Glycomacropeptide and Women's Health

Obesity Clinical Trial

— GMP  

Official title:

Glycomacropeptide as a Protein Supplement to Curb Hunger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551091
• Other study ID #: 2018-1261
• Secondary ID: A074600AG&LSC/NU
• Status: Completed
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: July 5, 2022

Study information

• Verified date: September 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 5, 2022
• Est. primary completion date: July 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• glycomacropeptide (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).

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose homeostasis	Difference in glucose area under the curve after a soy versus a GMP liquid breakfast	glucose levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial
Secondary	Ghrelin, a hormone regulating hunger and satiety	Difference in ghrelin area under the curve after a soy versus a GMP liquid breakfast	ghrelin levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial