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

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ClinicalTrials.gov Identifier: NCT02923089
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Alison Duncan, University of Guelph

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postprandial Glycemia in Healthy Adults Other: Muffin: 25g available carbohydrate from small green lentil Other: Muffin: 25g available carbohydrate from split red lentil Other: Wheat muffin Other: Soup: 25g available carbohydrate from small green lentil Other: Soup: 25g available carbohydrate from split red lentil Other: Potato soup Other: Chili: 25g available carbohydrate from small green lentil Other: Chili: 25g available carbohydrate from split red lentil Other: Rice chili Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : January 2017
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Small Green Lentil Muffin
Muffin: 25g available carbohydrate from small green lentil
Other: Muffin: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Experimental: Split Red Lentil Muffin
Muffin: 25g available carbohydrate from split red lentil
Other: Muffin: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Placebo Comparator: Wheat Muffin
Muffin: 25g available carbohydrate from wheat
Other: Wheat muffin
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Experimental: Small Green Lentil Soup
Soup: 25g available carbohydrate from small green lentil
Other: Soup: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Experimental: Split Red Lentil Soup
Soup: 25g available carbohydrate from split red lentil
Other: Soup: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Placebo Comparator: Potato Soup
Soup: 25g available carbohydrate from potato
Other: Potato soup
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Experimental: Small Green Lentil Chili
Chili: 25g available carbohydrate from small green lentil
Other: Chili: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Experimental: Split Red Lentil Chili
Chili: 25g available carbohydrate from split red lentil
Other: Chili: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Placebo Comparator: Rice Chili
Chili: 25g available carbohydrate from rice
Other: Rice chili
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.




Primary Outcome Measures :
  1. Postprandial blood glucose [ Time Frame: 2 hours postprandial ]
  2. Postprandial plasma insulin [ Time Frame: 2 hours postprandial ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02923089


Locations
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Canada, Ontario
Human Nutraceutical Research Unit
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
Agriculture and Agri-Food Canada
Investigators
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Principal Investigator: Alison M Duncan, PhD, RD University of Guelph

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Responsible Party: Alison Duncan, Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT02923089    
Other Study ID Numbers: 16AU008
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alison Duncan, University of Guelph:
Diabetes
Lentils
Pulses
Postprandial glycemia
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs