Glycomacropeptide and Women's Health (GMP)

University of Wisconsin (UW)

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: glycomacropeptide (GMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05551091

A074600 (Other Identifier)

Protocol Version 8/11/2022 (Other Identifier)

AG&LSC/NUTRITIONAL SCI/NUTRIT (Other Identifier)

2018-1261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: Under 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

GMP 25 mg BID

Experimental group

Description:

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.

Treatment:

Dietary Supplement: glycomacropeptide (GMP)

GMP 25 mg TID

Experimental group

Description:

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.

Treatment:

Dietary Supplement: glycomacropeptide (GMP)