RecruitingNot ApplicableNCT07402382

Effects of an Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose Control in Peri/Post-Menopausal Women

Sponsor

Nutrition 21, Inc.

Enrollment

60 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Post-menopause Glucose Monitoring, Continuous Whole Body Protein Metabolism Peri-menopausal Women

Summary

The goal of this study is to better understand how an amylopectin chromium blend may influence whole body protein balance in women during midlife, when hormonal changes can adversely affect protein metabolism and muscle maintenance. Continuous glucose monitoring will also be used to assess glycemic control over a 24-hour period. The main questions the study aims to answer are: * Does the use of an amylopectin chromium blend in peri- and post-menopausal women help to support positive protein balance * Can the affect be achieved using a concentrated dose Researchers will compare the nutritional supplement to a placebo (amylopectin alone) to see if the amylopectin chromium blend can promote positive protein balance. A concentrated dose of the supplement will also be evaluated for comparative effectiveness. Participants will: * Consume the nutritional supplement (standard or concentrated dose) or placebo acutely after a short resistance exercise bout * Complete four in-person visits, including the single-day intervention Results from this research may help guide future nutritional strategies to support healthy aging, muscle function, and overall metabolic health.

Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 65 Years

Inclusion Criteria16

Women aged 40-65 years who meet either of the following menstrual-history criteria:
≥ 60 days but \< 12 months of amenorrhea (late perimenopause)
Women with ≥ 12 months of spontaneous amenorrhea (post-menopausal)
No more than 3 days per week of structured physical activity
Provide voluntary signed and dated informed consent.
Be in good health and able to participate in an exercise bout as determined by assessment, medical history, and routine blood chemistries.
Between the of 40 and 65 years of age (inclusive).
Body Mass Index of 18.5-34.9 (inclusive).
Body weight of at least 110 pounds.
Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
Normal supine, resting heart rate (\<90 per minute).
Subject agrees to follow standardized controlled diet for 3 days and maintain existing dietary patterns on other days throughout the study period.
Subject is willing and able to comply with the study protocol.
Able to provide an adequate blood draw.
If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study. Note: A generic multivitamin is allowed.
Refrain from caffeine, exercise, and alcohol for 24 hours prior, and fast for 10 hours prior to each visit.

Exclusion Criteria14

Current use of any dietary ingredient that impacts glucose control or insulin sensitivity.
Current vegans or vegetarians.
Intolerance to dairy foods/drinks.
Smokes more than 10 cigarettes per day or uses other nicotine products (i.e. vape, patch) that deliver a similar amount of nicotine.
History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
Prior gastrointestinal bypass surgery (Lapband, etc.).
Individuals using any kind of GLP-1 medications.
Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
Individuals who have gained or lost more than 10 pounds within the last 30 days.
Individuals who are cognitively impaired and/or who are unable to give informed consent.
Chronic medically diagnosed inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.