Protein-Prebiotic Wellbeing Study

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05303753
• Other study ID #: STUDY00014399
• Status: Completed
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: July 11, 2022

Study information

• Verified date: September 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive Health
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	FrieslandCampina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in food composition and diet quality	Rapid eating assessment in participants (REAP)	Baseline (day 0), after 21 days and after 42 days.
Other	Change in product experience	Question about product experience (taste and concept liking)	Baseline (day 0), days 22, 23, 29, 36, 43.
Primary	Change in self-reported digestive comfort	Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)	Baseline (day 0), after 21 days and after 42 days.
Primary	Change in daily self-reported digestive comfort	Daily variation of GI complaints (averaged itemized score 1-10)	Study period covering day 1 to day 21 compared to day 22-42.
Secondary	Change in self-reported general wellbeing - Physical Health	Reported as physical wellbeing (Physical Health Questionnaire, PHX - average score 1-7 based on 14 items)	Baseline (day 0), after 21 days and after 42 days.
Secondary	Change in self-reported general wellbeing - Psychological Distress	Reported as psychological distress (mental distress, K6 scale - average score 0-24).	Baseline (day 0), after 21 days and after 42 days.
Secondary	Change in participants microbiota composition of fecal samples	16s microbial profiling	Baseline (day 0), after 21 days and after 42 days.
Secondary	Change in dietary intake	24-hour dietary recalls (food group intake, energy and macro- and micronutrient)	Baseline (day 0), after 21 days and after 42 days.
Secondary	Chane in self-reported states of mood	Profile of Mood States (POMS)	Baseline (day 0), after 21 days and after 42 days.