Health TrialsbyHealthPanel

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

ConditionsDigestive HealthQuality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorArizona State University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Fermented dairy protein with prebiotic fiberExperimental treatment 1 intervention
Group B: Control protein supplementPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part I: Hydrogen in breath

Hydrogen in breath as indicator of lactose malabsorption.

Time frame
For 240 minutes post exercise after consuming a bolus of lactose.
2

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.

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

Secondary outcomes

1

Part I and Part II: Fecal Bifidobacterium

Fecal Bifidobacterium as a (partial) mechanistic explanation for a change in carbohydrate (lactose) absorption or self-reported digestive comfort.

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

Other outcomes

1

Part I: 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.

Time frame
Covering the last 7 days before each testing day.
2

Part I and Part II: Self-reported general wellbeing

Self-reported general wellbeing using the Physical Health Questionnaire (PHQ). The PHQ covers sleep disturbance, headache, GI problems, and respiratory infections using 14 items with Likert scales scoring in the range of 1-7, from "not at all" to "all the time". The total score is in the range of 14-98, where a low score indicates better physical health.

Time frame
At each testing day, before the exercise test.
3

Part I and Part II: Self-reported general wellbeing

Self-reported general wellbeing using the psychological Distress Scale (K6). The K6 addresses depressed mood, motor agitation, fatigue, worthless guilt, and anxiety. The K6 uses a 0-3 Likert scale, ranging from "none of the time" to "all of the time". Total score is in the range of 0-18, where a low score indicates low mental distress, with ≥13 suggesting mental distress.

Time frame
At each testing day, before the exercise test.
4

Part I and Part II: Self-reported general wellbeing

Self-reported general wellbeing using the subjective vitality scale (SVS). The SVS holds 7 items covering feelings related to energy and feeling alive with Likert scales scoring in the range of 1-7, from "not at all true" to "very true". The total score is in the range of 7-49, where a low score indicates not being feeling vital and energized, whereas higher scores suggest the opposite.

Time frame
At each testing day, before the exercise test.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arizona State University

Lead sponsor

Friesland Campina

Collaborator

Source ClinicalTrials.gov
Apply now