Dairy and Plant Amino Acid Uptake. An Explorative Study (DaPa)

To optimize the environmental sustainability, a protein transition to more plant-based protein sources is required. However, the protein quality of plant-based sources is lower than that of the dairy proteins casein and whey, which contain high levels of essential amino acids. The amino acid absorption characteristics of many plant-based proteins are unknown.

The present study aims to estimate differences in postprandial plasma total essential amino acids (TEAA) profiles after protein consumption of different protein sources in blood of healthy participants. This explorative study has a randomized, cross-over, double-blind, controlled design.

Study Overview

• Status: Completed
• Conditions: Amino Acid Plasma Profile
• Intervention / Treatment: Dietary supplement: Dairy protein; Dietary supplement: Plant protein

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Wageningen Food & Biobased Research, Food, Health & Consumer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Apparently healthy men and women;
• Age ≥18 and ≤40 years;
• Body mass index (BMI) ≥18.5 and ≤30 kg/m2 ;
• Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).

Exclusion Criteria:

• Any self-reported metabolic, gastrointestinal, inflammatory or chronic disease (such as anemia, diabetes, hepatitis, cardiovascular disease);
• Having a history of medical or surgical events that may significantly affect the study outcome;
• Anaemia (Haemoglobin (Hb) values <7.5 mmol/L for women and <8.5 mmol/L for men), as assessed by finger prick blood during screening visit;
• Having a food or protein allergy
• Use of glucose lowering drugs, insulin;
• Use of medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives);
• Use of antibiotic treatment less than 1 month before start of the study and during the study;
• Use of anti-depressives as a treatment for depression;
• Use of protein supplements (must be stopped 1 week before the first test day);
• Reported weight loss or weight gain of > 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period;
• Reporting to follow or having planned a slimming or medically prescribed diet.
• Not willing to keep a stable lifestyle during the study period;
• Recent blood donation (<1 month prior to test day 1 of the study) or not willing to stop donation during and 1 month after the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dairy protein 1	Dietary supplement: Dairy protein; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
Active Comparator: Dairy protein 2	Dietary supplement: Dairy protein; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
Experimental: Plant protein 1	Dietary supplement: Plant protein; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
Experimental: Plant protein 2	Dietary supplement: Plant protein; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
Experimental: Plant protein 2 + added AA	Dietary supplement: Plant protein; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
Experimental: Plant protein 2 + Dairy protein 2	Dietary supplement: Dairy protein; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.; Dietary supplement: Plant protein; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial blood TEAA profiles	Postprandial plasma total essential amino acids (TEAA) profiles after protein consumption, determined by appearance in blood.	Frome baseline up to 5 hours postprandial

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Collaborators: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Plant protein; Dairy protein; Postprandial plasma amino acid profiles; Essential amino acids (EAA); Total amino acids (AA)
• Other Study ID Numbers: DaPa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No