Amylopectin‑chromium supplement and protein balance in peri- and post-menopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial will compare two doses of an amylopectin‑chromium blend versus an amylopectin placebo in approximately 60 healthy women aged 40–65. Participants will complete a short resistance exercise bout and then consume the assigned product co‑ingested with 20 g of protein from yogurt, with only a single acute dose given per participant. Stable isotope tracer methods will measure acute changes in whole‑body protein synthesis and breakdown, while continuous glucose monitoring will track 24‑hour glycemic responses. All visits take place at a single site in Canfield, Ohio, over a 2–3 week period with four in‑person visits per participant.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Center for Applied Health Sciences
  Canfield, Ohio, United States Recruiting

Study contacts

• Principal investigator: Tim Ziegenfuss, PhD — The Center for Applied Health Sciences, LLC
• Study coordinator: Tim Ziegenfuss, Ph.D.
• Email: tz@appliedhealthsciences.org
• Phone: 330-926-6927

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.