NCT05813769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

May 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

March 27, 2023

Last Update Submit

June 23, 2023

Conditions

Amino Acid Plasma Profile

Keywords

Dairy proteinPlant proteinPostprandial plasma amino acid profilesEssential amino acids (EAA)Total amino acids (AA)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Dairy protein 1

ACTIVE COMPARATOR
Dietary Supplement: Dairy protein

Dairy protein 2

ACTIVE COMPARATOR
Dietary Supplement: Dairy protein

Plant protein 1

EXPERIMENTAL
Dietary Supplement: Plant protein

Plant protein 2

EXPERIMENTAL
Dietary Supplement: Plant protein

Plant protein 2 + added AA

EXPERIMENTAL
Dietary Supplement: Plant protein

Plant protein 2 + Dairy protein 2

EXPERIMENTAL
Dietary Supplement: Dairy proteinDietary Supplement: Plant protein

Interventions

Dairy proteinDIETARY_SUPPLEMENT

During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.

Dairy protein 1Dairy protein 2Plant protein 2 + Dairy protein 2
Plant proteinDIETARY_SUPPLEMENT

During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.

Plant protein 1Plant protein 2Plant protein 2 + Dairy protein 2Plant protein 2 + added AA

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen Food & Biobased Research, Food, Health & Consumer Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

MeSH Terms

Interventions

Plant Proteins

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 14, 2023

Study Start

May 9, 2023

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

NL(1)