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Single group for Quality of Life
N/A
Waitlist Available
Led By Floris Wardenaar, PhD
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 0), days 22, 23, 29, 36, 43.
Awards & highlights
Study Summary
This trial is testing whether a protein supplement can help people with GI complaints.
Eligible Conditions
- Quality of Life
- Digestive Health
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 0), days 22, 23, 29, 36, 43.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 0), days 22, 23, 29, 36, 43.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in daily self-reported digestive comfort
Change in self-reported digestive comfort
Secondary outcome measures
Chane in self-reported states of mood
Change in dietary intake
Change in participants microbiota composition of fecal samples
+2 moreOther outcome measures
Change in food composition and diet quality
Change in product experience
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single groupExperimental Treatment1 Intervention
During a 3-week baseline period, participants with self-reported GI complaints consume their own protein supplement that they use for recovery purposes after exercise, followed by a 3-week intervention period in which they maintain usage of their own product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. An additional reference group of athletes without self-reported GI complaints will also be followed during a 3-week period in which they consume their own protein supplement that they use for recovery purposes after exercise.
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Who is running the clinical trial?
FrieslandCampinaIndustry Sponsor
34 Previous Clinical Trials
4,999 Total Patients Enrolled
Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
109,416 Total Patients Enrolled
Floris Wardenaar, PhDPrincipal InvestigatorArizona State University
Frequently Asked Questions
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