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

Not Applicable

Completed

• Conditions: Diabetes Type 2
• Interventions: Dietary Supplement: onyx sorghum; Dietary Supplement: whole wheat flour

• Registration Number: NCT03714451
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2018-11-01
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onyx Group	onyx sorghum	Patients with T2DM will receive food products containing onyx sorghum (Onyx Group).
Wheat Flour Group	whole wheat flour	Patients with T2DM will receive food products with wheat flour.

Primary Outcome Measures

Name	Time	Method
Change in glycemic variability	day 28	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

Name	Time	Method
Changes in BMI	day 28	change in BMI from baseline
Changes in weight	day 28	change in weight from baseline
Change in glucose levels	day 28	change in blood glucose levels

Trial Locations

Locations (3)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Yale Center for Clinical Investigation; 🇺🇸 New Haven, Connecticut, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States