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OpenTrials
Completed

NCT Number: NCT01999543

Post-prandial Glucose in Healthy Indian Subjects

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

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lambda Therapeutics Research Ltd (LTRL)

Ahemdabad, India

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

plant-based dietary supplement

Dietary Supplement

Placebo

Other

Primary outcomes

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

    Time frame: 120 minutes

Secondary outcomes

  1. Post-prandial insulin area under the curve

    Time frame: 120 minutes

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2013
Registry last updated
Feb 24, 2014

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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