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Completed

NCT Number: NCT02923089

Postprandial Blood Glucose and Insulin Levels Following Consumption of Lentil-containing Food Products

This study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. Blood samples will be obtained by finger prick before and for 2 hours after the meal and analyzed for glucose and insulin.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

About this study

The purpose of the current study is to determine the effects of lentil-containing food products on postprandial blood glucose and insulin levels in healthy premenopausal women and men aged 18-40 years old.This study will use a randomized crossover design. Participants will complete a series of 9 study visits during which participants will consume 9 study treatment meals consisting of muffins, soup and chilli, with and without lentils. Participants will then have their blood sampled for the following 2 hours by finger prick. Participants will remain seated during the test period. All study visits will occur at the Human Nutraceutical Research Unit and be separated by a washout period of 3-7 days. Throughout the study, it will be asked that participants' lifestyle and physical activity remain unchanged. Participants will be instructed to not start any new dietary approaches, and to not start any new natural health products (unless instructed by a physician).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women
  • Age 18-40 years (aiming for equal distribution among 18-29, 30-40 years of age)
  • BMI 20-30 kg/m2

Exclusion criteria

  • Diabetes (fasting blood glucose ≥7.0 mmol/L and/or 2hr blood glucose >11.1 mmol/L post-75g OGTT) 1
  • Impaired Glucose Tolerance (IGT) (Fasting blood glucose 6.1-6.9 mmol/L and/or 2hr blood glucose 7.8-11.0 mmol/L post-75g OGTT) 1
  • Blood pressure >140/90 mm Hg
  • Any major medical condition including a history of AIDS or hepatitis
  • Medical or surgical event requiring hospitalization within 3 months of randomization
  • Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications
  • Natural health products (NHPs) used for glycemic control (all other NHPs okay as long as table for 3 months)
  • Tobacco use
  • Probiotic supplement use
  • Dietary fibre supplement use
  • Pulse consumption >4 servings per week
  • Food allergy or non-food life threatening allergy
  • Alcohol consumption >14 drinks/week or >4 drinks/sitting
  • Recent or intended significant weight loss or gain (>4 kg in previous 3 months)
  • Elite athletes
  • Shift workers

Treatment and study plan

Muffin: 25g available carbohydrate from small green lentil

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Muffin: 25g available carbohydrate from split red lentil

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Wheat Muffin

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Soup: 25g available carbohydrate from small green lentil

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Soup: 25g available carbohydrate from split red lentil

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Potato soup

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Chili: 25g available carbohydrate from small green lentil

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Chili: 25g available carbohydrate from split red lentil

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Rice Chili

Other

Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Primary outcomes

  1. Postprandial blood glucose

    Time frame: 2 hours postprandial

  2. Postprandial plasma insulin

    Time frame: 2 hours postprandial

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Agriculture and Agri-Food Canada

Registry information

Official study title

The Love of Lentils (LoL) Study - Phase 2: The Effect of Acute Consumption of Lentil-containing Food Products on Post-prandial Blood Glucose and Insulin in Healthy Adults

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2016
Registry last updated
Apr 3, 2018

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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