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Trial record 12 of 3091 for:    Area Under Curve AND Healthy

Post-prandial Glucose in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01955447
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
The study is designed to determine the extent to which foods containing different levels of plant-based ingredients affect blood glucose responses in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Dietary Supplement: no added plant-based ingredients to starchy meal Dietary Supplement: Low level plant-based ingredients added to starchy meal Dietary Supplement: Medium level plant-based ingredients added to starchy meal Dietary Supplement: High level plant-based ingredients added to starchy meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Different Levels of Plant-based Ingredients on Post-prandial Glucose in Healthy Subjects
Study Start Date : November 2013
Actual Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Placebo Comparator: Reference
no added plant-based ingredients
Dietary Supplement: no added plant-based ingredients to starchy meal
no added plant-based ingredients to starchy meal

Active Comparator: Low level plant-based ingredients
Low level addition of plant-based ingredients
Dietary Supplement: Low level plant-based ingredients added to starchy meal
Low level plant-based ingredients added to starchy meal

Active Comparator: Medium level plant-based ingredients
Medium level addition of plant-based ingredients
Dietary Supplement: Medium level plant-based ingredients added to starchy meal
Medium level plant-based ingredients added to starchy meal

Active Comparator: High level plant-based ingredients
High level addition of plant-based ingredients
Dietary Supplement: High level plant-based ingredients added to starchy meal
High level plant-based ingredients added to starchy meal




Primary Outcome Measures :
  1. Post-prandial blood glucose area under the curve [ Time Frame: 120 minutes ]

Secondary Outcome Measures :
  1. Post-prandial insulin area under the curve [ Time Frame: 120 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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) as judged by the research physician.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955447


Locations
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India
Lambda Therapeutics Research Ltd (LTRL)
Ahmedabad, India
Sponsors and Collaborators
Unilever R&D
Investigators
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Principal Investigator: Dr Ketul Modi, MBBS Lambda Therapeutics Research Ltd (LTRL)

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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01955447     History of Changes
Other Study ID Numbers: FDS-NAA-1335
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: November 2013

Keywords provided by Unilever R&D:
Blood glucose