Dairy and Plant Amino Acid Uptake. An Explorative Study (DaPa)
June 23, 2023 updated by: FrieslandCampina
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6708 WG
- Wageningen Food & Biobased Research, Food, Health & Consumer Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dairy protein 1
|
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
|
|
Active Comparator: Dairy protein 2
|
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
|
|
Experimental: Plant protein 1
|
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
|
|
Experimental: Plant protein 2
|
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
|
|
Experimental: Plant protein 2 + added AA
|
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
|
|
Experimental: Plant protein 2 + Dairy protein 2
|
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
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
Time Frame: Frome baseline up to 5 hours postprandial
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.