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New treatment option for Glucose Monitoring, Continuous
Official title Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Menopausal Women
ClinicalTrials.gov ID: NCT07402382
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70, women only. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join 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.).
See the full eligibility 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)...
- 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...
- Refrain from caffeine, exercise, and alcohol for 24 hours prior, and fast for 10 hours prior to each visit.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canfield, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canfield, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.