NCT06045611

Brief Summary

The goal of this interventional study is to learn about the effects of different proteins (from animals or plants) on the metabolism in healthy, normal weight women between 18-45 year who are not on hormonal birth-control. The main questions the study aims to answer are:

  1. 1.How do different proteins affect biological markers of the metabolism and which protein has the strongest effect?
  2. 2.How are the different proteins digested and taken up from our body?

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

October 13, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

September 13, 2023

Last Update Submit

August 11, 2025

Conditions

Keywords

ProteinPlant-based proteinMetabolismSomatotrophic Axis

Outcome Measures

Primary Outcomes (1)

  • Release of Growth Hormone

    The primary outcome is defined as the postprandial release of growth hormone during three hours after oral ingestion of plant-protein test drinks vs. an animal-protein test drink measured as incremental area under the curve. Growth hormone will be measured in blood samples.

    0-3 hours after consumption of test drink (on all 4 study days)

Secondary Outcomes (2)

  • Release of Hormones Related to the Somatotrophic Axis

    0-3 hours after consumption of test drink (on all 4 study days)

  • Kinetics of Amino Acid Uptake

    0-3 hours after consumption of test drink (on all 4 study days)

Study Arms (4)

Isolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/Placebo

EXPERIMENTAL

* Study day 1: 0.6g isolated pea protein/kg/body weight + 400 ml water * Study day 2: 0.6g isolated whey protein/kg/body weight + 400 ml water * Study day 3: 0.6g isolated faba bean protein/kg/body weight + 400 ml water * Study day 4: 400 ml water The fat and energy content of the drinks will be adapted using a plant based oil

Dietary Supplement: Isolated Pea ProteinDietary Supplement: Isolated Whey ProteinDietary Supplement: Isolated Faba Bean ProteinDietary Supplement: Placebo

Isolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean Protein

EXPERIMENTAL

* Study day 1: 0.6g isolated whey protein/kg/body weight + 400 ml water * Study day 2: 400 ml water * Study day 3: 0.6g isolated pea protein/kg/body weight + 400 ml water * Study day 4: 0.6g isolated faba bean protein/kg/body weight + 400 ml water The fat and energy content of the drinks will be adapted using a plant based oil

Dietary Supplement: Isolated Pea ProteinDietary Supplement: Isolated Whey ProteinDietary Supplement: Isolated Faba Bean ProteinDietary Supplement: Placebo

Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey Protein

EXPERIMENTAL

* Study day 1: 0.6g isolated faba bean protein/kg/body weight + 400 ml water * Study day 2: 0.6g isolated pea protein/kg/body weight + 400 ml water * Study day 3: 400 ml water * Study day 4: 0.6g isolated whey protein/kg/body weight + 400 ml water The fat and energy content of the drinks will be adapted using a plant based oil

Dietary Supplement: Isolated Pea ProteinDietary Supplement: Isolated Whey ProteinDietary Supplement: Isolated Faba Bean ProteinDietary Supplement: Placebo

Placebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein

EXPERIMENTAL

* Study day 1: 400 ml water * Study day 2: 0.6g isolated faba bean protein/kg/body weight + 400 ml water * Study day 3: 0.6g isolated whey protein/kg/body weight + 400 ml water * Study day 4: 0.6g isolated pea protein/kg/body weight + 400 ml water The fat and energy content of the drinks will be adapted using a plant based oil

Dietary Supplement: Isolated Pea ProteinDietary Supplement: Isolated Whey ProteinDietary Supplement: Isolated Faba Bean ProteinDietary Supplement: Placebo

Interventions

Isolated Pea ProteinDIETARY_SUPPLEMENT

Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.

Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey ProteinIsolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/PlaceboIsolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean ProteinPlacebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
Isolated Whey ProteinDIETARY_SUPPLEMENT

Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.

Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey ProteinIsolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/PlaceboIsolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean ProteinPlacebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
Isolated Faba Bean ProteinDIETARY_SUPPLEMENT

Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.

Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey ProteinIsolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/PlaceboIsolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean ProteinPlacebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
PlaceboDIETARY_SUPPLEMENT

Participants will consume the placebo in an opaque mug wearing a nose clip.

Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey ProteinIsolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/PlaceboIsolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean ProteinPlacebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females
  • Age: 18-45 years
  • Body mass index: 18.5 \< 25 kg/m2
  • Signed informed consent

You may not qualify if:

  • Use of hormonal contraceptives
  • Pregnancy or breastfeeding
  • Diabetes mellitus or any other metabolic disease that might affect the results of this study
  • Gastric surgery that affects digestion and uptake of protein
  • Any clinically significant present or past disease/condition and medication which in the investigator's opinion could interfere with the results of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University

Örebro, 70182, Sweden

Location

Study Design

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

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

October 13, 2023

Primary Completion

October 24, 2024

Study Completion

September 1, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations