NCT04377282

Brief Summary

A diet rich in whole grains has been linked to multiple beneficial health outcomes, including cardiovascular health, weight loss and a decreased risk of acquiring type 2 diabetes. However, grain products vary due to their botanical origin, composition, and post-harvest processing. While wheat is considered a dominant grain crop in Canada, the minor crops, including gluten-free buckwheat, become popular alternatives to wheat products such as couscous. Both buckwheat groats and couscous are traditionally consumed in the form of the porridge or side dish, however, their acute effects on satiety and food intake remain unknown. The objective of this study is to investigate the short-term effects of couscous and buckwheat on satiety and short-term food intake in young adult males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 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

Study Start

First participant enrolled

March 1, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

8 years

First QC Date

May 2, 2020

Last Update Submit

August 31, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Food intake

    The amount of energy (kcal) consumed ad libitum with the test meal (pizza lunch) two hours later.

    120 minutes

  • Subjective appetite

    The subjective assessment of appetite parameters including a desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).

    0-120 minutes

Secondary Outcomes (2)

  • Subjective feeling of physical comfort

    0-120 minutes

  • Subjective perception of food palatability (pleasantness)

    0, 120 minutes

Study Arms (3)

Buckwheat

EXPERIMENTAL

Cooked buckwheat

Other: Food-1

Couscous

EXPERIMENTAL

Cooked couscous

Other: Food-2

Water

EXPERIMENTAL

Potable water

Other: Food-3

Interventions

Food-1OTHER

Cooked buckwheat

Buckwheat
Food-2OTHER

Cooked couscous

Couscous
Food-3OTHER

Water

Water

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • years

You may not qualify if:

  • Smokers
  • Taking medication
  • Breakfast skippers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

Study Officials

  • Bohdan L. L Luhovyy, PhD

    Mount Saint Vincent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 6, 2020

Study Start

March 1, 2012

Primary Completion

March 15, 2020

Study Completion

June 26, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations