RECRUITING

Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections. Part I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period). Part II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).

Official Title

Effect of a Fermented Whey and Fiber Supplement on Digestive Comfort of Recreational Athletes With and Without GI Complaints

Quick Facts

Study Start:2025-03-31
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06946017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy subjects living in the Phoenix area in AZ, USA during the study
  2. * Women/Men aged between 18-50 years (50-50%)
  3. * Recreational competitive and non-competitive athletes (exercise at least 2x per week with a minimal total duration of 2 hours/week)
  4. * BMI value between ≥18.5 and ≤ 30 kg/m2
  5. * No physical limitations due to an injury (i.e., able to perform all activities associated with daily living and exercise in an independent manner).
  6. * Willing to slightly increase their energy intake via a supplement during the study period on daily basis in the morning before breakfast.
  7. * Willing and comfortable to perform multiple physical (stress) tests on a treadmill during the study.
  8. * Participants without any contraindications when scoring the Physical Activity Readiness Questionnaire (PAR-Q+).
  9. * Written informed consent
  10. * For part I: Self-perceived lactose intolerance, and/or omission of dairy products, and/or identifying as Hispanic/Latino or Asian
  11. * For part I: Determined to be lactase non-persistent (LNP) CC genotype by qPCR, and/or positive lactose intolerance test (\>20ppm increase from baseline when 25g of lactose administered)
  1. * Users of (sport) supplements containing probiotics and/or prebiotics and those unwilling to temporarily stop use of these supplements at least 3 weeks prior to start of the intervention
  2. * Women who plan to start or stop the use of contraceptives before or during study period
  3. * Women that have additional or worse GI symptoms during their period that can be classified as severe
  4. * Smoking
  5. * Clinical lactose intolerance
  6. * Clinical or self-perceived milk protein allergy
  7. * Diagnosed GI tract disorders or diseases
  8. * Musculoskeletal disorders
  9. * Diagnosed metabolic disorders (such as diabetes)
  10. * Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
  11. * Chronic use of gastric acid suppressing medication or anti-coagulants
  12. * Chronic use of anti-inflammatory medication
  13. * Use of antibiotics the past 0-6 months
  14. * Blood donation in the past 2 months
  15. * (Intending to become) Pregnant/lactating women
  16. * Significant changes in body weight during the past 4 weeks (i.e., due to reduction of body weight through limiting caloric intake, illness,)
  17. * Athletes should not aim to lose bodyweight by reducing energy intake during the study
  18. * For Part I: A hydrogen breath peak of less than 20 ppm over baseline during a lactose tolerance test

Contacts and Locations

Study Contact

Floris C Wardenaar, PhD
CONTACT
602-543-1853
Floris.wardenaar@asu.edu
Kinta Schott, MS
CONTACT
kschott3@asu.edu

Study Locations (Sites)

ASU Health Futures Center
Phoenix, Arizona, 85054
United States

Collaborators and Investigators

Sponsor: Arizona State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Participants
  • Healthy subjects
  • Athlete
  • Women
  • Men
  • Fermented Dairy
  • Prebiotics
  • Gut microbiota
  • Self-reported
  • GI-tract
  • Diet
  • Immune markers
  • Exercise

Additional Relevant MeSH Terms

  • Digestive Health
  • Quality of Life