Glycomacropeptide and Women's Health

NCT05551091 | Completed

• 4 other identifiers: 2018-1261A074600AG&LSC/NUTRITIONAL SCI/NUTRITProtocol Version 8/11/2022
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; glucose tolerance; satiety; hunger; microbiome; amino acids; C-reactive protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ghrelin, a hormone regulating hunger and satiety

  ghrelin levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial

Study Arms (2)

GMP 25 mg BID

EXPERIMENTAL

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.

Dietary Supplement: glycomacropeptide (GMP)

GMP 25 mg TID

EXPERIMENTAL

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.

Dietary Supplement: glycomacropeptide (GMP)

Interventions

glycomacropeptide (GMP) DIETARY_SUPPLEMENT

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).

GMP 25 mg BID; GMP 25 mg TID

Eligibility Criteria

• Age: Up to 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• Hansen KE, Murali S, Chaves IZ, Suen G, Ney DM. Glycomacropeptide Impacts Amylin-Mediated Satiety, Postprandial Markers of Glucose Homeostasis, and the Fecal Microbiome in Obese Postmenopausal Women. J Nutr. 2023 Jul;153(7):1915-1929. doi: 10.1016/j.tjnut.2023.03.014. Epub 2023 Apr 26.

  PMID: 37116657 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

caseinomacropeptide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen E Hansen, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: April 9, 2019
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: within 3 months of requesting the data
• Access Criteria: Data sharing will commence after Institutional Review Board (IRB) approval to share the data, from University of Wisconsin and the individual's institution

Locations

US (1)