NCT02940158

Brief Summary

The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable healthy

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
6 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

September 25, 2016

Last Update Submit

May 2, 2018

Conditions

Healthy

Keywords

lentilsdiabetesglycemiainsulinglucose

Outcome Measures

Primary Outcomes (2)

  • Postprandial Blood Glucose

    2 hours Postprandial

  • Postprandial Blood Insulin

    2 hours postprandial

Study Arms (2)

1/2 cup

OTHER

1/2 cup serving size arm

Other: 1/2 cup- small red lentilOther: 1/2 cup- small green lentilOther: 1/2 cup- cornOther: 1/2 cup- macaroniOther: 1/2 cup- white potatoOther: 1/2 cup- white rice

1/4 cup

OTHER

1/4 cup serving size arm

Other: 1/4 cup- Small red lentilOther: 1/4 cup- Small green lentilOther: 1/4 cup- cornOther: 1/4 cup- macaroniOther: 1/4 cup- white potatoOther: 1/4 cup- white rice

Interventions

1/4 cup- Small red lentilOTHER
1/4 cup
1/4 cup- Small green lentilOTHER
1/4 cup
1/4 cup- cornOTHER
1/4 cup
1/4 cup- macaroniOTHER
1/4 cup
1/4 cup- white potatoOTHER
1/4 cup
1/4 cup- white riceOTHER
1/4 cup
1/2 cup- small red lentilOTHER
1/2 cup
1/2 cup- small green lentilOTHER
1/2 cup
1/2 cup- cornOTHER
1/2 cup
1/2 cup- macaroniOTHER
1/2 cup
1/2 cup- white potatoOTHER
1/2 cup
1/2 cup- white riceOTHER
1/2 cup

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
  • Body mass index (BMI) 20-30 kg/m2

You may not qualify if:

  • Tobacco use
  • Pregnant or breastfeeding
  • Fasting blood glucose ≥ 7.0 mmol/L
  • Two hour blood glucose ≥ 11.1 mmol/L after consuming 75g glucose drink (Oral Glucose Tolerance Test beverage)
  • 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
  • Blood pressure \>140/90 mm Hg
  • Natural health products (NHPs) used for glycemic control
  • Probiotic supplements
  • Dietary fibre supplements
  • Consumption of \>4 servings of pulses per week
  • Food allergy or non-food life threatening allergy
  • Shift workers
  • Alcohol consumption \>14 drinks/week or \>4 drinks/sitting
  • +2 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 MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

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 20, 2016

Study Start

October 1, 2016

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)