NCT05401591

Brief Summary

Protein is an essential part of the human diet. But with a growing global population and climate emergency, current sources of dietary protein are unable to continue to sustainably meet the global demand. To ensure future food security, new sustainable protein sources are required. Microalgae - a group of plant-like single cells - are thought to be a good option due to their sustainable farming methods and naturally high protein content. Long term health benefits of eating microalgae have been seen in humans. However, the time directly following microalgae ingestion has not been well studied but is an important period when considering a protein source. This research will compare the period after ingestion of three preparations and/or types of microalgae to a traditional source of protein.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 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

August 28, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

May 26, 2022

Last Update Submit

April 22, 2024

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (1)

  • Plasma amino acids

    Amino acid concentrations measured in participant plasma following the ingestion of protein drinks.

    5 hours postprandial

Study Arms (4)

Milk protein

ACTIVE COMPARATOR
Dietary Supplement: Protein shake

Whole cell chlorella

EXPERIMENTAL
Dietary Supplement: Protein shake

Cracked cell chlorella

EXPERIMENTAL
Dietary Supplement: Protein shake

Spirulina

EXPERIMENTAL
Dietary Supplement: Protein shake

Interventions

Protein shakeDIETARY_SUPPLEMENT

Participant will drink a protein shake made using each of the four protein types.

Cracked cell chlorellaMilk proteinSpirulinaWhole cell chlorella

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5 -30 kg/m2
  • age 18 - 40 years
  • healthy
  • non-smoker

You may not qualify if:

  • BMI \<18.5 or \>30 kg/m2
  • smoker
  • metabolic disease
  • relevant food intolerance
  • using medications known to affect metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exeter University

Exeter, United Kingdom

Location

Study Design

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

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 2, 2022

Study Start

August 28, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)