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Effect of Co-consuming Different Dietary Protein Sources With Salad on the Bioavailability of Carotenoids

30. august 2026 oppdatert av: Jung Eun Kim, National University of Singapore

The goal of this clinical trial is to learn if different protein types will affect carotenoid responses in humans when co-consumed with salad. The main questions it aims to answer are:

  • What are the effect of dietary protein co-consumption with salad on postprandial carotenoid levels in Singapore adults?
  • Do different whole-food protein sources enhance the bioavailability of carotenoids in Singapore adults?

Participants will:

Consume salad with a form of protein (chicken, tuna, egg, soybean) Have their postprandial plasma carotenoid and triglyceride outcomes evaluated

Studieoversikt

Detaljert beskrivelse

This study will be a single-blind, randomized, crossover acute trial, and all participants will complete an approximately 3-month study period. A total of 19 participants will be recruited and go through all 5 arms (4 intervention and 1 control), with the order randomized. The study will comprise 1 screening visit and 5 test visits, with another 5 compliance visits.

Studietype

Intervensjonell

Registrering (Antatt)

19

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Singapore, Singapore, 117542
        • NUS, Department of Food Science and Technology, 1 Science Drive 3, Block S13, #03-07, Singapore, 117542
        • Hovedetterforsker:
          • Jung Eun Kim, Ph.D., R.D.
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. English-literate and able to give informed consent
  2. Singaporean Adults aged 21 to 45 (inclusive)
  3. Body mass index of 18.5 to 23.0 kg/m2 (inclusive)
  4. At least 50 kg
  5. Healthy (based on screening results)

Exclusion Criteria:

  1. Currently participating in another clinical study that involves altering regular diet and/or involves consuming a dietary supplement or investigated food product as an intervention
  2. High blood pressure (≥ 140/90 mmHg)
  3. Underlying health conditions that may affect metabolic functions
  4. Consuming carotenoid supplements regularly (i.e., more than three times a week) for the past 3 months, and not willing to discontinue consumption 3 months before and during the study duration
  5. Weight change > 3 kg in the past 3 months
  6. 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)
  7. Current smokers or have quit smoking for less than 5 years
  8. 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)
  9. 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
  10. Not willing to stop consumption of caffeinated beverages 10 to 12 hours before and on the day of the test visits
  11. Currently on a specialised diet (e.g., vegetarian, vegan, weight loss diet)
  12. Had serious food allergies in the past, or having intolerance, sensitivities or allergies to any of the following: soy/soy-derived products, eggs, fish and crustaceans, starch/starch-derived products (e.g., rice, corn, wheat, potato), gluten
  13. Disease or impairment of the liver
  14. Currently diagnosed with diabetes, gastrointestinal issues (e.g., lactose intolerance, irritable bowel syndrome), gout and/or G6PD deficiency
  15. Taking antibiotics 2 weeks prior to study participation
  16. Taking anti-hypertensive or cholesterol-lowering drugs for less than 3 years unless medically declared by an official doctor to be in stable condition
  17. Poor peripheral venous access based on past experiences with blood drawing
  18. Individuals with pacemaker or related electrical medical devices
  19. Pregnant, lactating, or planning pregnancy in the next 6 months
  20. Have donated blood (whole blood or apheresis) or participated in any other clinical study or trial requiring blood draws within the last 3 months
  21. Clinical anemia (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Salad only
Salad only (no protein)
Control group, consumption of only salad
Eksperimentell: Salad + Chicken
Salad with chicken
Consumption of salad with chicken
Eksperimentell: Salad + Tuna
Salad with tuna
Consumption of salad with tuna
Eksperimentell: Salad + Egg
Salad with egg
Consumption of salad with egg
Eksperimentell: Salad + Soybean
Salad with soybeans
Consumption of salad with soybean

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concentration of plasma carotenoids
Tidsramme: From start of salad consumption to the end of acute period (8 hours)
Concentration of plasma carotenoids hourly
From start of salad consumption to the end of acute period (8 hours)
Concentration of blood triglycerides
Tidsramme: From start of salad consumption to the end of acute period (8 hours)
Postprandial triglyceride response
From start of salad consumption to the end of acute period (8 hours)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jung Eun Kim, Ph.D., R.D., National University of Singapore, Department of Food Science and Technology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

26. august 2026

Først innsendt som oppfylte QC-kriteriene

26. august 2026

Først lagt ut (Faktiske)

31. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • S37
  • NUS-IRB-2026-590 (Annen identifikator: National University of Singapore Institutional Review Board (NUS IRB))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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