

5049885165

Study Officials

• Jiang He, MD

  Tulane University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization assignment list was generated by a computer program that could only be accessed by the study data coordinator. Apart from the data coordinator, all research personnel, including study coordinators and BP technicians, and the study participants were unaware of treatment assignment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Model Details: The trial participants were assigned to take 40 g/d soy protein, milk protein, or carbohydrate supplementation each for 8 weeks in a random order. A 3-week washout period was implemented between the interventions.

Study Record Dates

• First Submitted: September 30, 2002
• First Posted: October 1, 2002
• Study Start: July 1, 2002
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)