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Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
onyx sorghum
whole wheat flour
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Type 2

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages 30-65 years
  • A1c < 8.5%
  • BMI > 18.5

Exclusion Criteria:

  • known malignancy, anemia, kidney disease, and/or liver disease
  • untreated thyroid disease
  • uncontrolled hypertension
  • initiation of any anti-diabetes medications within the last 3 months
  • greater than 5% change in weight in the last 3 months
  • current or recent steroid use in the last 3 months
  • for women: pregnancy or breastfeeding

Sites / Locations

  • Yale New Haven Hospital
  • Yale University School of Medicine
  • Yale Center for Clinical Investigation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Onyx Group

Wheat Flour Group

Arm Description

Patients with T2DM will receive food products containing onyx sorghum (Onyx Group).

Patients with T2DM will receive food products with wheat flour.

Outcomes

Primary Outcome Measures

Change in glycemic variability
The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.
Change in glycemic variability
The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.
Change in glycemic variability
The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.

Secondary Outcome Measures

Changes in weight
change in weight from baseline
Changes in weight
change in weight from baseline
Changes in weight
change in weight from baseline
Changes in BMI
change in BMI from baseline
Changes in BMI
change in BMI from baseline
Changes in BMI
change in BMI from baseline
Changes in BMI
change in BMI from baseline
Change in glucose levels
change in blood glucose levels
Change in glucose levels
change in blood glucose levels
Change in glucose levels
change in blood glucose levels
Change in glucose levels
change in blood glucose levels

Full Information

First Posted
October 18, 2018
Last Updated
February 10, 2023
Sponsor
Yale University
Collaborators
Silver Palate Kitchens Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03714451
Brief Title
Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
Official Title
Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Silver Palate Kitchens Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).
Detailed Description
The plan is to study 24 participants with T2DM, who are otherwise healthy. The study will be double-blinded and randomized. Participants will first attend a screening visit (Visit #1) to determine eligibility. Then, eligible participants will be asked to wear a FreeStyle Libre Pro continuous glucose monitor (CGM) for up to 14 days (Visit #2). After this 14-day CGM session, participants will be randomly assigned (1:1) to one of two groups that will receive: 1) food products containing onyx sorghum (Onyx Group) or 2) food products with wheat flour (Control Group). The diet intervention will last a total of 28 days. Participants will have weekly visits to pick up food and bi-weekly blood draws (no more than 20mL at each visit). They will also be asked to wear the CGM throughout the diet intervention and will record their food intake in a daily food diary to confirm that the diet intervention is being followed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blinded randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Onyx Group
Arm Type
Experimental
Arm Description
Patients with T2DM will receive food products containing onyx sorghum (Onyx Group).
Arm Title
Wheat Flour Group
Arm Type
Active Comparator
Arm Description
Patients with T2DM will receive food products with wheat flour.
Intervention Type
Dietary Supplement
Intervention Name(s)
onyx sorghum
Intervention Description
The diet intervention will last a total of 28 days. Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat. In the Onyx Group, 25% of carbohydrate will come from the onyx sorghum, and at least three foods per day (including cereals, bread, muffins, pasta, and smoothie boosters) will contain this.
Intervention Type
Dietary Supplement
Intervention Name(s)
whole wheat flour
Intervention Description
Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat.
Primary Outcome Measure Information:
Title
Change in glycemic variability
Description
The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.
Time Frame
day 1
Title
Change in glycemic variability
Description
The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.
Time Frame
14 days
Title
Change in glycemic variability
Description
The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Changes in weight
Description
change in weight from baseline
Time Frame
day 1
Title
Changes in weight
Description
change in weight from baseline
Time Frame
day 14
Title
Changes in weight
Description
change in weight from baseline
Time Frame
day 28
Title
Changes in BMI
Description
change in BMI from baseline
Time Frame
upon screening
Title
Changes in BMI
Description
change in BMI from baseline
Time Frame
day 1
Title
Changes in BMI
Description
change in BMI from baseline
Time Frame
day 14
Title
Changes in BMI
Description
change in BMI from baseline
Time Frame
day 28
Title
Change in glucose levels
Description
change in blood glucose levels
Time Frame
upon enrollment
Title
Change in glucose levels
Description
change in blood glucose levels
Time Frame
day 1
Title
Change in glucose levels
Description
change in blood glucose levels
Time Frame
day 14
Title
Change in glucose levels
Description
change in blood glucose levels
Time Frame
day 28
Other Pre-specified Outcome Measures:
Title
Eating behavior
Description
measure of food provided and returned
Time Frame
day 1
Title
Eating behavior
Description
measure of food provided and returned
Time Frame
day 14
Title
Eating behavior
Description
measure of food provided and returned
Time Frame
day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 30-65 years A1c < 8.5% BMI > 18.5 Exclusion Criteria: known malignancy, anemia, kidney disease, and/or liver disease untreated thyroid disease uncontrolled hypertension initiation of any anti-diabetes medications within the last 3 months greater than 5% change in weight in the last 3 months current or recent steroid use in the last 3 months for women: pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Belfort de Aguiar, MD, PhD
Organizational Affiliation
Yale School of Medicine Department of Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale Center for Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes

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