NCT04297137

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

2.9 years

First QC Date

March 3, 2020

Last Update Submit

January 10, 2024

Conditions

Keywords

Protein digestionAmino acid absorptionBioavailability

Outcome Measures

Primary Outcomes (1)

  • Plasma amino acid concentrations

    Peak and total plasma amino acid concentrations following protein ingestion

    5 hours

Secondary Outcomes (2)

  • Blood glucose

    5 hours

  • Serum insulin

    5 hours

Study Arms (6)

Mycoprotein

EXPERIMENTAL

Ingestion of 30 g mycoprotein drink

Dietary Supplement: Protein ingestion

Spirulina

EXPERIMENTAL

Ingestion of 30 g spirulina protein drink

Dietary Supplement: Protein ingestion

Chlorella

EXPERIMENTAL

Ingestion of 30 g chlorella protein drink

Dietary Supplement: Protein ingestion

Pea

EXPERIMENTAL

Ingestion of 30 g pea protein drink

Dietary Supplement: Protein ingestion

Lupin

EXPERIMENTAL

Ingestion of 30 g lupin protein drink

Dietary Supplement: Protein ingestion

Milk

ACTIVE COMPARATOR

Ingestion of 30 g milk protein

Dietary Supplement: Protein ingestion

Interventions

Protein ingestionDIETARY_SUPPLEMENT

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

ChlorellaLupinMilkMycoproteinPeaSpirulina

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18-35 or 55 - 80 years old.
  • Body mass index between 18.5 - 30.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, United Kingdom

Location

Study Officials

  • Benjamin T Wall, PhD

    Professor of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

November 12, 2019

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations