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The effect of a dairy based protein complex (IDP®) on stress-induced intestinal barrier dysfunction

The effect of a dairy based protein complex (IDP®) on stress-induced intestinal barrier dysfunction in healthy adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001560886
Enrollment
18
Registered
2021-11-17
Start date
2022-02-21
Completion date
2022-10-03
Last updated
2024-06-24

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

Conditions

None listed

Brief summary

Disruption of the intestinal barrier and increased intestinal permeability may play a role in chronic intestinal conditions (such as celiac disease, inflammatory bowel disease, and irritable bowel syndrome), as well as pathological or inflammatory states such as obesity, diabetes and rheumatoid arthritis. In healthy individuals, barrier dysfunction can be caused by a number of stressors including endurance exercise, non-steroidal anti-inflammatory drugs, or dietary factors such as emulsifiers in foods. Increased permeability can lead to an inflammatory cascade that exacerbates the loss of barrier function and, if left unmanaged, can lead to poor digestive or systemic health conditions. However, certain dietary factors may improve barrier permeability by supporting digestive and immune health. This project will investigate whether 14 days of consuming a patented complex of bioactive milk-derived proteins (Immune Defense Proteins (IDP)® ) can mitigate exercise-induced intestinal barrier dysfunction in 18 healthy adults, aged between 18 and 45 years. After 14 days of supplementation with either IDP or a placebo, participants will undertake 20 minutes of high-intensity running before ingesting a sugar solution. Urine will then be collected over 5 hours and analysed for markers of gut permeability. After a 14 day washout, participants will complete the same protocol using the opposite treatment (IDP or placebo). We hypothesise that 14 days of consuming IDP will reduce the increase in intestinal permeability caused by exercise stress in healthy adults.

Interventions

At the start of each 14 day treatment period, participants will be provided with 14 stick sachets containing 2 g net weight of dry powder. One stick sachet will be consumed daily, mixed with cold or tepid water. For the IDP® intervention, the sachets will contain (in order of decreasing concentration): skim milk powder, whole milk powder, IDP® (200 mg), dextrose, and monk fruit extract. IDP® is a patented complex of bioactive milk-proteins, manufactured and commercialised by Quantec Ltd for us

At the start of each 14 day treatment period, participants will be provided with 14 stick sachets containing 2 g net weight of dry powder. One stick sachet will be consumed daily, mixed with cold or tepid water. For the IDP® intervention, the sachets will contain (in order of decreasing concentration): skim milk powder, whole milk powder, IDP® (200 mg), dextrose, and monk fruit extract. IDP® is a patented complex of bioactive milk-proteins, manufactured and commercialised by Quantec Ltd for use in human health applications. A washout of at least 14 days will occur, before participants complete the second 14 day treatment period. To ensure adherence to the intervention, participants will be asked to return the stick sachets when they return to the laboratory on day 7 and 14 of each treatment period. Additionally, the researchers will send participants a daily text to check that they have consumed the sachets.

Sponsors

Massey University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy, active males and females

Exclusion criteria

- Any illness in the four weeks prior to the trial beginning - Smokers (casual or habitual) - Any use of non-steroidal anti-inflammatory medication in the four weeks prior to the trial beginning - Pregnant - Any lower body musculoskeletal injury or other health conditions/contraindications to exercise - Gastrointestinal disorder or recent surgery - Known or suspected allergy to dairy products, starch, gluten, or artificial sweeteners

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026