NCT02426606

Brief Summary

The purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.

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 Nov 2014

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

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

April 16, 2015

Last Update Submit

October 24, 2016

Conditions

Healthy

Keywords

LentilsPost-prandialGlycemic responseInsulin responseDiabetesMixed mealGlycemiaSlowly digestible starchPost-prandial glycemia

Outcome Measures

Primary Outcomes (2)

  • Postprandial blood glucose

    Different meals will be consumed on separate occasions over 3-6 week period.

    Acute- 2 hours following meal

  • Postprandial blood insulin

    Different meals will be consumed on separate occasions over 3-6 week period.

    Acute- 2 hours following meal

Study Arms (9)

White bread

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Lentil 1 + white rice

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Lentil 2 + white rice

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Lentil 3 + white rice

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

White rice

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Lentil 1 + potato

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Lentil 2 + potato

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Lentil 3 + potato

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Potato

EXPERIMENTAL
Other: Various lentil varieties (varying in slow digested starch content)

Interventions

Various lentil varieties (varying in slow digested starch content)OTHER

Randomized, cross-over block design. Comparison of glycemic and insulinemic responses following meals composed of: * white rice or white rice combined with 1 of 3 different lentil varieties or * white potato or white potato combined with 1 of 3 different lentil varieties Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC. Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).

Lentil 1 + potatoLentil 1 + white riceLentil 2 + potatoLentil 2 + white riceLentil 3 + potatoLentil 3 + white ricePotatoWhite breadWhite rice

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
  • BMI 20-30 kg/m2

You may not qualify if:

  • Tobacco use
  • Pregnant or breastfeeding
  • Fasting blood glucose ≥ 7.0 mmol/L
  • 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
  • Recent or intended significant weight loss or gain (\>4 kg in previous 3 months)
  • +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

Related Publications (1)

  • Moravek D, Duncan AM, VanderSluis LB, Turkstra SJ, Rogers EJ, Wilson JM, Hawke A, Ramdath DD. Carbohydrate Replacement of Rice or Potato with Lentils Reduces the Postprandial Glycemic Response in Healthy Adults in an Acute, Randomized, Crossover Trial. J Nutr. 2018 Apr 1;148(4):535-541. doi: 10.1093/jn/nxy018.

    PMID: 29659967DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alison M Duncan, Ph.D, R.D

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 27, 2015

Study Start

November 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)