Measurement of Acute Metabolite Changes Following Consumption of Microalgae Drinks

August 28, 2026 updated by: Jung Eun Kim, National University of Singapore

Measurement of Acute Metabolite Changes Following Consumption of Unprocessed and Processed Microalgae: A Randomized Crossover Trial

Protein consumption is essential for various physiological processes, with microalgae and plant proteins gaining increasing attention due to their health benefits. To better understand how different protein types and processing methods impact health outcomes, this study aims to analyse the metabolite changes in response to different protein sources.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomised crossover trial involving 16 participants. It comprises one screening visit and five test visits, during which participants will consume intervention drinks containing primarily (1) maltodextrin, (2) whey protein isolate, (3) soy protein isolate, (4) bead-milled microalgae, or (5) non-bead-milled microalgae in a randomised order. The study aims to investigate and compare acute postprandial metabolite responses following the consumption of bead-milled and non-bead-milled microalgae, as well as whey and soy protein isolates, in Singaporean adults.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • Singapore, Singapore
        • NUS, Department of Food Science and Technology, 1 Science Drive 3, Block S13, #03-07, Singapore, 117550
        • Principal Investigator:
          • Jung Eun Kim, Ph.D., R.D.
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English-literate and able to give informed consent
  • Singaporean Chinese Adults aged 21 to 60 (inclusive)
  • Body mass index of 18.5 to 23.0 kg/m^2 (inclusive)
  • Healthy (Based on results from screening session)

Exclusion Criteria:

  • Currently participating in another clinical study that involves altering the regular diet and/or involves consuming a dietary supplement or investigated food product as an intervention
  • High blood pressure (≥ 140/90 mmHg)
  • Underlying health conditions that may affect metabolic functions
  • Consuming amino acid or protein supplements, or protein drinks, regularly (i.e., more than three times a week) for the past 3 months, and not willing to discontinue usage 3 months before and during the study duration
  • Weight change > 3 kg in the past 3 months
  • Weight < 50 kg
  • Exercising vigorously over the past 3 months (i.e., engaging in high-intensity exercises for more than 3 hours a week, where high-intensity exercises leave one out of breath and unable to talk or sing during the workout)
  • Current smokers or have quit smoking for less than 5 years
  • Drinking > 2 alcoholic drinks per day (i.e., one drink is defined as either 150 ml of wine, 340 ml of beer/cider or 45 ml of distilled spirit)
  • If drinking ≤ 2 alcoholic drinks per day, not willing to stop consumption of alcoholic beverages two days before and on the day of the test visits
  • Not willing to stop consumption of caffeinated beverages 10 to 12 houFrs before and on the day of the test visits
  • Currently on a specialised diet (e.g., Halal, vegetarian, vegan, weight loss diet)
  • Had serious food allergies in the past, or having intolerance, sensitivities or allergies to any of the following: seaweed or algae and their derived products, milk/dairy products (e.g., whey), starch/starch-derived products (e.g., rice, corn, wheat, potato), soy/soy-derived products, gluten, eggs, nuts, peanuts, fish and crustaceans
  • Disease or impairment of the kidney and/or liver*
  • Currently diagnosed with diabetes*, gastrointestinal issues (e.g., lactose intolerance, irritable bowel syndrome), gout and/or G6PD deficiency
  • Taking antibiotics 2 weeks prior to study participation
  • Taking anti-hypertensive or cholesterol-lowering drugs for less than 3 years unless medically declared by an official doctor to be in stable condition
  • Poor peripheral venous access based on past experiences with blood drawing
  • Individuals with anemia and/or blood clotting disorders
  • Donated blood within the 12 weeks prior to study participation
  • Individuals with pacemaker or related electrical medical devices
  • Pregnant, lactating, or planning pregnancy in the next 6 months

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of bead-milled microalgae
Dietary supplement: Bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of bead-milled microalgae
Active Comparator: Non-bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of non-bead-milled microalgae
Dietary supplement: Non-bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of non-bead-milled microalgae
Active Comparator: Whey protein isolate
Consume a 400 mL drink containing 20 g protein equivalent of whey protein isolate
Dietary supplement: Whey protein isolate
Consume a 400 mL drink containing 20 g protein equivalent of whey protein isolate
Active Comparator: Soy Protein Isolate
Consume a 400 mL drink containing 20 g protein equivalent of soy protein isolate
Dietary supplement: Soy protein isolate
Consume a 400 mL drink containing 20 g protein equivalent of soy protein isolate
Placebo Comparator: Maltodextrin
Consume a 400 mL drink containing maltodextrin matched for the energy content of 20 g protein
Dietary supplement: Maltodextrin (Placebo)
Consume a 400 mL drink containing maltodextrin matched for the energy content of 20 g protein

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in metabolites found in plasma (plasma metabolomics)
Time Frame: Baseline, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes
Targeted metabolomics profiling of plasma will be conducted using liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)
Baseline, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes
Changes in metabolites found in urine (urinary metabolomics)
Time Frame: Baseline and 300 minutes
Targeted metabolomics profiling of urine will be conducted liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)
Baseline and 300 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Appetite
Time Frame: Baseline, 60, 120, 180, 240, 300 minutes
The Appetite Visual Analogue Scale (VAS) questionnaire will be administered, with participants rating five appetite-related outcomes, i.e. desire to eat, hunger, fullness, satisfaction, and prospective food consumption. Each response will be measured on a 100-mm visual analogue scale and scored from 0 to 100, with higher scores indicate a greater intensity of the outcomes being assessed, i.e. greater desire to eat, greater hunger, greater fullness, greater satisfaction, or a greater perceived amount of food that could be consumed.
Baseline, 60, 120, 180, 240, 300 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jung Eun Kim, Ph.D., R.D., National University of Singapore, Department of Food Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S38
  • NUS-IRB-2026-444 (Other Identifier: National University of Singapore Institutional Review Board (NUS IRB))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Electronic copies of the data with identifiable participant information will be kept on NUS OneDrive with access limited only to A/P Kim Jung Eun and her research staff. All data will be de-identified prior to statistical analyses.

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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