- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07791420
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
Not yet recruiting
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
Interventional
Enrollment (Estimated)
20
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 Contact
- Name: Marven Ng, B.Sc.
- Phone Number: (+65) 8816 9977
- Email: ngmarven@u.nus.edu
Study Locations
-
-
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Singapore, Singapore
- NUS, Department of Food Science and Technology, 1 Science Drive 3, Block S13, #03-07, Singapore, 117550
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Principal Investigator:
- Jung Eun Kim, Ph.D., R.D.
-
Contact:
- Marven Ng, B.Sc.
- Phone Number: (+65) 8816 9977
- Email: ngmarven@u.nus.edu
-
-
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
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of bead-milled microalgae
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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
|
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
|
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
|
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
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Consume a 400 mL drink containing maltodextrin matched for the energy content of 20 g protein
|
What is the study measuring?
Primary Outcome Measures
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)
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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
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Targeted metabolomics profiling of urine will be conducted liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)
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Baseline and 300 minutes
|
Secondary Outcome Measures
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
Investigators
- 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.
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)
September 1, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
August 19, 2026
First Submitted That Met QC Criteria
August 25, 2026
First Posted (Actual)
August 28, 2026
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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