Protein-Prebiotic Wellbeing Study

NCT ID: NCT05303753

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2022-07-11

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.

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.

Conditions

Digestive Health; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

fermented dairy protein with prebiotic fiber

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FrieslandCampina

INDUSTRY

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Floris Wardenaar, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

STUDY00014399

Identifier Type: -

Identifier Source: org_study_id