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

Healthy Clinical Trial

— PAN-Promet  

Official title:

The Effect of Oral Ingestion of Animal and Plant-based Proteins on the Somatotropic Axis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06045611
• Other study ID #: Dnr 2023-03852-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Isolated Pea Protein
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
• Isolated Whey Protein
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
• Isolated Faba Bean Protein
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
• Placebo
Participants will consume the placebo in an opaque mug wearing a nose clip.

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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