Purpose

This single-site, randomized, blinded, placebo-controlled study will evaluate whether 4 weeks of daily Triple Support Protein powder improves glycemic control and overall well-being in healthy women aged 30-60 years. Participants will undergo baseline testing (DXA, fasting blood, standardized meal test with 2-hour glucose and insulin sampling), complete one acute supervised dose, and then consume a daily supplement for 4 weeks. During the final 14 days, participants will wear a continuous glucose monitor. Outcomes include postprandial glucose AUC, insulin sensitivity, and body composition.

Condition

Eligibility

Eligible Ages
Between 30 Years and 60 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Females aged 30-60 years. - BMI 18.5-40 kg/m^2. - Recreationally active (≥30 min/wk moderate intensity exercise). - Healthy and free from disease per health history questionnaire. - Willing to abstain from caffeine, tobacco, and alcohol for 24 hours before testing days.

Exclusion Criteria

  • Currently supplementing whey protein. - Pregnant or nursing. - Lactose intolerant. - Currently using creatine monohydrate. - Severe hearing or speech impairment or inability to speak English

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, double-blind, placebo controlled parallel design
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Triple Protein Support
Daily one serving of plant-based protein + creatine + fiber mixed with 8-12 fl oz water for 4 weeks
  • Dietary Supplement: Triple protein support
    Plant based protein + creatine + fiber
Placebo Comparator
Placebo
Daily one serving of a non-caloric, texture- and weight-matched placebo for 4 weeks
  • Dietary Supplement: Placebo
    Non-caloric matched placebo

Recruiting Locations

Department of Exercise and Sport Science, Applied Physiology Laboratory
Chapel Hill, North Carolina 27713
Contact:
Applied Physiology Laboratory
919-962-1663
aplresearch@unc.edu

More Details

Status
Recruiting
Sponsor
University of North Carolina, Chapel Hill

Study Contact

Abbie Smith-Ryan
919-962-1663
aplresearch@unc.edu

Detailed Description

Midlife women experience hormonal changes that can impair metabolic health, sleep, and cognition. Triple plant-based protein powder includes creatine and fiber aimed at glycemic control, muscle support, and satiety. Design: 40 participants randomized (1:1) to Triple Protein Support vs. matched placebo for 4 weeks, with acute and chronic phases, weekly check-ins. Assessments: Baseline and end-of-study DXA and bloods; standardized meal tests with 2-hour glucose/insulin sampling; Analysis: Mixed-model ANOVA for primary and secondary endpoints with α=0.05.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.