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Evaluating change in the colonic luminal environment with protein supplementation (EAT PROTEIN)

Evaluating change in the colonic luminal environment with protein supplementation in healthy adults (EAT PROTEIN)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001270505
Acronym
EAT-PROTEIN
Enrollment
4
Registered
2024-10-18
Start date
2025-04-10
Completion date
2025-05-22
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine the effect of protein-supplementation on faecal hydrogen sulphide production in healthy adult males. We hypothesise that protein supplementation will altern the colonic microbial environment but be safe, tolerable and adhered to by healthy adult males.

Interventions

The intervention in this trial is protein supplementation. The intervention will be provided in the form of "ingredient sachets" which will be developed in a research/commercial level kitchen. The protein-based ingredient sachets will contain 30g of whey protein isolate and 20g of full cream milk powder. Participants will consume three ingredient sachets per day, during the intervention weeks, incorporating them into their habitual diet by making into drinks or adding to food items. All particip

The intervention in this trial is protein supplementation. The intervention will be provided in the form of "ingredient sachets" which will be developed in a research/commercial level kitchen. The protein-based ingredient sachets will contain 30g of whey protein isolate and 20g of full cream milk powder. Participants will consume three ingredient sachets per day, during the intervention weeks, incorporating them into their habitual diet by making into drinks or adding to food items. All participants will have two weeks of protein supplementation, followed by four weeks of habitual diet, followed by two weeks of protein supplementation (counterbalanced design). Participants will receive education from a research dietitian at a face-to-face 1-hour appointment at the hospital clinic. The education will be tailored to their individual diet to assist with adherence and to ensure maintenance of isocaloric intake to their habitual diet. Participants will also receive a supplementation guide developed for the purpose of this study, providing ideas of how to prepare the ingredient sachets. Adherence will be assessed via self-reported questionnaire indicating number of non-adherent days and confirmed by participants returning their supplement packaging.

Sponsors

The Queen Elizabeth Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Healthy adult males aged 18 years or older who are able to provide informed consent and willing to consume animal-based protein supplemented ingredient sachets

Exclusion criteria

Female sex, aged less than 18 years of age. Any previous gastrointestinal surgery and diagnosis of any gastrointestinal disorders. Diagnosis of any chronic renal or liver failure. Significant psychiatric or cognitive co-morbidities or unable to provide informed consent. Diagnosis of cows milk protein allergy, soy allergy or lactose intolerance. Individuals currently enrolled in another clinical trial. Washout periods required for: - no protein supplementation in the past 2 weeks before trial commencement. - no medications that alter bowel habit in the past 2 weeks before trial commencement (laxatives, probiotics, opioids, anti-emetics) - no antibiotics or corticosteroids for any infection or other medical reason in the past 4 weeks - no COVID-19 infection in the past 4 weeks

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026