The Effect of Oral Intake of Animal and Plant Proteins on the Metabolism in Healthy Women

Not Applicable

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT06045611
• Lead Sponsor: Örebro University, Sweden

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. How do different proteins affect biological markers of the metabolism and which protein has the strongest effect?

2. How are the different proteins digested and taken up from our body?

Participants will drink four different shakes on four different study days in a random order. Three of them contain each a different protein and one does not contain protein. Right before drinking the shake and on 11 timepoints after drinking the shake blood samples will be drawn.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Study Start: 2023-10-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Release of Growth Hormone	0-3 hours after consumption of test drink (on all 4 study days)	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.

Secondary Outcome Measures

Name	Time	Method
Release of Hormones Related to the Somatotrophic Axis	0-3 hours after consumption of test drink (on all 4 study days)	We will measure different hormones related to the somatotrophin axis in collected blood samples and investigate if there are differences between different protein-sources.
Kinetics of Amino Acid Uptake	0-3 hours after consumption of test drink (on all 4 study days)	We will measure amino acids in collected blood samples to investigate dynamics and kinetics of protein digestion/uptake of different protein sources.

Trial Locations

Locations (1)

Örebro University; 🇸🇪 Örebro, Sweden