NCT07402382

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nutrition 21, Inc. · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

This randomized, double-blind, placebo-controlled clinical trial will evaluate the effects of two dosage forms of an amylopectin-chromium blend on whole-body protein balance in peri- and post-menopausal women. The study will employ a stable isotope tracer methodology to quantify acute changes in protein synthesis and breakdown following a standardized resistance exercise bout and protein ingestion. Continuous glucose monitoring will assess the impact of the supplement on glycemic control over a 24-hour period. Approximately 60 apparently healthy women, aged 40-65 years, will be enrolled at a single clinical site (The Center for Applied Health Sciences, Canfield, OH). Participants will complete four in-person visits over a 2-3-week period: one screening visit and three testing visits. Following screening and baseline assessments (including clinical chemistry, complete blood count, lipid panel, vital signs, and body composition via bioimpedance analysis), eligible participants will be randomly assigned to one of three groups: 1. Amylopectin-chromium blend, 2 g co-ingested with 20 g of protein from yogurt, 2. Concentrated Amylopectin-chromium blend, 100 mg, co-ingested with 20 g of protein from yogurt, or 3. Placebo (2 g amylopectin) co-ingested with 20 g of protein from yogurt. Each participant will receive only one product dose during the study. Group assignment will be randomized and blinded to both participants and investigators. Prior to dosing, participants will undergo exercise familiarization and 5-repetition-maximum testing for leg press and leg extensions. At Visit 3 (Day 5), participants will ingest a single oral dose of ¹⁵N-alanine (2 g) as a metabolic tracer, and then will perform a standardized resistance exercise protocol (3 × 12-15 repetitions each of leg press and leg extension at 60-65 % of estimated 1RM, with 2-minute rest intervals). Immediately following exercise, the assigned study product with yogurt protein will be ingested. A second 20 g yogurt protein serving will be consumed with the evening meal to maintain uniform post-exercise protein intake. Urinary nitrogen enrichment (¹⁵N-urea) will be measured from 24-hour urine collections (0-12 h and 12-24 h) to determine protein turnover rates. Blood samples obtained at multiple time points will assess biochemical responses, including blood urea nitrogen and isotope enrichment. Whole-body protein synthesis and breakdown will be calculated from tracer kinetics. Continuous glucose monitoring will capture interstitial glucose fluctuations. Throughout the study, participants will follow a controlled diet standardized for energy and macronutrient content (approximately 1.1 g protein/kg body weight/day) and will abstain from alcohol, caffeine, and strenuous exercise for 24 hours before each visit. Compliance with dietary controls will be verified using the ASA24 or USDA Food Data Central tools. Adverse events, vital signs, and anthropometrics will be monitored at each visit. The total blood volume collected will be approximately 38 mL. No major safety risks are anticipated; potential discomforts include mild gastrointestinal upset, muscle soreness from resistance exercise, and transient local effects from blood draws. The primary study outcomes are changes in whole-body protein synthesis and breakdown measured by ¹⁵N-alanine tracer methodology. Secondary outcomes include indices of glucose control, derived from continuous glucose monitoring, and safety/tolerability endpoints. This study will provide mechanistic insight into the acute effects of the amylopectin-chromium blend on whole-body protein balance in peri- and post-menopausal women, contributing to the broader understanding of nutritional interventions that support muscle health and metabolic function during midlife.

Conditions

• Glucose Monitoring, Continuous
• Whole Body Protein Metabolism
• Peri-menopausal Women
• Post-menopause

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2026-02-11
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States