Amylopectin Chromium Blend for Protein and Glucose in Peri/Post-Menopausal Women

This study is looking at how a dietary supplement called amylopectin-chromium blend affects protein balance and blood sugar (glucose) levels in women who are going through or have completed menopause. During this time, hormonal changes can impact how your body uses protein and maintains muscle. Researchers want to see if taking the amylopectin-chromium blend, either as a regular dose (2 grams) or a concentrated dose (100 milligrams), can help your body maintain a healthy protein balance. They will compare these supplements to a placebo, which is just amylopectin without the chromium. You may be able to join if you are a woman between 40 and 70 years old, are in late perimenopause or post-menopause, and don't do more than three days a week of structured exercise. The study's main goal is to see if this blend helps support positive protein balance. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are assigned by chance to one of three groups, and neither you nor the researchers will know which treatment you are receiving. About 60 women will participate.
What's involved
You would complete four in-person visits over a 2-3 week period: one screening visit and three testing visits. These visits will include blood tests, body composition measurements, and continuous glucose monitoring.
Compensation
Not stated in the trial record.
Follow-up
Your whole-body protein turnover will be measured at 24 hours after taking the supplement.

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NCT07402382

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

Recruiting
NAAges 40–70InterventionalBasic science
Nutrition 21, Inc.
~60 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Amylopectin-chromium blendConcentrated Amylopectin-chromium blendPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Whole-Body Protein Turnover (Protein Synthesis and Breakdown)
Measured over 24 hours
Glucose Monitoring, Continuous
Whole Body Protein Metabolism
Peri-menopausal Women
Post-menopause
1 sites across 1 states
Ohio1
  • Tim Ziegenfuss, PhD · PRINCIPAL_INVESTIGATOR · The Center for Applied Health Sciences, LLC

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Eligibility criteria

Inclusion

≥ 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

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.
  • 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 in response to the intervention.