Status:
COMPLETED
Protein-Prebiotic Wellbeing Study
Lead Sponsor:
Arizona State University
Collaborating Sponsors:
FrieslandCampina
Conditions:
Digestive Health
Quality of Life
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
Healthy participants with self-reported GI complaints will consume the protein supplement that they normally use for recovery purposes after exercise during a 3-week baseline period, followed by a 3-w...
Detailed Description
A substantial number of athletes suffer from gastro-intestinal problems, which may impair performance and/or subsequent recovery. Also, gut barrier integrity is impaired with high-intensity training. ...
Eligibility Criteria
Inclusion
- Healthy subjects living in Arizona in the USA
- Women/Men aged between 18-35 years
- Serious athletes (exercise at least 3 x per week)
- With or without GI tract issues due to sport or protein/diet intake
- 5 ≤ BMI ≤ 40 kg/m2
- No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
- Use of a protein supplement or sports food after at least one training per day 3 x per week
- Willing to slightly increase their protein supplement intake during the intervention phase for 21 consecutive days
- Stable weight during the last 4 weeks, without a focus on body weight reduction through limiting caloric intake
- Written informed consent
Exclusion
- Daily use of (sport) supplements containing probiotics and/or prebiotics
- Smoking
- Self-reported cow's milk protein allergy
- Clinical lactose intolerance
- Clinical milk protein allergy
- House dust mite allergy
- Diagnosed GI tract disorders or diseases
- Musculoskeletal disorders
- Metabolic disorders (such as diabetes)
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
- Chronic use of gastric acid-suppressing medication or anti-coagulants
- Use of antibiotics or anti-inflammatory medication the past 2 weeks
- Blood donation in the past 2 months
- Pregnant/lactating women
- Athletes should not aim to lose body weight by reducing energy intake during the study
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05303753
Start Date
January 26 2022
End Date
July 11 2022
Last Update
April 3 2025
Active Locations (1)
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1
Arizona State University
Phoenix, Arizona, United States, 85004