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Effect of a Plant-based Ingredient on Glucose Response

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: NCT02218528
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Plant-based ingredient Dietary Supplement: No Plant-based ingredient Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: An Exploratory Study of a Plant-based Ingredient for Reducing the Post-prandial Blood Glucose Response in Healthy Indian Adults, When Administered With a Meal
Study Start Date : August 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Placebo Comparator: Starchy meal
No Plant-based ingredient added to a starchy meal
Dietary Supplement: No Plant-based ingredient
Active Comparator: Low dose added to starchy meal
Plant-based ingredient in low dose added to starchy meal
Dietary Supplement: Plant-based ingredient
Placebo Comparator: Starchy meal and side dish
No Plant-based ingredient added to starchy meal and side dish
Dietary Supplement: No Plant-based ingredient
Active Comparator: Low dose added to starchy meal and side dish
Plant-based ingredient in low dose added to starchy meal and side dish
Dietary Supplement: Plant-based ingredient
Active Comparator: Medium dose added to starchy meal and side dish
Plant-based ingredient in medium dose added to starchy meal and side dish
Dietary Supplement: Plant-based ingredient
Active Comparator: High dose added to starchy meal and side dish
Plant-based ingredient in high dose added to starchy meal and side dish
Dietary Supplement: Plant-based ingredient



Primary Outcome Measures :
  1. Positive incremental post-prandial blood glucose area unde the curve [ Time Frame: 120 minutes ]

Secondary Outcome Measures :
  1. Positive incremental post-prandial blood glucose area under the curve [ Time Frame: 180 minutes ]
  2. Post-prandial insulin response [ Time Frame: 120 minutes ]
  3. Post-prandial insulin response [ Time Frame: 180 minutes ]
  4. Assessment of gastric emptying rate [ Time Frame: 10 hours ]
    GE50% (time to empty 50% of the gastric content) will be determined with paracetamol


Other Outcome Measures:
  1. Cmax [ Time Frame: 120 minutes ]
    peak plasma glucose

  2. Cmax-baseline corrected [ Time Frame: 120 minutes ]
    peak plasma glucose - baseline plasma glucose

  3. Tmax [ Time Frame: 120 minutes ]
    peak time plasma glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
  • Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
  • Fasting blood glucose value of subjects 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;
  • Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
  • Agreeing to be informed about medically relevant personal test-results by study physician;
  • Willing to comply to study protocol during study;
  • Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
  • Accessible veins on arms as determined by examination at screening;
  • Being literate;
  • HbA1C ≤ 6.5 % (48 mmol/mol).

Exclusion Criteria:

  • Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
  • Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
  • Blood donation in the past 2 months;
  • Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
  • Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between 23.00 PM and 6.00 AM;
  • Reported intense sporting activities > 10h/w;
  • Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;
  • Drug abuse as indicated by urine analysis;
  • Chronic smokers, tobacco chewers and drinkers;
  • Use of any medication, including supplements and traditional medicine;
  • Reported dietary habits, such as a medically prescribed/slimming diet;
  • Not being used to eat breakfast;
  • Reported weight loss/gain (>10%) in the last six month before the study;
  • Being an employee of Unilever or CRO;
  • Allergy or intolerance to food products and aversion to food products provided during the study;
  • If female: pregnant or will be planning pregnancy during the study period;
  • If female: lactating or has been lactating in the 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): NCT02218528


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: NCT02218528    
Other Study ID Numbers: FDS-NAA-1716
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: August 2014
Keywords provided by Unilever R&D:
subjects