- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06045611
The Effect of Oral Intake of Animal and Plant Proteins on the Metabolism in Healthy Women (PAN-Promet)
The Effect of Oral Ingestion of Animal and Plant-based Proteins on the Somatotropic Axis
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:
- How do different proteins affect biological markers of the metabolism and which protein has the strongest effect?
- 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Örebro, Sweden, 70182
- Örebro University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Isolated Pea Protein/Isolated Whey Protein/Isolated Faba Bean Protein/Placebo
The fat and energy content of the drinks will be adapted using a plant based oil |
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the placebo in an opaque mug wearing a nose clip.
|
|
Experimental: Isolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean Protein
The fat and energy content of the drinks will be adapted using a plant based oil |
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the placebo in an opaque mug wearing a nose clip.
|
|
Experimental: Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey Protein
The fat and energy content of the drinks will be adapted using a plant based oil |
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the placebo in an opaque mug wearing a nose clip.
|
|
Experimental: Placebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein
The fat and energy content of the drinks will be adapted using a plant based oil |
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.
Participants will consume the placebo in an opaque mug wearing a nose clip.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Release of Growth Hormone
Time Frame: 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.
|
0-3 hours after consumption of test drink (on all 4 study days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Release of Hormones Related to the Somatotrophic Axis
Time Frame: 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.
|
0-3 hours after consumption of test drink (on all 4 study days)
|
|
Kinetics of Amino Acid Uptake
Time Frame: 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.
|
0-3 hours after consumption of test drink (on all 4 study days)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Dnr 2023-03852-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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