Protein-Prebiotic Wellbeing Study

Sponsor

Arizona State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05303753

Collaborator

FrieslandCampina (Industry)

100

Enrollment

Location

Arm

10.2

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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-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.

Condition or Disease	Intervention/Treatment	Phase
Digestive Health Quality of Life	Other: fermented dairy protein with prebiotic fiber	N/A

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. Emerging studies are showing a positive correlation between the gut microbiome and muscle function, athletic performance, body composition, and natural energy levels. This study will perform an exploratory analysis of the well-being and digestive health of well-trained athletes, and assess the potential effect of fermented dairy protein with prebiotic fiber on these parameters.

Question 1: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber affect the self-reported digestive comfort compared to a 3-week baseline period? And additionally, will the quality of life (self-reported general well-being and states of mood) change with the use of this type of product?

Question 2: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber show an alteration in gut microbiota in comparison to a 3-week baseline period, while dietary intake remains unaffected?

Question 3: How is the 3-week supplementation of a fermented dairy protein with prebiotic fiber experienced by the participants (taste and concept liking)?

Question 4: Is there a difference in baseline gut microbiota between athletes with and athletes without self-reported GI complaints.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Modifying diet by adding a fermented dairy protein with prebiotic fiberModifying diet by adding a fermented dairy protein with prebiotic fiber

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

An Exploratory Study on the Effect of Fermented Dairy Protein With Prebiotic Fiber in Athletes

Actual Study Start Date :

Jan 26, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Single group During a 3-week baseline period, participants with self-reported GI complaints consume their own protein supplement that they use for recovery purposes after exercise, followed by a 3-week intervention period in which they maintain usage of their own product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. An additional reference group of athletes without self-reported GI complaints will also be followed during a 3-week period in which they consume their own protein supplement that they use for recovery purposes after exercise.	Other: fermented dairy protein with prebiotic fiber During the intervention period, the participant will consume a new product and will reduce the amount of protein in their normal diet reflecting the protein content of the new product.

Arm

Intervention/Treatment

Other: Single group

During a 3-week baseline period, participants with self-reported GI complaints consume their own protein supplement that they use for recovery purposes after exercise, followed by a 3-week intervention period in which they maintain usage of their own product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. An additional reference group of athletes without self-reported GI complaints will also be followed during a 3-week period in which they consume their own protein supplement that they use for recovery purposes after exercise.

Other: fermented dairy protein with prebiotic fiber

During the intervention period, the participant will consume a new product and will reduce the amount of protein in their normal diet reflecting the protein content of the new product.

Outcome Measures

Primary Outcome Measures

Change in self-reported digestive comfort [Baseline (day 0), after 21 days and after 42 days.]
Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)
Change in daily self-reported digestive comfort [Study period covering day 1 to day 21 compared to day 22-42.]
Daily variation of GI complaints (averaged itemized score 1-10)

Secondary Outcome Measures

Change in self-reported general wellbeing - Physical Health [Baseline (day 0), after 21 days and after 42 days.]
Reported as physical wellbeing (Physical Health Questionnaire, PHX - average score 1-7 based on 14 items)
Change in self-reported general wellbeing - Psychological Distress [Baseline (day 0), after 21 days and after 42 days.]
Reported as psychological distress (mental distress, K6 scale - average score 0-24).
Change in participants microbiota composition of fecal samples [Baseline (day 0), after 21 days and after 42 days.]
16s microbial profiling
Change in dietary intake [Baseline (day 0), after 21 days and after 42 days.]
24-hour dietary recalls (food group intake, energy and macro- and micronutrient)
Chane in self-reported states of mood [Baseline (day 0), after 21 days and after 42 days.]
Profile of Mood States (POMS)

Other Outcome Measures

Change in food composition and diet quality [Baseline (day 0), after 21 days and after 42 days.]
Rapid eating assessment in participants (REAP)
Change in product experience [Baseline (day 0), days 22, 23, 29, 36, 43.]
Question about product experience (taste and concept liking)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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