Clinical trial NCT02923089: Postprandial Blood Glucose and Insulin Levels Following Consumption of Lentil-containing Food Products
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glycemia in Healthy Adults
Keywords: Diabetes
Lentils
Pulses
Postprandial glycemia
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2016-10-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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).

Eligibility 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

Primary outcomes:
measure: Postprandial blood glucose
timeFrame: 2 hours postprandial
measure: Postprandial plasma insulin
timeFrame: 2 hours postprandial
Secondary outcomes:
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit
state: Ontario
Study officials:
affiliation: University of Guelph
name: Alison M Duncan, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: