NCT02506972

Brief Summary

The purpose of this study was to determine the impact of serving size and the addition of sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice cereal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable diabetes-mellitus

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, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 21, 2015

Last Update Submit

July 22, 2015

Conditions

Keywords

Blood glucoseHumansPostprandialSugarCarbohydrateOat beta-glucan

Outcome Measures

Primary Outcomes (1)

  • Incremental area under the blood glucose response curve

    For 2 hours after consuming each test meal

Secondary Outcomes (5)

  • Peak rise of blood glucose

    During 2 hour period after consuming each test meal

  • Time to peak

    During 2 hour period after consuming each test meal

  • Mean rate of decline in blood glucose

    During 2 hour period after consuming each test meal

  • Maximum rate of decline in blood glucose

    During 2 hour period after consuming each test meal

  • Time to baseline

    During 2 hour period after consuming each test meal

Study Arms (8)

30g oats

OTHER

Classic Quick Quaker Oats

Other: Classic Quaker Quick Oats

30g oats plus 9g sugar

OTHER

Classic Quick Quaker Oats

Other: Classic Quaker Quick Oats

40g oats

OTHER

Classic Quick Quaker Oats

Other: Classic Quaker Quick Oats

60g oats

OTHER

Classic Quick Quaker Oats

Other: Classic Quaker Quick Oats

22g cream of rice cereal

OTHER

Cream of Rice Cereal, B\&G Foods, Inc.

Other: Cream of Rice Cereal

29g cream of rice cereal

OTHER

Cream of Rice Cereal, B\&G Foods, Inc.

Other: Cream of Rice Cereal

33g cream of rice cereal

OTHER

Cream of Rice Cereal, B\&G Foods, Inc.

Other: Cream of Rice Cereal

44g cream of rice cereal

OTHER

Cream of Rice Cereal, B\&G Foods, Inc.

Other: Cream of Rice Cereal

Interventions

Various doses of oats without or with sugar

30g oats30g oats plus 9g sugar40g oats60g oats

Various doses of cereal without sugar

22g cream of rice cereal29g cream of rice cereal33g cream of rice cereal44g cream of rice cereal

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index (BMI) 20.0 - 34.9 kg/m²

You may not qualify if:

  • known to have diabetes
  • use of medications considered by the principal investigator to influence glycemic responses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

  • Wolever TMS, van Klinken BJ, Spruill SE, Jenkins AL, Chu Y, Harkness L. Effect of serving size and addition of sugar on the glycemic response elicited by oatmeal: A randomized, cross-over study. Clin Nutr ESPEN. 2016 Dec;16:48-54. doi: 10.1016/j.clnesp.2016.07.003. Epub 2016 Sep 1.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas MS Wolever, MD, PhD

    Glycemic Index Laboratories, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 23, 2015

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations