- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07795372
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
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
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
- Navn: Wei Xi Khu, B.Sc.
- Telefonnummer: +65 9359 8952
- E-post: E0773498@u.nus.edu
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:
- Wei Xi Khu, B.Sc.
- Telefonnummer: +65 93598952
- E-post: E0773498@u.nus.edu
-
-
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:
- English-literate and able to give informed consent
- Singaporean Adults aged 21 to 45 (inclusive)
- Body mass index of 18.5 to 23.0 kg/m2 (inclusive)
- At least 50 kg
- Healthy (based on screening results)
Exclusion Criteria:
- 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
- High blood pressure (≥ 140/90 mmHg)
- Underlying health conditions that may affect metabolic functions
- 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
- Weight change > 3 kg in the past 3 months
- 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 hours before and on the day of the test visits
- Currently on a specialised diet (e.g., vegetarian, vegan, weight loss diet)
- 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
- Disease or impairment of the 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 pacemaker or related electrical medical devices
- Pregnant, lactating, or planning pregnancy in the next 6 months
- Have donated blood (whole blood or apheresis) or participated in any other clinical study or trial requiring blood draws within the last 3 months
- 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.
Sponsor
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
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
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