- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07791420
Measurement of Acute Metabolite Changes Following Consumption of Microalgae Drinks
28. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Marven Ng, B.Sc.
- Telefonnummer: (+65) 8816 9977
- E-mail: ngmarven@u.nus.edu
Studiesteder
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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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Ledende efterforsker:
- Jung Eun Kim, Ph.D., R.D.
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Kontakt:
- Marven Ng, B.Sc.
- Telefonnummer: (+65) 8816 9977
- E-mail: ngmarven@u.nus.edu
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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
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Aktiv komparator: Non-bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of non-bead-milled microalgae
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Consume a 400 mL drink containing 20 g protein equivalent of non-bead-milled microalgae
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Aktiv komparator: Whey protein isolate
Consume a 400 mL drink containing 20 g protein equivalent of whey protein isolate
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Consume a 400 mL drink containing 20 g protein equivalent of whey protein isolate
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Aktiv komparator: Soy Protein Isolate
Consume a 400 mL drink containing 20 g protein equivalent of soy protein isolate
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Consume a 400 mL drink containing 20 g protein equivalent of soy protein isolate
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Placebo komparator: 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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in metabolites found in plasma (plasma metabolomics)
Tidsramme: Baseline, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes
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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
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Changes in metabolites found in urine (urinary metabolomics)
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Appetite
Tidsramme: 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.
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Baseline, 60, 120, 180, 240, 300 minutes
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jung Eun Kim, Ph.D., R.D., National University of Singapore, Department of Food Science and Technology
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
31. august 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
19. august 2026
Først indsendt, der opfyldte QC-kriterier
25. august 2026
Først opslået (Faktiske)
28. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S38
- NUS-IRB-2026-444 (Anden identifikator: National University of Singapore Institutional Review Board (NUS IRB))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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