Glycomacropeptide and Women's Health

NCT05551091 — Not applicable, Completed, 13 participants, University of Wisconsin, Madison
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Glycomacropeptide as a Protein Supplement to Curb Hunger

RegistryNCT05551091, acronym GMP
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, crossover, masking: none, treatment
Enrollment13 (Actual)
SponsorUniversity of Wisconsin, Madison (Other)
ConditionsObesity
Interventionsglycomacropeptide (GMP) (Dietary supplement)
Datesstart 2019-04-09, primary completion 2022-07-05, completion 2022-07-05, first posted 2022-09-22, last updated 2022-10-03
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials of glycomacropeptide (GMP)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
GMP 25 mg BIDExperimentalDietary Supplement: 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 TIDExperimentalDietary Supplement: 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.
  • 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).

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: Female, ages: any to 90 Years, 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)

+Locations (1)

FacilityCityCountryStatus
University of Wisconsin-MadisonMadison, WisconsinUnited States

+Publications

  • Results publication: 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

+Investigators