Recruiting

Amylopectin Chromium

Sponsor:

Nutrition 21, Inc.

Code:

NCT07402382

Conditions

Glucose Monitoring, Continuous

Whole Body Protein Metabolism

Peri-menopausal Women

Post-menopause

Eligibility Criteria

Sex: Female

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

Amylopectin-chromium blend

Concentrated Amylopectin-chromium blend

Placebo

Study Details

Brief 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.

Conditions

Glucose Monitoring, Continuous

Whole Body Protein Metabolism

Peri-menopausal Women

Post-menopause

Study ID

NCT07402382

Start date

Nov 1, 2025

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70

Healthy Volunteers: Accepted

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).
  • 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 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).
  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo

experimental: Active 1

Standard dose

experimental: Active 2

Concentrated dose

Interventions

Amylopectin-chromium blend

Amylopectin-chromium blend, 2 g

Concentrated Amylopectin-chromium blend

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

Placebo

Amylopectin, 2 g

Primary outcome measure

  • Whole-Body Protein Turnover (Protein Synthesis and Breakdown) [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Tim Ziegenfuss, Ph.D.

330-926-6927tz@appliedhealthsciences.org

Micheal La Monica, Ph.D.

330-926-6927ML@appliedhealthsciences.org

Locations

The Center for Applied Health Sciences

Recruiting

Canfield, Ohio, United States, 44406

More Information

Sponsor

Nutrition 21, Inc.

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Glucose
  • protein metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nutrition 21, Inc. on 2026-04-13.