Health TrialsbyHealthPanel

Amino Acids in the Blood After Eating Yoghurt and Milk Proteins

ConditionBioavailability of Amino Acids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorNutricia Research

About this trial

Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order. Participants will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Two blood samples will be taken at baseline and then at 14 timepoints after product intake. A follow up call will take place 7 (-3/+7) days after the final study visit.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 and ≤ 40 years at the time of (Informed Consent Form) ICF signature

Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2

Signed informed consent

Willingness and ability to comply with the protocol

Disqualifiers

Any known surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and/or gastrointestinal (GI) function in the opinion of the investigator, including but not limited to the following: phenylketonuria, pancreatitis, short bowel syndrome, inflammatory bowel disease, celiac disease, gastroesophageal reflux disease, gastric ulcer, chronic gastritis, gastrointestinal cancer, esophageal and/or gastric surgery, and any cardiovascular disease (such as hypertension, arrhythmia, or atrial fibrillation) which is not controlled with the use of medication/therapy.

Known renal or hepatic diseases that may interfere with protein metabolism in the opinion of the investigator, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease.

Use of systemic medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production and/or gastrointestinal motility or function and/or protein metabolism (e.g., antibiotics, anticonvulsants, prokinetics, antacids or gastric acid inhibitors, opioid analgesics, anticoagulants, corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or insulin).

Known Diabetes Mellitus Type I or Type II, insulin resistance, or metabolic syndrome.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Full fat yogurt (fermented)

    Other intervention

    Test

  • Generic full fat pasteurized milk (non-fermented)

    Other intervention

    Control

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Yogurt first, Milk secondActive comparator 2 interventions
Group B: Milk first, Yogurt secondActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B

Time frame
2 hours

Secondary outcomes

1

Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Essential Amino Acids in Blood After Ingestion of Product A or Product B

Time frame
5 hours
2

Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B

Time frame
2 hours
3

Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B

Time frame
5 hours
4

Maximum Concentration (Cmax) of Total Amino Acids and Essential Amino Acids in Blood After Ingestion of Product A or Product B

Time frame
5 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nutricia Research

Lead sponsor

Source ClinicalTrials.gov
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