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

NCT06946017 | Recruiting

• 1 other identifier: STUDY00020575
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Digestive Health; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Part I: Hydrogen in breath

  Hydrogen in breath as indicator of lactose malabsorption.

  For 240 minutes post exercise after consuming a bolus of lactose.

• Part II: Gastrointestinal Symptoms Rating Scores

  Gastrointestinal Symptoms Rating Scores (GSRS) as indicator of self-reported digestive comfort. The GSRS is a 15-item self-administered questionnaire divided into five clusters of symptoms: reflux, abdominal pain, indigestion, diarrhea, and constipation. These symptoms are graded on a 7-point Likert scale, where 1 signifies no discomfort at all and 7 represents very severe discomfort. The total score will be calculated, as well as the percentage of subjects reporting symptoms (≥2), or moderate to severe symptoms (≥4). A minimal score of indicates no GI symptoms, whereas a score up to 105 suggests extreme GI symptoms.

  For 240 minutes post exercise after consuming a bolus of lactose.

Secondary Outcomes (1)

• Part I and Part II: Fecal Bifidobacterium

  Stool sample collected at least one day before the test day including the exercise test

Other Outcomes (12)

• Part I: Gastrointestinal Symptoms Rating Scores

  Covering the last 7 days before each testing day.

• Part I and Part II: Self-reported general wellbeing

  At each testing day, before the exercise test.

• Part I and Part II: Self-reported general wellbeing

  At each testing day, before the exercise test.

Study Arms (2)

Fermented dairy protein with prebiotic fiber

EXPERIMENTAL

During 3-week period participants consume a fermented dairy protein with prebiotic fiber. During Part I participants are randomly assigned to start with the experimental arm or the control arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial). During Part II participants are randomly assigned to the experimental arm only (double blind, randomized parallel trial).

Dietary Supplement: Fermented dairy protein with prebiotic fiber supplement

Control protein supplement

PLACEBO COMPARATOR

During 3-week period participants consume a control supplement. During Part I participants are randomly assigned to start with the control arm or the experimental arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial). During Part II participants are randomly assigned to the control arm only (double blind, randomized parallel trial).

Dietary Supplement: Control placebo

Interventions

Fermented dairy protein with prebiotic fiber supplement DIETARY_SUPPLEMENT

Both the intervention and placebo products contain a serving of 15g with \~53Kcal, 0.5g Fats, 5g Carbohydrate, 7.5g Protein that need to be dissolved as powder in water in a protein shaker that will be provided. The intervention product contains whey protein concentrate and a prebiotic fiber. All ingredients that are designated by the FDA as Generally Recognized as Safe (GRAS). Participants will be asked to take the supplement daily before breakfast.

Fermented dairy protein with prebiotic fiber

Control placebo DIETARY_SUPPLEMENT

Both the intervention and placebo products contain a serving of 15g with \~53Kcal, 0.5g Fats, 5g Carbohydrate, 7.5g Protein that need to be dissolved as powder in water in a protein shaker that will be provided. The placebo product is calorically matched to the intervention product and the main ingredients are protein and carbohydrate. All ingredients that are designated by the FDA as Generally Recognized as Safe (GRAS). Participants will be asked to take the supplement daily before breakfast.

Control protein supplement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Healthy subjects living in the Phoenix area in AZ, USA during the study
• Women/Men aged between 18-50 years (50-50%)
• Recreational competitive and non-competitive athletes (exercise at least 2x per week with a minimal total duration of 2 hours/week)
• BMI value between ≥18.5 and ≤ 30 kg/m2
• No physical limitations due to an injury (i.e., able to perform all activities associated with daily living and exercise in an independent manner).
• Willing to slightly increase their energy intake via a supplement during the study period on daily basis in the morning before breakfast.
• Willing and comfortable to perform multiple physical (stress) tests on a treadmill during the study.
• Participants without any contraindications when scoring the Physical Activity Readiness Questionnaire (PAR-Q+).
• Written informed consent
• For part I: Self-perceived lactose intolerance, and/or omission of dairy products, and/or identifying as Hispanic/Latino or Asian
• 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)
• 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
• Women who plan to start or stop the use of contraceptives before or during study period
• Women that have additional or worse GI symptoms during their period that can be classified as severe
• Smoking

Sponsors & Collaborators

• Arizona State University: lead
• Friesland Campina: collaborator

Study Sites (1)

ASU Health Futures Center

Phoenix, Arizona, 85054, United States

RECRUITING

Related Publications (1)

• Wardenaar FC, Mohr AE, Ortega-Santos CP, Nyakayiru J, Kersch-Counet C, Chan Y, Clear AM, Kurka J, Schott KD, Seltzer RGN. Explorative Characterization of GI Complaints, General Physical and Mental Wellbeing, and Gut Microbiota in Trained Recreative and Competitive Athletes with or without Self-Reported Gastrointestinal Symptoms. Nutrients. 2024 May 30;16(11):1712. doi: 10.3390/nu16111712.

  PMID: 38892645 BACKGROUND

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Behavior

Central Study Contacts

Floris C Wardenaar, PhD

CONTACT

602-543-1853; Floris.wardenaar@asu.edu

Kinta Schott, MS

CONTACT

kschott3@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Nutrition

Model Details: Part I is a crossover design. Part II is a parallel design.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 27, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)