60 Participants Needed

Amylopectin Chromium Blend for Menopause

TZ
ML
Overseen ByMicheal La Monica, Ph.D.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a nutritional supplement made from an amylopectin-chromium blend can help women in midlife improve protein balance and maintain muscle, particularly during menopause when hormonal changes can affect these areas. The trial compares the supplement to a placebo (a harmless fake treatment) and tests whether a higher dose is more effective. Women who have not had a period for at least 60 days and are experiencing menopause symptoms might be suitable candidates. Participants will take the supplement after exercise and attend several study visits. The goal is to find ways to support healthy aging and metabolism for women undergoing menopause. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance health and wellness during menopause.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop any dietary supplements that affect glucose control or insulin sensitivity and have a 2-week period without them before starting the study. A generic multivitamin is allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the amylopectin-chromium blend is generally well-tolerated. One study found that adding this blend to branched-chain amino acids (BCAAs) helped build muscle without major safety concerns. Another source confirmed that chromium, a component of the blend, remains safe even in high amounts, supporting the blend's safety profile. Additionally, the ingredient in the blend has received GRAS (Generally Recognized As Safe) status, indicating safety based on a thorough review. Overall, evidence suggests that the amylopectin-chromium blend is safe, with no significant negative effects reported in studies.12345

Why are researchers excited about this trial?

Unlike the standard treatments for menopause, which often include hormone replacement therapy and lifestyle changes, the amylopectin-chromium blend offers a unique approach by potentially targeting metabolic pathways. This treatment uses a new active ingredient, combining amylopectin with chromium, which is thought to influence insulin sensitivity and energy metabolism. Researchers are excited because this could provide an alternative for those who cannot or prefer not to use hormone-related therapies, offering a novel way to address symptoms associated with menopause.

What evidence suggests that this trial's treatments could be effective for menopause?

Research has shown that blends of amylopectin and chromium might help women going through menopause maintain better protein balance. This is important because menopause can affect how the body uses protein, which is essential for keeping muscles strong. Some studies suggest that these blends could help manage blood sugar levels, a common concern during menopause. Evidence indicates that chromium, a key part of the blend, can improve how the body processes sugar and support healthier aging. While more research is needed, these early findings are promising for women aiming to maintain muscle and overall health during midlife.15678

Who Is on the Research Team?

TZ

Tim Ziegenfuss, PhD

Principal Investigator

The Center for Applied Health Sciences

Are You a Good Fit for This Trial?

This trial is for peri/post-menopausal women aged 40-65, with a BMI of 18.5-34.9 and weighing at least 110 pounds. They should be in good health, not very active (max 3 days/week of exercise), and have had amenorrhea for at least 60 days but less than a year or be post-menopausal for over a year.

Inclusion Criteria

I have not had a period for 2 to 11 months.
* Be in good health and able to participate in an exercise bout as determined by assessment, medical history, and routine blood chemistries.
I am between 40 and 65 years old.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Assessment

Baseline assessments including clinical chemistry, complete blood count, lipid panel, vital signs, and body composition via bioimpedance analysis

1 week
1 visit (in-person)

Treatment

Participants consume the nutritional supplement or placebo after a resistance exercise bout, with continuous glucose monitoring and protein turnover assessment

2-3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Amylopectin-chromium blend

Trial Overview

Researchers are testing an amylopectin chromium blend to see if it helps maintain protein balance and glucose control after resistance exercise in midlife women. The study compares this supplement against a placebo, including standard and concentrated doses.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active 2Experimental Treatment1 Intervention
Group II: Active 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nutrition 21, Inc.

Lead Sponsor

Trials
7
Recruited
880+

The Center for Applied Health Sciences, LLC

Industry Sponsor

Trials
13
Recruited
620+

Citations

Effects of an Amylopectin Chromium Blend on Whole-Body ...

The goal of this study is to better understand how an amylopectin chromium blend may influence whole body protein balance in women during ...

Top Perimenopause Clinical Trials | Power

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 ...

Beneficial effects of hormonal replacement therapy on ...

Postmenopausal women exhibit an increased incidence of cardiovascular diseases, and type 2 diabetes mellitus compared with younger women.

Supplementation with Bioactive Compounds Improves Health ...

The results suggest that these bioactive compounds may be a beneficial strategy for promoting healthier aging in postmenopausal women by ...

Improvement in menopausal symptoms with a nutritional ...

Here we present the first clinical data in menopausal women wi- th this combination to demonstrate the efficacy and safety of this product. The results of this.

The addition of an amylopectin/chromium complex to ... - PMC

The results of this study provide evidence that the addition of ACr to BCAAs significantly enhances exercise-induced MPS, and the phosphorylation of mTOR ...

The safety and efficacy of high-dose chromium

The data on the standards for chromium requirements and the safety of various chromium compounds and doses are reviewed.

Nutrition 21's Velositol Ingredient Granted GRAS Status

The ingredient attained GRAS status following an “extensive and rigorous review of the scientific dossier and safety data,” which was conducted ...