Obesity
Conditions
Keywords
obesity, glucose tolerance, satiety, hunger, microbiome, amino acids, C-reactive protein
Brief summary
This is a study about how a dietary supplement containing a whey protein affects hormones controlling hunger and satiety (leptin and ghrelin) in postmenopausal women with a body mass index between 28 and 35 kg/m2. Participants can expect to be in study for 4 weeks.
Detailed description
The purpose of this research study is to understand how a dietary supplement containing glycomacropeptide (GMP) affects blood sugar levels and hormones that regulate hunger and satiety. This study is being conducted to find new ways to help women lose weight and reduce their chance of getting diabetes.
Interventions
DIETARY_SUPPLEMENTglycomacropeptide (GMP)
For each of the two baseline visits, women will consume a 300 calorie liquid breakfast meal tolerance test (MTT), eat a standard test lunch ad libitum with recording of food intake, and will then begin the low-dose GMP (25 g BID with meals) or high-dose GMP (25 g TID with meals) for 7 days. On day 7 of each GMP diet, women will come to the Clinical Research Unit (CRU) for a second breakfast MTT followed by lunch. All subjects will stop GMP products for 5-7 days (washout).
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants underwent measures of study outcomes at 4 time points: day 1 and day 7 of consuming GMP supplements twice daily (low-dose, 25 g before breakfast and dinner) and day 1 and day 7 of consuming GMP supplements thrice daily (high-dose, 25 g before breakfast, lunch and dinner). For each of the two baseline visits (day 1), participants consumed 300 kcal liquid breakfast meal tolerance test containing soy protein isolate, and then began the low-dose GMP or high-dose GMP for 7 days. On day 7 of each GMP diet, participants returned for a second GMP-based 300 kcal liquid breakfast meal tolerance test. Between the 2 weeks of GMP consumption, participants had a minimum washout period of 5 days.
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* no more than 10 years past menopause as defined by the date of last menses, less than 90 years old, BMI of 28 to 35 kg/m2.
Exclusion criteria
* BMI\>35 kg/m2, diabetes, and/or an active medical problem or condition that would interfere with study outcomes (malignancy, inflammatory condition, gastric bypass surgery or participation in another study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose homeostasis | glucose levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial | Difference in glucose area under the curve after a soy versus a GMP liquid breakfast |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ghrelin, a hormone regulating hunger and satiety | ghrelin levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial | Difference in ghrelin area under the curve after a soy versus a GMP liquid breakfast |
Countries
United States
Outcome results
None listed