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DaPa: Dairy and Plant Amino Acid Uptake. An Explorative Study

Sponsor
FrieslandCampina (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05813769
Collaborator
Wageningen University and Research (Other)
12
Enrollment
1
Location
6
Arms
3
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dairy protein
  • Dietary Supplement: Plant protein
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Dairy and Plant Amino Acid Uptake. An Explorative Study
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Postprandial blood TEAA profiles [Frome baseline up to 5 hours postprandial]

    Postprandial plasma total essential amino acids (TEAA) profiles after protein consumption, determined by appearance in blood.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wageningen Food & Biobased Research, Food, Health & Consumer Research Wageningen Gelderland Netherlands 6708 WG

Sponsors and Collaborators

  • FrieslandCampina
  • Wageningen University and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
FrieslandCampina
ClinicalTrials.gov Identifier:
NCT05813769
Other Study ID Numbers:
  • DaPa
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by FrieslandCampina
Dairy protein
Plant protein
Postprandial plasma amino acid profiles
Essential amino acids (EAA)
Total amino acids (AA)

Study Results

No Results Posted as of Apr 14, 2023