Protein-Prebiotic Wellbeing Study

Completed · Not applicable

Conditions studied: Digestive Health, Quality of Life

In brief

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-week intervention period in which they maintain usage of their product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. In addition, a group of healthy participants without self-reported GI complaints will serve as a reference group by consuming the protein supplement that they normally use for recovery purposes after exercise during a 3-week period.

Key facts

Study ID

NCT05303753

Run by

Arizona State University

People needed

98

Starts

2022-01-26

Expected to finish

2022-07-11

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 18.5 ≤ 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

You may not qualify if…

• 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

Where it is running

• Arizona State University — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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