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PuDDing trial: Protein-augmented Dairy Dessert nutrient delivery and digestion in females

The impact of firm compared to soft coagulated protein-augmented bovine dairy gel on the appearance of amino acids in peripheral blood in healthy female adults.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001418763
Acronym
PuDDing Trial
Enrollment
20
Registered
2022-11-07
Start date
2023-01-13
Completion date
2023-05-05
Last updated
2023-10-23

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 structure of ruminant milks is an important factor influencing their health and nutritional properties. Although food processing techniques change the structure of milks, not much is known about how these changes affect digestion, and the resulting health effects. This study aims to compare the digestive responses to two structurally different processed dairies with the same composition, to better understand the influence of processing on digestion and nutrient delivery. To do this, acute responses to two dairy desserts that have been created using food-grade acidification under different pH levels to coagulate dairy proteins to different extents, in women. These will be compared in a randomised, cross-over, single blinded active control trial. Physiological measures will be used to non-invasively assess the digestive process, alongside biological responses, tracking nutrient appearance, and subjective measures of digestion. Hypothesis: That differences in the structural assemblies present in firm and soft bovine dairy gels (FIRM-G and SOFT-G) arising from the different food processing methods will result in differences in digestion and nutrient delivery.

Interventions

Participants who are female and are self-described as non-allergic to milk will be recruited from the general population. Following informed consent, participants will be randomised to consume on a single morning either 150g firm protein-augmented acid coagulated dairy gel (FIRM-G), produced by acid coagulation at pH 5.6, or 150g soft protein-augmented acid coagulated dairy gel (SOFT-G) within 10 minutes. Adherence will be monitored through ingestion under clinical monitoring. After a wash- out

Participants who are female and are self-described as non-allergic to milk will be recruited from the general population. Following informed consent, participants will be randomised to consume on a single morning either 150g firm protein-augmented acid coagulated dairy gel (FIRM-G), produced by acid coagulation at pH 5.6, or 150g soft protein-augmented acid coagulated dairy gel (SOFT-G) within 10 minutes. Adherence will be monitored through ingestion under clinical monitoring. After a wash- out phase of minimum 3 days, the participants will cross over and receive the other treatment.

Sponsors

Massey University
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

a) Female adult (18-40 years). Female participants will need to declare stage of menstrual cycle during the different study phases, if applicable. b) A BMI between 18 and 30 kg/m2.

Exclusion criteria

• Inability to give informed consent • Known bovine milk allergy • Known significant gastrointestinal disorder (i.e. celiac, IBD, etc.) • Known chronic disease such as diabetes, cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke, self-reported alcohol intake exceeding a moderate intake (>28 units per week) • Current medication use expected to interfere with normal digestive or metabolic processes including proton pump inhibitors, laxatives, antibiotics etc. • Pregnancy, breastfeeding • Unwillingness to comply with the study procedures

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 7, 2026