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Completed

NCT Number: NCT02256332

Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes

Effects of a plant based ingredient on blood glucose in Type II diabetes patients.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA, Thane, Maharashtra, India

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About this study

The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
  • Age ≥ 20 and ≤ 65 year at screening;
  • Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
  • HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c >53 mmol/mol and <58 mmol/mol (>7.0% and < 7.5%) controlled solely through diet and exercise are also allowed to participate.

Exclusion criteria

  • Being an employee of Unilever or research site;
  • Chronic smokers, tobacco chewers and drinkers;
  • No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
  • Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
  • 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

Low dose plant based ingredient

Dietary Supplement

Reference food with low dose of plant based ingredient

High dose plant based ingredient

Dietary Supplement

Reference food with high dose of plant based ingredient

Reference food format

Dietary Supplement

Reference food without plant-based ingredient

Primary outcomes

  1. Post prandial blood glucose positive incremental area under the curve

    Time frame: 120 minutes

Secondary outcomes

  1. Post prandial insulin area under the curve

    Time frame: 120 minutes

Other outcomes

  1. Post prandial blood glucose positive incremental area under the curve

    Time frame: 180 and 240 minutes

  2. Post prandial insulin area under the curve

    Time frame: 180 and 240 minutes

  3. Glucose levels in urine

    Time frame: 240 minutes

  4. Intestinal discomfort

    Time frame: 240 minutes

    Intestinal discomfort will be evaluated by a paper and pen questionnaire in the subject's native language directed to intestinal symptoms (nausea, flatulence, bloating and abdominal pain).

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2014
Registry last updated
Sep 23, 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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