Trial Outcomes & Findings for Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women (NCT NCT02375113)
NCT ID: NCT02375113
Last Updated: 2024-05-10
Results Overview
Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Study endpoint (6 months post intervention)
Results posted on
2024-05-10
Participant Flow
This was a six-month randomized double-blind, placebo-controlled trial. Subjects, early post-menopausal women, were recruited from the local community via flyers, bulletin board advertisements and word-of-mouth referrals. Subjects were randomly assigned to either the Intervention group or the Control group .
Participant milestones
| Measure |
Intervention
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Intervention
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Overall Study
Undisclosed Reason(s).
|
1
|
1
|
|
Overall Study
Poor adherence (<70%).
|
1
|
0
|
|
Overall Study
Discomfort of ingesting daily protein sh
|
0
|
1
|
Baseline Characteristics
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
Baseline characteristics by cohort
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 4 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA)
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Body Fat (kg)
Total body fat (kg)
|
40.96 kg
Standard Error 0.84
|
40.12 kg
Standard Error 0.97
|
|
Body Fat (kg)
Abdominal fat (kg)
|
2.94 kg
Standard Error 0.57
|
4.26 kg
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
Body Mass Index (BMI) was calculated using the equation of weight (kg) over height (m) squared (kg/m\^2)
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
BMI (kg/m^2)
|
33.45 kg/m^2
Standard Error 0.5
|
33.64 kg/m^2
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
Subjects' resting systolic and diastolic blood pressure (SBP and DBP, mmHg) was measured with an electronic sphygmomanometer (Omron, USA).
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Blood Pressure (mmHg)
SBP (mm Hg)
|
125.41 mm Hg
Standard Error 6.11
|
129.99 mm Hg
Standard Error 6.64
|
|
Blood Pressure (mmHg)
DBP (mm Hg)
|
73.06 mm Hg
Standard Error 3.42
|
74.61 mm Hg
Standard Error 3.55
|
SECONDARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
High-density lipoprotein (HDL) (mg/L) normal range \> 40 mg/dL Low-density lipoprotein (LDL) (mg/L) normal range \<100 mg/dL Triglyceride (TG) (mg/L) normal range \<150 mg/dl Fasting glucose (mg/dl) normal range: \<100 mg/dl C-Reactive Protein (mg/dl): \<3 mg/dl in healthy individuals
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Lipid Profile and Fasting Glucose
TC (mg/dl)
|
171.38 mg/dl
Standard Error 3.45
|
175.16 mg/dl
Standard Error 3.33
|
|
Lipid Profile and Fasting Glucose
HDL (mg/dl)
|
53.69 mg/dl
Standard Error 3.13
|
47.66 mg/dl
Standard Error 3.04
|
|
Lipid Profile and Fasting Glucose
LDL (mg/dl)
|
98.98 mg/dl
Standard Error 6.42
|
106.9 mg/dl
Standard Error 6.06
|
|
Lipid Profile and Fasting Glucose
TG (mg/dl)
|
114.05 mg/dl
Standard Error 3.09
|
104.98 mg/dl
Standard Error 3.19
|
|
Lipid Profile and Fasting Glucose
Glucose (mg/dl)
|
85.98 mg/dl
Standard Error 2.08
|
89.47 mg/dl
Standard Error 2.19
|
SECONDARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
Waist Circumference was measured midway between the iliac crest and bottom of the rib cage (cm)
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Waist Circumference (cm)
|
105.59 cm
Standard Error 0.3
|
107.24 cm
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
Insulin sensitivity index as measured by homeostasis model assessment-insulin resistance (HOMA-IR Index): Normal range 0.5-1.4
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Insulin Resistance
|
1.62 HOMA-IR Index
Standard Error 0.42
|
1.62 HOMA-IR Index
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
Inflammatory cytokines IL-6 (ng/ml): 75-80 ng/ml in healthy individuals
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Inflammatory Cytokines IL-6 (ng/ml)
|
0.1 ng/ml
Standard Error 0.05
|
0.04 ng/ml
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Study endpoint (6 months post intervention)Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
C-Reactive Protein (mg/L) \<3 mg/L in healthy individuals
Outcome measures
| Measure |
Intervention
n=4 Participants
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=4 Participants
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
C-Reactive Protein (mg/L)
|
3.11 mg/L
Standard Error 0.04
|
3.08 mg/L
Standard Error 0.05
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=6 participants at risk
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
Control
n=6 participants at risk
Placebo capsules + 25 gram whey protein / day
soy supplementation: Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
|
|---|---|---|
|
Gastrointestinal disorders
Discomfort of ingesting daily protein shake
|
0.00%
0/6 • The data and adverse effect was monitored from the start of the 6-month period to the end.
|
16.7%
1/6 • Number of events 1 • The data and adverse effect was monitored from the start of the 6-month period to the end.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place