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

What this trial studies

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.

Conditions in scope

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

Interventions

• 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

Who can join

Women only · Ages 40 Years to 70 Years · Accepts healthy volunteers.

Inclusion criteria

• 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).

Exclusion criteria

• 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).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-11-01
• Primary completion: 2026-06-30
• Last update posted: 2026-04-13
• First posted: 2026-02-11

Sponsor & contact

Lead sponsor: Nutrition 21, Inc. (Industry)

Collaborators: The Center for Applied Health Sciences, LLC

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Whole-Body Protein Turnover (Protein Synthesis and Breakdown) (24 hours)
  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…

Related ClearedRx care

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