Glycomacropeptide and Women's Health

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: glycomacropeptide (GMP)

• Registration Number: NCT05551091
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2019-04-09
• Primary Completion: 2022-07-05
• Study Completion: 2022-07-05
• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GMP 25 mg BID	glycomacropeptide (GMP)	Investigators will conduct a pilot cross-over study in which 13 obese participants undergo measures of study outcomes: satiety hormones, glucose, amino acid and cytokine levels and changes in the fecal microbiota at baseline and after 7 days of consuming the supplement. On day one participants will consume a liquid soy breakfast, undergo study measures and then initiate GMP supplements twice a day (BID) x 7 days, with repeat study measures on day 7 of consuming the GMP supplement.
GMP 25 mg TID	glycomacropeptide (GMP)	After a washout period, the same 13 participants will undergo repeated measures of study outcomes (satiety hormones, glucose, amino acid and cytokine levels and changes in the fecal microbiota). On day one subjects will consume a liquid soy breakfast, undergo study measures and then initiate GMP supplements thrice a day (TID) x 7 days, with repeat study measures on day 7 of consuming the GMP supplement.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States