The Muscle Protein Synthetic Response of Algal and Fungal... | NCT05016557

Studies
The Muscle Protein Synthetic Response of Algal and Fungal Protein

NCT05016557

Sponsor

University of Exeter

Status

Completed

Last Update Posted

Jan 11, 2024Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Muscle Metabolism

Interventions

Protein ingestion

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2020Actual

Primary Completion Date

Jun 24, 2022Actual

Completion Date

Jun 24, 2022Actual

First Submitted Date

Aug 17, 2021

First Submission Date that Met QC Criteria

Aug 17, 2021

First Posted Date

Aug 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2024

Last Update Posted Date

Jan 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Dietary protein intake is vital for the maintenance of skeletal muscle mass and health. The production of animal-based proteins sources is associated with growing environmental and ethical challenges. As such, sustainable alternatives are needed. Algae are sustainably produced high-protein sources and it is predicted that algae will become one of the most consumed proteins in the next decades. However, the effects of algae on the stimulation of muscle mass growth are unknown. Therefore, we aim to assess the rate of digestion and absorption, and the effects on muscle growth of two types of algae (spirulina and chlorella) when compared to a sustainable non-animal derived fungal reference protein (mycoprotein), a source known to elicit a robust anabolic response.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mycoprotein	Experimental	Bolus ingestion of mycoprotein providing 25g protein	Dietary Supplement: Protein ingestion
Spirulina	Experimental	Bolus ingestion of spirulina providing 25g protein	Dietary Supplement: Protein ingestion
Chlorella	Experimental	Bolus ingestion of chlorella providing 25g protein	Dietary Supplement: Protein ingestion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein ingestion	Dietary Supplement	Bolus ingestion of 25g protein	Chlorella Mycoprotein Spirulina

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle Protein Synthesis	The rate of synthesis of new muscle protein (Fractional Synthetic Rate %/h)	7.5 hours

Secondary Outcomes

Measure	Description	Time Frame
Plasma Amino Acid Kinetics	The rate of appearance of amino acid ingested in the drink	7.5 hours
Serum Insulin	Basal and postprandial concentrations of serum insulin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI between 18.5 and 30
Recreationally active (<3 times per week structured resistance exercise training)

Exclusion Criteria:

Any metabolic impairment
Any cardiovascular impairment
High blood pressure (>140/90 mmHg)
A personal history of epilepsy, seizures or schizophrenia
Smoking
Chronic (>1 month) use of over the counter pharmaceuticals
Chronic (>2 months) use of amino acid or protein supplements
Allergic to Quorn/mycoprotein or algae products

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin T Wall, PhD	Professor of Nutritional Physiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Exeter		Exeter	Devon	EX1 2LU	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided