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OpenTrials
Completed

NCT Number: NCT04297137

The Bioavailability of Multiple Novel, Sustainable, Non-animal Derived Protein Sources

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein ingestion

Dietary Supplement

Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.

Primary outcomes

  1. Plasma amino acid concentrations

    Time frame: 5 hours

    Peak and total plasma amino acid concentrations following protein ingestion

Secondary outcomes

  1. Blood glucose

    Time frame: 5 hours

    The levels of glucose in the blood following protein ingestion

  2. Serum insulin

    Time frame: 5 hours

    The levels of insulin in blood serum following protein ingestion

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Official study title

Comparing the Bioavailability of the Sustainable, Non-animal Derived Protein Sources Mycoprotein, Spirulina, Chlorella, Pea and Lupin to Milk Protein in Healthy Older Adults

Acronym: NOVA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2020
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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