Trial Outcomes & Findings for Clinical Trial of Protein and Blood Pressure (NCT NCT00107744)

Last Updated: 2023-04-12

Results Overview

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 2 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

352 participants

Primary outcome timeframe

Baseline and 8 Weeks

Results posted on

2023-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Soy Protein-milk Protein-carbohydrate 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.	Milk Protein-carbohydrate-soy Protein 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.	Carbohydrate-soy Protein-milk Protein 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.
Intervention 1 (8 Weeks) STARTED	117	117	118
Intervention 1 (8 Weeks) COMPLETED	101	104	101
Intervention 1 (8 Weeks) NOT COMPLETED	16	13	17
Intervention 2 (8 Weeks) STARTED	101	104	101
Intervention 2 (8 Weeks) COMPLETED	93	92	88
Intervention 2 (8 Weeks) NOT COMPLETED	8	12	13
Intervention 3 (8 Weeks) STARTED	93	92	88
Intervention 3 (8 Weeks) COMPLETED	93	92	88
Intervention 3 (8 Weeks) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of Protein and Blood Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Soy Protein-milk Protein-carbohydrate n=117 Participants 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.	Milk Protein-carbohydrate-soy Protein n=117 Participants 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.	Carbohydrate-soy Protein-milk Protein n=118 Participants 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.	Total n=352 Participants Total of all reporting groups
Age, Continuous	48.4 years STANDARD_DEVIATION 11.5 • n=5 Participants	46.7 years STANDARD_DEVIATION 10.7 • n=7 Participants	48.1 years STANDARD_DEVIATION 8.7 • n=5 Participants	47.7 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	49 Participants n=7 Participants	50 Participants n=5 Participants	147 Participants n=4 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	68 Participants n=7 Participants	68 Participants n=5 Participants	205 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	39 Participants n=5 Participants	38 Participants n=7 Participants	44 Participants n=5 Participants	121 Participants n=4 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants	79 Participants n=7 Participants	74 Participants n=5 Participants	231 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	117 participants n=5 Participants	117 participants n=7 Participants	118 participants n=5 Participants	352 participants n=4 Participants
Systolic Blood Pressure	127.2 mmHg STANDARD_DEVIATION 9.3 • n=5 Participants	126.7 mmHg STANDARD_DEVIATION 11.0 • n=7 Participants	126.1 mmHg STANDARD_DEVIATION 9.7 • n=5 Participants	126.7 mmHg STANDARD_DEVIATION 10.0 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 8 Weeks

Population: We conducted analysis according to intention-to-treat principle. All participants with data were included in analysis.

Outcome measures

Outcome measures
Measure	Soy Protein Supplementation n=284 Participants Cross-over analysis of soy protein supplementation	Milk Protein Supplementation n=286 Participants Cross-over analysis of milk protein supplementation	Carbohydrate Supplementation n=287 Participants Cross-over analysis of milk protein supplementation
Change From Baseline in Average Systolic Blood Pressure at 8 Weeks	-1.5 mmHg Interval -2.4 to -0.6	-1.8 mmHg Interval -2.7 to -1.0	0.5 mmHg Interval -0.4 to 1.3

SECONDARY outcome

Timeframe: Baseline and 8 Weeks

Population: All participants with lipid data

Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method.

Outcome measures

Outcome measures
Measure	Soy Protein Supplementation n=284 Participants Cross-over analysis of soy protein supplementation	Milk Protein Supplementation n=286 Participants Cross-over analysis of milk protein supplementation	Carbohydrate Supplementation n=287 Participants Cross-over analysis of milk protein supplementation
Change From Baseline in Serum LDL-cholesterol at 8 Weeks	-3.97 mg/dL Interval -7.63 to -0.31	-2.56 mg/dL Interval -5.4 to 0.28	-1.41 mg/dL Interval -4.24 to 1.42

SECONDARY outcome

Timeframe: Baseline and 8 Weeks

Population: All participants with body weight measures at each intervention phase

Body weight was measured by trained staff using a standard protocol at week 8.

Outcome measures

Outcome measures
Measure	Soy Protein Supplementation n=284 Participants Cross-over analysis of soy protein supplementation	Milk Protein Supplementation n=286 Participants Cross-over analysis of milk protein supplementation	Carbohydrate Supplementation n=287 Participants Cross-over analysis of milk protein supplementation
Body Weight at 8 Weeks	86.2 kg Interval 84.4 to 88.0	86.6 kg Interval 84.9 to 88.4	86.7 kg Interval 84.9 to 88.5

Adverse Events

Soy Protein Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Milk Protein Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carbohydrate Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jiang He, MD, PhD, Chair of Epidemiology

Tulane University

Phone: 504-988-5165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place