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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714451
• Other study ID #: 2000023930
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Silver Palate Kitchens Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eating behavior	measure of food provided and returned	day 1
Other	Eating behavior	measure of food provided and returned	day 14
Other	Eating behavior	measure of food provided and returned	day 28
Primary	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
Primary	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
Primary	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	Changes in weight	change in weight from baseline	day 1
Secondary	Changes in weight	change in weight from baseline	day 14
Secondary	Changes in weight	change in weight from baseline	day 28
Secondary	Changes in BMI	change in BMI from baseline	upon screening
Secondary	Changes in BMI	change in BMI from baseline	day 1
Secondary	Changes in BMI	change in BMI from baseline	day 14
Secondary	Changes in BMI	change in BMI from baseline	day 28
Secondary	Change in glucose levels	change in blood glucose levels	upon enrollment
Secondary	Change in glucose levels	change in blood glucose levels	day 1
Secondary	Change in glucose levels	change in blood glucose levels	day 14
Secondary	Change in glucose levels	change in blood glucose levels	day 28