- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05401591
Microalgae as an Alternative Protein Source in Human Nutrition. (MAPS)
April 22, 2024 updated by: University of Exeter
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Exeter, United Kingdom
- Exeter University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- BMI 18.5 -30 kg/m2
- age 18 - 40 years
- healthy
- non-smoker
Exclusion Criteria:
- BMI <18.5 or >30 kg/m2
- smoker
- metabolic disease
- relevant food intolerance
- using medications known to affect metabolism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Milk protein
|
Participant will drink a protein shake made using each of the four protein types.
|
Experimental: Whole cell chlorella
|
Participant will drink a protein shake made using each of the four protein types.
|
Experimental: Cracked cell chlorella
|
Participant will drink a protein shake made using each of the four protein types.
|
Experimental: Spirulina
|
Participant will drink a protein shake made using each of the four protein types.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma amino acids
Time Frame: 5 hours postprandial
|
Amino acid concentrations measured in participant plasma following the ingestion of protein drinks.
|
5 hours postprandial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2021
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (Actual)
June 2, 2022
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 21-07-14-A-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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