Post-prandial Glucose in Healthy Indian Subjects
Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Ahemdabad, Indien
- Lambda Therapeutics Research Ltd (LTRL)
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Willing to give consent to participate in the study in writing;
- Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
- Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
- Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
- Willing to comply to study protocol during the study;
- Agreeing to be informed about medically relevant personal test-results by study physician;
- Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
- Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
- Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive)
Exclusion Criteria:
- Being an employee of Unilever or CRO;
- Chronic smokers, tobacco chewers and drinkers;
- Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
- Use of medication which interferes with study measurements including vitamins, tonics;
- Reported intense exercise ≥10 h/week;
- Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
- Blood donation for 2 months prior to screening;
- Urine analysis that showed any drug abuse;
- Allergy to any food or cosmetics;
- If female, not being pregnant or planning pregnancy during the study period;
- If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Andet: Reference food format
reference food format with and without plant-based ingredient added
|
|
|
Eksperimentel: Food format one
Food format one with and without plant-based ingredient added
|
|
|
Eksperimentel: Food format two
Food format two with and without plant-based ingredient added
|
|
|
Eksperimentel: Food format three
Food format three with and without plant-based ingredient added
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Positive incremental post-prandial blood glucose area under the curve
Tidsramme: 120 minutes
|
120 minutes
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Post-prandial insulin area under the curve
Tidsramme: 120 minutes
|
120 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Dr Ketul Modi, MBBS, Lambda Therapeutics Research Ltd (LTRL)
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- FDS-NAA-1373
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