About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
≥ 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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Amylopectin-chromium blend
Dietary supplementAmylopectin-chromium blend, 2 g
Concentrated Amylopectin-chromium blend
Dietary supplementAmylopectin-chromium blend in a concentrated format (100 mg)
Placebo
Dietary supplementAmylopectin, 2 g
Treatment groups
Trial outcomes
Primary outcomes
Whole-Body Protein Turnover (Protein Synthesis and Breakdown)
This study will evaluate the effect of a dietary supplement consumed with protein and resistance exercise on whole-body protein turnover in healthy adults. Whole-body protein synthesis and breakdown will be assessed using a stable isotope tracer methodology following ingestion of a non-radioactive, isotope-labeled amino acid. Urine and blood samples will be collected over a 24-hour period to quantify protein turnover in response to the intervention.
Secondary outcomes
Interstitial Glucose Concentration measured using 24-24-hour continuous glucose monitoring
Interstitial glucose concentrations will be measured continuously using a blinded continuous glucose monitoring system worn on the upper arm. Glucose data will be collected over a 6-day monitoring period and used to derive summary measures including mean glucose concentration and indices of glycemic variability, pre- and post-intervetion
Other outcomes
Blood pressure (systolic and diastolic)
Systolic and diastolic blood pressure will be measured using a standard automated blood pressure device under resting conditions.
Heart rate
Heart rate will be measured using a standard automated blood pressure device under resting conditions.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nutrition 21, Inc.
Lead sponsor
The Center for Applied Health Sciences, LLC
Collaborator