NCT02075788

Brief Summary

The purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

8 months

First QC Date

February 26, 2014

Last Update Submit

January 21, 2016

Conditions

HyperglycemiaLack of Satiety

Outcome Measures

Primary Outcomes (1)

  • Determination of glycemic index based on collection of capillary plasma glucose

    Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes

Secondary Outcomes (1)

  • Self reported ratings of satiety

    Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours

Study Arms (3)

Commercial white bread

PLACEBO COMPARATOR

All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.

Other: Commercial white bread

Millet based products (porridge etc.)

EXPERIMENTAL

All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.

Other: Millet based products (porridge etc.)

Corn based products (porridge etc.)

ACTIVE COMPARATOR

All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.

Other: Corn based products (porridge etc.)

Interventions

Commercial white breadOTHER
Commercial white bread
Corn based products (porridge etc.)OTHER
Corn based products (porridge etc.)
Millet based products (porridge etc.)OTHER
Millet based products (porridge etc.)

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men, age 19-40, non-smoking
  • Normal fasting plasma glucose (\<5.6 mmol/L but not below 3.6 mmol/L)
  • Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. \<7.8 mmol/L but not below 3.6 mmol/L)
  • BMI ranging from 18.5 to 29.9 kg/m2

You may not qualify if:

  • Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
  • Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
  • Smoking or use of recreational drugs
  • Heavy alcohol use (defined as typically \>14 drinks per week or \>4 drinks on one occasion)
  • Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
  • Restrained eater as defined by the questionnaire at screening (Three Factor Eating Questionnaire, Stunkard et al.,1985)
  • Food neophobic defined by Food Neophobia Scale questionnaire
  • Unusual sleep patterns or irregular breakfast consumption
  • Recent (i.e. \>4 kg in previous 3 months) or intended weight loss or gain
  • Food allergies or any life-threatening allergy (food or otherwise)
  • Inflammatory bowel disease or other gastrointestinal disorders
  • Use of drugs which influence carbohydrate metabolism
  • Training or elite athletes
  • Inability to adhere to Study Protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 3, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

June 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

CA(1)