An interventional study of Soy protein-milk protein-carbohydrate and Milk protein-carbohydrate-soy protein in Hypertension and Hypercholesterolemia, sponsored by Tulane University. Completed. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Tulane University · Not applicable, Interventional, and Prevention
The purpose of this randomized, double-blind, controlled trial is to examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension.
Background: Epidemiologic studies suggest that vegetable protein intake is inversely related to blood pressure.
Objectives: To examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension
Design: Randomized, double-blind, controlled trial
Study Participants: 350 participants, aged 35-64 years, with an initial untreated systolic blood pressure of 130-159 mmHg and/or diastolic blood pressure of 80-99 mmHg
Intervention: Study participants will be randomly assigned to take 40-grams of isolated soybean protein supplements per day or complex carbohydrate control for 12 weeks.
Outcomes: Blood pressure measurements will be obtained using random-zero sphygmomanometers at baseline and during the trial at weeks 6 and 12. Net changes in systolic and diastolic blood pressure before and after the intervention is the primary outcome.
1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.
This study's enrollment of 352 is above the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Tulane University is the lead sponsor of 98 studies on the registry; 30 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Dietary Supplement: Carbohydrate-soy protein-milk protein
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
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.
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.
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 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.
Time frame: Baseline and 8 Weeks
Change From Baseline in Serum LDL-cholesterol at 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.
Time frame: Baseline and 8 Weeks
Body Weight at 8 Weeks
Body weight was measured by trained staff using a standard protocol at week 8.
Time frame: Baseline and 8 Weeks
| Milestone | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein |
|---|---|---|---|
| Started | 117 | 117 | 118 |
| Completed | 101 | 104 | 101 |
| Not completed | 16 | 13 | 17 |
| Milestone | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein |
|---|---|---|---|
| Started | 101 | 104 | 101 |
| Completed | 93 | 92 | 88 |
| Not completed | 8 | 12 | 13 |
| Milestone | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein |
|---|---|---|---|
| Started | 93 | 92 | 88 |
| Completed | 93 | 92 | 88 |
| Not completed | 0 | 0 | 0 |
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.
| mmHg | Soy Protein Supplementation | Milk Protein Supplementation | Carbohydrate Supplementation |
|---|---|---|---|
| Change From Baseline in Average Systolic Blood Pressure at 8 Weeks | -1.5 (-2.4 to -0.6) | -1.8 (-2.7 to -1.0) | 0.5 (-0.4 to 1.3) |
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.
| mg/dL | Soy Protein Supplementation | Milk Protein Supplementation | Carbohydrate Supplementation |
|---|---|---|---|
| Change From Baseline in Serum LDL-cholesterol at 8 Weeks | -3.97 (-7.63 to -0.31) | -2.56 (-5.40 to 0.28) | -1.41 (-4.24 to 1.42) |
Body weight was measured by trained staff using a standard protocol at week 8.
| kg | Soy Protein Supplementation | Milk Protein Supplementation | Carbohydrate Supplementation |
|---|---|---|---|
| Body Weight at 8 Weeks | 86.2 (84.4 to 88.0) | 86.6 (84.9 to 88.4) | 86.7 (84.9 to 88.5) |
Collected over Through study completion, an average of 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Soy Protein Supplementation | 0/352 (0%) | 0/352 (0%) | 0/352 (0%) |
| Milk Protein Supplementation | 0/352 (0%) | 0/352 (0%) | 0/352 (0%) |
| Carbohydrate Supplementation | 0/352 (0%) | 0/352 (0%) | 0/352 (0%) |
Participants randomized to this three-phase cross-over trial.
| Age, Continuous(years) | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein | Total |
|---|---|---|---|---|
| Mean | 48.4 ± 11.5 | 46.7 ± 10.7 | 48.1 ± 8.7 | 47.7 ± 10.3 |
| Sex: Female, Male(Participants) | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein | Total |
|---|---|---|---|---|
| Female | 48 | 49 | 50 | 147 |
| Male | 69 | 68 | 68 | 205 |
| Race (NIH/OMB)(Participants) | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 39 | 38 | 44 | 121 |
| White | 78 | 79 | 74 | 231 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein | Total |
|---|---|---|---|---|
| United States | 117 | 117 | 118 | 352 |
| Systolic Blood Pressure(mmHg) | Soy Protein-milk Protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein | Total |
|---|---|---|---|---|
| Mean | 127.2 ± 9.3 | 126.7 ± 11.0 | 126.1 ± 9.7 | 126.7 ± 10.0 |
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Tulane University