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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-70
SponsorNutrition 21, Inc.

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 volunteers

Qualifiers

≥ 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

Design model

Parallel

Treatments tested in this trial

  • Amylopectin-chromium blend

    Dietary supplement

    Amylopectin-chromium blend, 2 g

  • Concentrated Amylopectin-chromium blend

    Dietary supplement

    Amylopectin-chromium blend in a concentrated format (100 mg)

  • Placebo

    Dietary supplement

    Amylopectin, 2 g

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Active 1Experimental treatment 1 intervention
Group C: Active 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

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

Time frame
Day 0 to day 6

Other outcomes

1

Blood pressure (systolic and diastolic)

Systolic and diastolic blood pressure will be measured using a standard automated blood pressure device under resting conditions.

Time frame
Day 0, 5, and 6
2

Heart rate

Heart rate will be measured using a standard automated blood pressure device under resting conditions.

Time frame
Day 0, 5, and 6

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