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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Isolated Pea Protein
* Dietary Supplement: Isolated Whey Protein
* Dietary Supplement: Isolated Faba Bean Protein
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention 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<br>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<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Whey Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Faba Bean Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Placebo<br>* Participants will consume the placebo in an opaque mug wearing a nose clip.<br>|
| Experimental: Isolated Whey Protein/Placebo/Isolated Pea Protein/Isolated Faba Bean Protein<br>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<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Whey Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Faba Bean Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Placebo<br>* Participants will consume the placebo in an opaque mug wearing a nose clip.<br>|
| Experimental: Isolated Faba Bean Protein/Isolated Pea Protein/Placebo/Isolated Whey Protein<br>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<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Whey Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Faba Bean Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Placebo<br>* Participants will consume the placebo in an opaque mug wearing a nose clip.<br>|
| Experimental: Placebo/Isolated Faba Bean Protein/Isolated Whey Protein/Isolated Pea Protein<br>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<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Whey Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Isolated Faba Bean Protein<br>* Participants will consume the protein supplement dissolved in water in an opaque mug wearing a nose clip.<br>Dietary Supplement: Placebo<br>* Participants will consume the placebo in an opaque mug wearing a nose clip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein, Plant-based protein, Metabolism, Somatotrophic Axis