Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Men… (NCT07402382) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Menopausal Women
United States60 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
40 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Whole-Body Protein Turnover (Protein Synthesis and Breakdown)