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

NCT07402382 | Recruiting

• 1 other identifier: EH-01-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Keywords

Glucose; protein metabolism

Outcome Measures

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.

  24 hours

Secondary Outcomes (1)

• Interstitial Glucose Concentration measured using 24-24-hour continuous glucose monitoring

  Day 0 to day 6

Other Outcomes (2)

• Blood pressure (systolic and diastolic)

  Day 0, 5, and 6

• Heart rate

  Day 0, 5, and 6

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Active 1

EXPERIMENTAL

Standard dose

Dietary Supplement: Amylopectin-chromium blend

Active 2

EXPERIMENTAL

Concentrated dose

Dietary Supplement: Concentrated Amylopectin-chromium blend

Interventions

Concentrated Amylopectin-chromium blend DIETARY_SUPPLEMENT

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

Active 2

Amylopectin-chromium blend DIETARY_SUPPLEMENT

Amylopectin-chromium blend, 2 g

Active 1

Placebo DIETARY_SUPPLEMENT

Amylopectin, 2 g

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: collaborator
• Nutrition 21, Inc.: lead

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

RECRUITING

Study Officials

• Tim Ziegenfuss, PhD

  The Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Ziegenfuss, Ph.D.

CONTACT

330-926-6927; tz@appliedhealthsciences.org

Micheal La Monica, Ph.D.

CONTACT

330-926-6927; ML@appliedhealthsciences.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: February 11, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)