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

Postprandial Glycemia in Healthy Adults Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923089
• Other study ID #: 16AU008
• Status: Completed
• Phase: N/A
• First received: September 25, 2016
• Last updated: March 30, 2018
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Postprandial Glycemia in Healthy Adults

Intervention

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.
• Muffin: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
• Wheat muffin
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
• Soup: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
• Soup: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
• Potato soup
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
• Chili: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
• Chili: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
• Rice chili
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Guelph	Agriculture and Agri-Food Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood glucose		2 hours postprandial
Primary	Postprandial plasma insulin		2 hours postprandial