Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

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

Studiesteder

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

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
Eksperimentel: Bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of bead-milled microalgae
Aktiv komparator: 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
Aktiv komparator: 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
Aktiv komparator: 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 komparator: Maltodextrin
Consume a 400 mL drink containing maltodextrin matched for the energy content of 20 g protein
Consume a 400 mL drink containing maltodextrin matched for the energy content of 20 g protein

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in metabolites found in plasma (plasma metabolomics)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Baseline, 60, 120, 180, 240, 300 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

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

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner