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OpenTrials
Completed

NCT Number: NCT02218528

Effect of a Plant-based Ingredient on Glucose Response

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lambda Therapeutics Research Ltd (LTRL)

Ahmedabad, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plant-based ingredient

Dietary Supplement

No plant-based ingredient

Dietary Supplement

Primary outcomes

  1. Positive incremental post-prandial blood glucose area unde the curve

    Time frame: 120 minutes

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 18, 2014
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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