Triple Protein for Healthy Women

Overseen By Abbie Smith-Ryan

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Whey protein, Pregnant, Lactose intolerant, others

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Abbie Smith-Ryan

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing to abstain from caffeine, tobacco, and alcohol for 24 hours before testing days

I am a woman between 30 and 60 years old.

BMI 18.5-40 kg/m^2

Exclusion Criteria

Lactose intolerant

Currently supplementing whey protein

Severe hearing or speech impairment or inability to speak English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing including DXA, fasting blood, and standardized meal test with 2-hour glucose and insulin sampling

1 week

1 visit (in-person)

Treatment

Participants consume daily Triple Support Protein or placebo for 4 weeks, with weekly check-ins and continuous glucose monitoring during the final 14 days

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including end-of-study DXA and blood tests

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Triple Protein Support

How Is the Trial Designed?

Group I: Triple Protein Support Experimental Treatment 1 Intervention

Daily one serving of plant-based protein + creatine + fiber mixed with 8-12 fl oz water for 4 weeks

Group II: Placebo Placebo Group 1 Intervention

Daily one serving of a non-caloric, texture- and weight-matched placebo for 4 weeks

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Perelel Inc.

Industry Sponsor

Trials

2

Recruited

100+