NCT03128684

Brief Summary

The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils within food products (muffins and chilies) on satiety and food intake in healthy adults.

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 May 2017

Shorter than P25 for not_applicable

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

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

April 20, 2017

Last Update Submit

December 15, 2018

Conditions

AppetiteSatietyFood Intake

Keywords

lentilssatietyappetitefood intake24-hour energy intake

Outcome Measures

Primary Outcomes (2)

  • Satiety

    Satiety will be measured using 100mm visual analog scales (VAS) rating appetite sensations of hunger, fullness, desire to eat, and prospective consumption

    Acute: 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after treatment consumption

  • Food Intake

    Food intake will be measured as kilocalories using an ad libitum cheese pizza test meal

    Acute: 180 minutes following consumption of treatment

Secondary Outcomes (1)

  • 24-hour Energy Intake

    Acute: 24 hours

Study Arms (6)

Small Green Lentil Muffin

EXPERIMENTAL
Other: Small Green Lentil Muffin

Split Red Lentil Muffin

EXPERIMENTAL
Other: Split Red Lentil Muffin

Wheat Muffin

PLACEBO COMPARATOR
Other: Wheat Muffin

Small Green Lentil Chili

EXPERIMENTAL
Other: Small Green Lentil Chili

Split Red Lentil Chili

EXPERIMENTAL
Other: Split Red Lentil Chili

Rice Chili

PLACEBO COMPARATOR
Other: Rice Chili

Interventions

Small Green Lentil MuffinOTHER

Consumption of small green lentil muffin; consumption of ad libitum pizza test meal after 180 minutes

Small Green Lentil Muffin
Split Red Lentil MuffinOTHER

Consumption of split red lentil muffin; consumption of ad libitum pizza test meal after 180 minutes

Split Red Lentil Muffin
Wheat MuffinOTHER

Consumption of wheat muffin; consumption of ad libitum pizza test meal after 180 minutes

Wheat Muffin
Small Green Lentil ChiliOTHER

Consumption of small green lentil chili; consumption of ad libitum pizza test meal after 180 minutes

Small Green Lentil Chili
Split Red Lentil ChiliOTHER

Consumption of split red lentil chili; consumption of ad libitum pizza test meal after 180 minutes

Split Red Lentil Chili
Rice ChiliOTHER

Consumption of rice chili; consumption of ad libitum pizza test meal after 180 minutes

Rice Chili

Eligibility Criteria

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

You may qualify if:

  • Healthy males and females
  • Age 18 to 40 years old
  • BMI 20-30 kg/m2

You may not qualify if:

  • Blood pressure greater than 140/90 mmHg
  • Major medical condition including a history of AIDS or hepatitis
  • Medical or surgical event requiring hospitalization within 3 months of randomization
  • Any medication use except stable dose (3 months) of oral contraceptives, blood pressure or statin medications
  • Tobacco use
  • Probiotic supplement use
  • Dietary fibre supplement use
  • Natural health products (NHPs) used for glycemic control (all other NHPs are ok, as long as stable for 3 months)
  • Pulse consumption greater than 4 servings per week
  • Food allergy or non-food life threatening allergy
  • Pregnant or breastfeeding
  • Alcohol consumption of greater than 14 drinks per week or greater than 4 drinks per sitting
  • Recent or intended significant weight loss or gain (greater than 4kg in previous 3 months)
  • Elite athletes
  • Shift workers
  • +3 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)

  • Clark SL, Ramdath DD, King BV, O'Connor KE, Aliani M, Hawke A, Duncan AM. Food Type and Lentil Variety Affect Satiety Responses but Not Food Intake in Healthy Adults When Lentils Are Substituted for Commonly Consumed Carbohydrates. J Nutr. 2019 Jul 1;149(7):1180-1188. doi: 10.1093/jn/nxz050.

    PMID: 31152672DERIVED

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

April 20, 2017

First Posted

April 25, 2017

Study Start

May 1, 2017

Primary Completion

February 8, 2018

Study Completion

February 9, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)