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

To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2
• Intervention / Treatment: Dietary supplement: onyx sorghum; Dietary supplement: whole wheat flour

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renata Belfort De Aguiar, MD, PhD; Phone Number: 203-785-7474; Email: renata.aguiar@yale.edu
• Study Contact Backup: Name: Jessica Leventhal, DNP, APRN; Phone Number: 475-331-8966; Email: jessica.leventhal@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine
    • New Haven, Connecticut, United States, 06519
      • Yale Center for Clinical Investigation
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Onyx Group; Patients with T2DM will receive food products containing onyx sorghum (Onyx Group).	Dietary supplement: onyx sorghum; 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.
ACTIVE_COMPARATOR: Wheat Flour Group; Patients with T2DM will receive food products with wheat flour.	Dietary supplement: whole wheat flour; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1
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.	14 days
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.	day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight	change in weight from baseline	day 1
Changes in weight	change in weight from baseline	day 14
Changes in weight	change in weight from baseline	day 28
Changes in BMI	change in BMI from baseline	upon screening
Changes in BMI	change in BMI from baseline	day 1
Changes in BMI	change in BMI from baseline	day 14
Changes in BMI	change in BMI from baseline	day 28
Change in glucose levels	change in blood glucose levels	upon enrollment
Change in glucose levels	change in blood glucose levels	day 1
Change in glucose levels	change in blood glucose levels	day 14
Change in glucose levels	change in blood glucose levels	day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating behavior	measure of food provided and returned	day 1
Eating behavior	measure of food provided and returned	day 14
Eating behavior	measure of food provided and returned	day 28

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Silver Palate Kitchens Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): December 20, 2022
• Study Completion (ACTUAL): December 30, 2022

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (ACTUAL): October 22, 2018

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2000023930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No