NCT03387345

Brief Summary

The purpose of this research was to investigate 5 different formulations of whole grain barley and refined white rice against a control of white bread on post-prandial glycemic response, as well as self-reported hunger/satiety in a randomized cross-over trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

Study Start

First participant enrolled

February 13, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

December 19, 2017

Last Update Submit

December 28, 2017

Conditions

Keywords

glucosedietary fiberglycemiawhole grain

Outcome Measures

Primary Outcomes (1)

  • Post-prandial glycemia

    Incremental area under the curve(iAUC) for plasma glucose concentrations were measured at 0, 15, 30, 45, 60, 90 and 120 min using the trapezoidal method to evaluate the glycemic response to each grain treatment.

    0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min

Secondary Outcomes (4)

  • Self-reported hunger

    0 min, 15 min, 30 min, 60 min, 90 min, 120 min

  • Self-reported satiety

    0 min, 15 min, 30 min, 60 min, 90 min, 120 min

  • Self-reported fullness

    0 min, 15 min, 30 min, 60 min, 90 min, 120 min

  • Self-reported prospective food consumption

    0 min, 15 min, 30 min, 60 min, 90 min, 120 min

Study Arms (6)

bread-50/50-steelcut-80/20-flake-rice

EXPERIMENTAL

25 g of available carbohydrate was delivered to participants via (1) white bread, followed by (2) 50/50 rice-barley mix, followed by (3) 100% steel cut barley, followed by (4) 80/20 rice-barley mix, followed by (5) 100% barley flakes, followed by (6) 100% rice

Other: 100% steel cut barleyOther: 100% barley flakesOther: 50/50 rice-barley mixOther: 80/20 rice-barley mixOther: 100% riceOther: white bread

50/50-steelcut-80/20-flake-rice-bread

EXPERIMENTAL

25 g of available carbohydrate was delivered to participants via (1) 50/50 rice-barley mix, followed by (2) 100% steel cut barley, followed by (3) 80/20 rice-barley mix, followed by (4) 100% barley flakes, followed by (5) 100% rice, followed by (6) white bread

Other: 100% steel cut barleyOther: 100% barley flakesOther: 50/50 rice-barley mixOther: 80/20 rice-barley mixOther: 100% riceOther: white bread

steelcut-80/20-flake-rice-bread-50/50

EXPERIMENTAL

25 g of available carbohydrate was delivered to participants via (1) 100% steel cut barley, followed by (2) 80/20 rice-barley mix, followed by (3) 100% barley flakes, followed by (4) 100% rice, followed by (5) white bread, followed by (6) 50/50 rice-barley mix

Other: 100% steel cut barleyOther: 100% barley flakesOther: 50/50 rice-barley mixOther: 80/20 rice-barley mixOther: 100% riceOther: white bread

80/20-flake-rice-bread-50/50-steelcut

EXPERIMENTAL

25 g of available carbohydrate was delivered to participants via (1) 80/20 rice-barley mix, followed by (2) 100% barley flakes, followed by (3) 100% rice, followed by (4) white bread, followed by (5) 50/50 rice-barley mix, followed by (6) 100% steel cut barley

Other: 100% steel cut barleyOther: 100% barley flakesOther: 50/50 rice-barley mixOther: 80/20 rice-barley mixOther: 100% riceOther: white bread

flake-rice-bread-50/50-steelcut-80/20

EXPERIMENTAL

25 g of available carbohydrate was delivered to participants via (1) 100% barley flakes, followed by (2) 100% rice, followed by (3) white bread, followed by (4) 50/50 rice-barley mix, followed by (5) 100% steel cut barley, followed by (6) 80/20 rice-barley mix

Other: 100% steel cut barleyOther: 100% barley flakesOther: 50/50 rice-barley mixOther: 80/20 rice-barley mixOther: 100% riceOther: white bread

rice-bread-50/50-steelcut-80/20-flake

EXPERIMENTAL

25 g of available carbohydrate was delivered to participants via (1) 100% rice, followed by (2) white bread, followed by (3) 50/50 rice-barley mix, followed by (4) 100% steel cut barley, followed by (5) 80/20 rice-barley mix, followed by (6) 100% barley flakes

Other: 100% steel cut barleyOther: 100% barley flakesOther: 50/50 rice-barley mixOther: 80/20 rice-barley mixOther: 100% riceOther: white bread

Interventions

25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).

50/50-steelcut-80/20-flake-rice-bread80/20-flake-rice-bread-50/50-steelcutbread-50/50-steelcut-80/20-flake-riceflake-rice-bread-50/50-steelcut-80/20rice-bread-50/50-steelcut-80/20-flakesteelcut-80/20-flake-rice-bread-50/50

25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).

50/50-steelcut-80/20-flake-rice-bread80/20-flake-rice-bread-50/50-steelcutbread-50/50-steelcut-80/20-flake-riceflake-rice-bread-50/50-steelcut-80/20rice-bread-50/50-steelcut-80/20-flakesteelcut-80/20-flake-rice-bread-50/50

25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).

50/50-steelcut-80/20-flake-rice-bread80/20-flake-rice-bread-50/50-steelcutbread-50/50-steelcut-80/20-flake-riceflake-rice-bread-50/50-steelcut-80/20rice-bread-50/50-steelcut-80/20-flakesteelcut-80/20-flake-rice-bread-50/50

25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).

50/50-steelcut-80/20-flake-rice-bread80/20-flake-rice-bread-50/50-steelcutbread-50/50-steelcut-80/20-flake-riceflake-rice-bread-50/50-steelcut-80/20rice-bread-50/50-steelcut-80/20-flakesteelcut-80/20-flake-rice-bread-50/50

25 g of available carbohydrate was delivered to participants via Goya medium grain white rice

50/50-steelcut-80/20-flake-rice-bread80/20-flake-rice-bread-50/50-steelcutbread-50/50-steelcut-80/20-flake-riceflake-rice-bread-50/50-steelcut-80/20rice-bread-50/50-steelcut-80/20-flakesteelcut-80/20-flake-rice-bread-50/50

25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)

50/50-steelcut-80/20-flake-rice-bread80/20-flake-rice-bread-50/50-steelcutbread-50/50-steelcut-80/20-flake-riceflake-rice-bread-50/50-steelcut-80/20rice-bread-50/50-steelcut-80/20-flakesteelcut-80/20-flake-rice-bread-50/50

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, English speaking adults;
  • BMI between 18 and 30 kg/m2

You may not qualify if:

  • History of GI malabsorption diseases, food allergy or intolerance to gluten;
  • Prediabetes, and/or diabetes, and/or treatment with diabetic medications for any reason;
  • Hypertension, hypothyroidism and other chronic disease that affects nutrient metabolism;
  • Any women pregnant or lactating, or expecting to become pregnant during the study;
  • Individuals with a history of bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Study Officials

  • Corrie M Whisner, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Otherwise healthy male and female adults
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 2, 2018

Study Start

February 13, 2017

Primary Completion

September 4, 2017

Study Completion

September 18, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations