Glycomacropeptide and Women's Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-09

Study Completion Date

2022-07-05

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GMP 25 mg BID

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.

Group Type EXPERIMENTAL

glycomacropeptide (GMP)

Intervention Type 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 TID

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.

Group Type EXPERIMENTAL

glycomacropeptide (GMP)

Intervention Type 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).

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes