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Post-prandial Glucose in Healthy Indian Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01999543
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Tracking Information
First Submitted Date  ICMJE November 25, 2013
First Posted Date  ICMJE December 3, 2013
Last Update Posted Date February 24, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Positive incremental post-prandial blood glucose area under the curve [ Time Frame: 120 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01999543 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Post-prandial insulin area under the curve [ Time Frame: 120 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-prandial Glucose in Healthy Indian Subjects
Official Title  ICMJE Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects
Brief Summary The study is designed to determine the extent to which a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Dietary Supplement: plant-based dietary supplement
  • Other: Placebo
Study Arms  ICMJE
  • Reference food format
    reference food format with and without plant-based ingredient added
    Interventions:
    • Dietary Supplement: plant-based dietary supplement
    • Other: Placebo
  • Experimental: Food format one
    Food format one with and without plant-based ingredient added
    Interventions:
    • Dietary Supplement: plant-based dietary supplement
    • Other: Placebo
  • Experimental: Food format two
    Food format two with and without plant-based ingredient added
    Interventions:
    • Dietary Supplement: plant-based dietary supplement
    • Other: Placebo
  • Experimental: Food format three
    Food format three with and without plant-based ingredient added
    Interventions:
    • Dietary Supplement: plant-based dietary supplement
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01999543
Other Study ID Numbers  ICMJE FDS-NAA-1373
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Unilever R&D
Study Sponsor  ICMJE Unilever R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Ketul Modi, MBBS Lambda Therapeutics Research Ltd (LTRL)
PRS Account Unilever R&D
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP