Glycomacropeptide and Women’s Health

Overview

This is a study about how a dietary supplement containing a whey protein affects hunger 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 Title of Study: “Glycomacropeptide as a Protein Supplement to Curb Hunger”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 5, 2022

Detailed Description

The purpose of this research study is to understand how a dietary supplement containing glycomacropeptide (GMP) affects hunger and blood sugar levels. This study is being conducted to find new ways to help women lose weight and reduce their chance of getting diabetes.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: low dose GMP
    • We will conduct a pilot cross-over study in which 13 obese women 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 subjects 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.
  • Experimental: high dose GMP
    • After a washout period, the same 13 obese women 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.

Clinical Trial Outcome Measures

Primary Measures

  • Glucose
    • Time Frame: glucose levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial
    • Glucose homeostasis after a soy or GMP liquid breakfast

Secondary Measures

  • Satiety
    • Time Frame: Plasma satiety hormones 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial
    • Levels of insulin, glucagon, amylin, pancreatic polypeptide, leptin and ghrelin after a soy or GMP liquid breakfast

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karen E Hansen, MD, Principal Investigator, University of Wisconsin, Madison

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