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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04297137
Other study ID # 191023/A/09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 12, 2019
Est. completion date October 1, 2022

Study information

Verified date January 2024
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Protein ingestion
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.

Locations

Country Name City State
United Kingdom University of Exeter Exeter

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma amino acid concentrations Peak and total plasma amino acid concentrations following protein ingestion 5 hours
Secondary Blood glucose The levels of glucose in the blood following protein ingestion 5 hours
Secondary Serum insulin The levels of insulin in blood serum following protein ingestion 5 hours
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