Actively Recruiting
Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Menopausal Women
Led by Nutrition 21, Inc. · Updated on 2026-04-13
60
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
N
Nutrition 21, Inc.
Lead Sponsor
T
The Center for Applied Health Sciences, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Menopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 40 to 65 years
- Late perimenopause defined as 60 days but less than 12 months of amenorrhea, or post-menopause with 12 or more months of spontaneous amenorrhea
- Engage in no more than 3 days per week of structured physical activity
- Able and willing to provide signed informed consent
- In good health and able to participate in resistance exercise as determined by medical history and blood tests
- Body Mass Index between 18.5 and 34.9 inclusive
- Body weight at least 110 pounds
- Normotensive with seated resting blood pressure less than 140/90 mm Hg
- Resting heart rate less than 90 beats per minute
- Agree to follow a standardized controlled diet for 3 days and maintain usual diet on other days during the study
- Willing and able to comply with the study protocol
- Able to provide adequate blood samples
- If using dietary supplements, willing to discontinue for 2 weeks prior to participation (multivitamins allowed)
- Willing to abstain from caffeine, alcohol, and exercise for 24 hours before each visit and fast for 10 hours prior to visits
You will not qualify if you...
- Current use of dietary ingredients impacting glucose control or insulin sensitivity
- Current vegan or vegetarian diet
- Intolerance to dairy foods or drinks
- Smoking more than 10 cigarettes per day or use of nicotine products delivering similar nicotine amounts
- History of malignancy in past 5 years except non-melanoma skin cancer
- Prior gastrointestinal bypass surgery
- Use of any GLP-1 medications
- Known gastrointestinal or metabolic diseases affecting nutrient absorption or metabolism
- Weight change of more than 10 pounds in the last 30 days
- Cognitive impairment or inability to give informed consent
- Chronic inflammatory diseases such as rheumatoid arthritis, Crohn's disease, lupus, HIV/AIDS
- History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease
- Sensitivity to ingredients in the test formulations
- Any condition deemed by medical staff to confound study results or increase risk of harm
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Center for Applied Health Sciences
Canfield, Ohio, United States, 44406
Actively Recruiting
Research Team
T
Tim Ziegenfuss, Ph.D.
CONTACT
M
Micheal La Monica, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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