Protein-Prebiotic Wellbeing Study

NCT05303753 | Completed

• 1 other identifier: STUDY00014399
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Health; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• Change in self-reported general wellbeing - Physical Health

  Baseline (day 0), after 21 days and after 42 days.

• Change in self-reported general wellbeing - Psychological Distress

  Baseline (day 0), after 21 days and after 42 days.

• Change in participants microbiota composition of fecal samples

  Baseline (day 0), after 21 days and after 42 days.

• Change in dietary intake

  Baseline (day 0), after 21 days and after 42 days.

• Chane in self-reported states of mood

  Baseline (day 0), after 21 days and after 42 days.

Other Outcomes (2)

• Change in food composition and diet quality

  Baseline (day 0), after 21 days and after 42 days.

• Change in product experience

  Baseline (day 0), days 22, 23, 29, 36, 43.

Study Arms (1)

Single group

OTHER

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

Interventions

fermented dairy protein with prebiotic fiber 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.

Single group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Participants can identify as: Male, Female, Non-binary/third gender, or as: Prefer not to say.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• FrieslandCampina: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

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

Study Officials

• Floris Wardenaar, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Modifying diet by adding a fermented dairy protein with prebiotic fiber

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 31, 2022
• Study Start: January 26, 2022
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)