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NCT07402382 · Nutrition 21, Inc.

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

What this study is about

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.

View original scientific description

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.

Interventions

DIETARY_SUPPLEMENT

Amylopectin-chromium blend

Amylopectin-chromium blend, 2 g

DIETARY_SUPPLEMENT

Concentrated Amylopectin-chromium blend

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

DIETARY_SUPPLEMENT

Placebo

Amylopectin, 2 g

Primary outcome measures

Whole-Body Protein Turnover (Protein Synthesis and Breakdown)

Time frame: 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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

  • Canfield, Ohio

Collaborators

The Center for Applied Health Sciences, LLC

Related conditions & keywords

Glucose Monitoring, ContinuousWhole Body Protein MetabolismPeri-menopausal WomenPost-menopauseGlucoseprotein metabolism

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations

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1 of 60 participants interested
2% interest

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Study locations

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RECRUITING

Canfield

Ohio

Location available

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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If you're searching for Glucose Monitoring, Continuous treatment in Canfield, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Canfield and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Glucose Monitoring, Continuous. All study-related care is provided at no cost to participants.

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1 locations in Ohio
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Why Consider a Clinical Trial for Glucose Monitoring, Continuous?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Glucose Monitoring, Continuous

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Glucose Monitoring, Continuous Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07402382. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.