Trial Outcomes & Findings for Clinical Trial of Dietary Protein and Blood Pressure (NCT NCT00046566)
NCT ID: NCT00046566
Last Updated: 2017-07-24
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 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.
COMPLETED
NA
352 participants
Every 8 weeks
2017-07-24
Participant Flow
Participant milestones
| Measure |
Soy Protein-milk Protein-carbohydrate Group
117 participants assigned to soy protein-milk protein-carbohydrate group. They received 40 g/d soy protein for 8 weeks, then 40 g/d milk protein for 8 weeks, and finally 40 g/d carbohydrate for 8 weeks.
|
Milk Protein-carbohydrate-soy Protein Group
117 participants assigned to milk protein-carbohydrate-soy protein group. They received 40 g/d milk protein for 8 weeks, then 40 g/d carbohydrate for 8 weeks, and finally 40 g/d soy protein for 8 weeks.
|
Carbohydrate-soy Protein-milk Protein Group
118 participants assigned to carbohydrate-soy protein-milk protein group. They received 40 g/d carbohydrate for 8 weeks, then 40 g/d soy protein for 8 weeks, and finally 40 g/d milk protein 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 Dietary Protein and Blood Pressure
Baseline characteristics by cohort
| Measure |
Soy Protein-milk-protein-carbohydrate
n=117 Participants
Soy protein-milk-protein-carbohydrate group
|
Milk Protein-carbohydrate-soy Protein
n=117 Participants
Milk protein-carbohydrate-soy protein group
|
Carbohydrate-soy Protein-milk Protein
n=118 Participants
Carbohydrate-soy protein-milk protein group
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
46.7 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
48.1 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
47.7 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
205 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
147 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=99 Participants
|
117 participants
n=107 Participants
|
118 participants
n=206 Participants
|
352 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeksPopulation: participants took soy protein during three phases
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.
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: Every 8 weeksPopulation: Participants took soy protein for 8 weeks
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
| 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: Every 8 weeksPopulation: Participants took supplementation for 8 weeks
Body weight was measured by trained staff using a standard protocol at week 8.
Outcome measures
| Measure |
Soy Protein Supplementation
n=310 Participants
Cross-over analysis of soy protein supplementation
|
Milk Protein Supplementation
n=306 Participants
Cross-over analysis of milk protein supplementation
|
Carbohydrate Supplementation
n=315 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
Milk Protein Supplementation
Carbohydrate Supplementation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place