PAN-Promet: The Effect of Oral Intake of Animal and Plant Proteins on the Metabolism in Healthy Women

Sponsor

Örebro University, Sweden (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06045611

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Isolated Pea Protein Dietary Supplement: Isolated Whey Protein Dietary Supplement: Isolated Faba Bean Protein Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Örebro University	Örebro		Sweden	70182

Sponsors and Collaborators

Örebro University, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Örebro University, Sweden

ClinicalTrials.gov Identifier:

NCT06045611

Other Study ID Numbers:

Dnr 2023-03852-01

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Örebro University, Sweden

Study Results

No Results Posted as of Sep 21, 2023