NCT02923089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

September 25, 2016

Last Update Submit

March 30, 2018

Conditions

Keywords

DiabetesLentilsPulsesPostprandial glycemia

Outcome Measures

Primary Outcomes (2)

  • Postprandial blood glucose

    2 hours postprandial

  • Postprandial plasma insulin

    2 hours postprandial

Study Arms (9)

Small Green Lentil Muffin

EXPERIMENTAL

Muffin: 25g available carbohydrate from small green lentil

Other: Muffin: 25g available carbohydrate from small green lentil

Split Red Lentil Muffin

EXPERIMENTAL

Muffin: 25g available carbohydrate from split red lentil

Other: Muffin: 25g available carbohydrate from split red lentil

Wheat Muffin

PLACEBO COMPARATOR

Muffin: 25g available carbohydrate from wheat

Other: Wheat muffin

Small Green Lentil Soup

EXPERIMENTAL

Soup: 25g available carbohydrate from small green lentil

Other: Soup: 25g available carbohydrate from small green lentil

Split Red Lentil Soup

EXPERIMENTAL

Soup: 25g available carbohydrate from split red lentil

Other: Soup: 25g available carbohydrate from split red lentil

Potato Soup

PLACEBO COMPARATOR

Soup: 25g available carbohydrate from potato

Other: Potato soup

Small Green Lentil Chili

EXPERIMENTAL

Chili: 25g available carbohydrate from small green lentil

Other: Chili: 25g available carbohydrate from small green lentil

Split Red Lentil Chili

EXPERIMENTAL

Chili: 25g available carbohydrate from split red lentil

Other: Chili: 25g available carbohydrate from split red lentil

Rice Chili

PLACEBO COMPARATOR

Chili: 25g available carbohydrate from rice

Other: Rice chili

Interventions

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

Small Green Lentil Muffin

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

Split Red Lentil Muffin

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.

Small Green Lentil Soup

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

Split Red Lentil Soup

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.

Small Green Lentil Chili

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

Split Red Lentil Chili

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

Rice Chili

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alison M Duncan, PhD, RD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2016

First Posted

October 4, 2016

Study Start

January 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations