NCT03223935

Brief Summary

An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

August 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
Last Updated

January 23, 2023

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

July 6, 2017

Last Update Submit

January 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Food intake

    Ab libitum meal

    At 60 min

Secondary Outcomes (6)

  • Subjective appetite

    0-200 min

  • Blood glucose concentrations

    0-200 min

  • Physical comfort

    0-200 min

  • Energy and fatigue

    0-200 min

  • Palatability of meal

    At 60 min

  • +1 more secondary outcomes

Study Arms (6)

Roasted snacks

ACTIVE COMPARATOR

Corn nuts

Other: Corn nuts

Roasted chickpeas

EXPERIMENTAL

Chickpeas

Other: Chickpeas

Roasted yellow peas

EXPERIMENTAL

Yellow peas

Other: Yellow peas

Roasted pinto beans

EXPERIMENTAL

Pinto beans

Other: Pinto beans

Roasted soybeans

EXPERIMENTAL

Soybeans

Other: Soybeans

Roasted almonds

EXPERIMENTAL

Almonds

Other: Almonds

Interventions

Roasted corn nut snack

Roasted snacks

Roasted chickpea snack

Roasted chickpeas

Roasted yellow pea snack

Roasted yellow peas

Roasted pinto bean snack

Roasted pinto beans

Roasted soybean snack

Roasted soybeans
AlmondsOTHER

Roasted almond snack

Roasted almonds

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: ≥18.5 and ≤29.9 kg/m2
  • Fasting serum glucose: ≤5.5 mmol/L

You may not qualify if:

  • Fasting serum glucose \> 5.5 mmol/L
  • Smoking
  • Thyroid problems
  • Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
  • Presence of a gastrointestinal disorder or surgeries within the past year
  • Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment
  • Known to be pregnant or lactating
  • Known intolerance, sensitivity or allergy to any ingredients in the study products.
  • Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
  • Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
  • Weight gain or loss of at least 10lbs in previous three months
  • Excessive alcohol intake
  • Restrained Eaters (identified by Eating Habits Questionnaire)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter JH Jones, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized, controlled cross-over acute trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 21, 2017

Study Start

August 11, 2017

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

January 23, 2023

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Individual participant data requests should be submitted to the PI.

Locations