- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04297137
The Bioavailability of Multiple Novel, Sustainable, Non-animal Derived Protein Sources (NOVA)
Comparing the Bioavailability of the Sustainable, Non-animal Derived Protein Sources Mycoprotein, Spirulina, Chlorella, Pea and Lupin to Milk Protein in Healthy Older Adults
The progressive age-related loss of muscle mass is termed sarcopenia. Consequences of sarcopenia are, but not limited to, decreased muscle strength, frailty, and an increased risk for the development of chronic metabolic diseases. Impaired postprandial protein digestion and amino acid absorption with advancing age has been suggested to be a key mechanism underlying sarcopenia. To overcome age-related skeletal muscle atrophy, sufficient dietary protein intake is required. However, the production of animal-based protein sources, such as milk, is associated with a number of economic, environmental, and ethical issues. Accordingly, there is a need to develop sustainable dietary protein sources to support our nutrition. Mycoprotein, spirulina, chlorella, pea, and lupin are novel, sustainable, non-animal derived protein sources that may represent potential alternative protein sources. However, the efficacy of these sources to stimulate muscle mass growth in both young and older adults is unknown.
Therefore, the present study will investigate the postprandial bioavailability of mycoprotein, spirulina, chlorella, pea, and lupin protein when compared to the animal-derived milk protein. Moreover, postprandial protein handling of these novel protein sources across different ages will be assessed. Briefly, 12 healthy young, and older adults will visit the University for 6 separate test days, with each day lasting 6 hours. Participants will consume the one of the 6 protein drinks on each test day. Repeated blood sampling will be used to assess protein digestion and subsequent systemic amino acid appearance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Exeter, United Kingdom
- University of Exeter
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females aged 18-35 or 55 - 80 years old.
- Body mass index between 18.5 - 30.
Exclusion Criteria:
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).
- Any diagnosed cardiovascular disease or hypertension.
- Elevated blood pressure (>150/90 mmHg) at the time of screening.
- Known pre-existing liver disease/condition.
- Any medication known to affect protein and/or amino acid metabolism.
- Allergy to mycoprotein/Quorn/edible fungi, edible algae, lupin/legumes, or milk.
- Smoking.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mycoprotein
Ingestion of 30 g mycoprotein drink
|
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
|
|
Experimental: Spirulina
Ingestion of 30 g spirulina protein drink
|
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
|
|
Experimental: Chlorella
Ingestion of 30 g chlorella protein drink
|
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
|
|
Experimental: Pea
Ingestion of 30 g pea protein drink
|
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
|
|
Experimental: Lupin
Ingestion of 30 g lupin protein drink
|
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
|
|
Active Comparator: Milk
Ingestion of 30 g milk protein
|
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma amino acid concentrations
Time Frame: 5 hours
|
Peak and total plasma amino acid concentrations following protein ingestion
|
5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: 5 hours
|
The levels of glucose in the blood following protein ingestion
|
5 hours
|
|
Serum insulin
Time Frame: 5 hours
|
The levels of insulin in blood serum following protein ingestion
|
5 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benjamin T Wall, PhD, Professor of Nutritional Physiology
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
- 191023/A/09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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