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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blinded randomized

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double blinded

Study Groups

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Onyx Group

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

Group Type EXPERIMENTAL

onyx sorghum

Intervention Type DIETARY_SUPPLEMENT

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.

Wheat Flour Group

Patients with T2DM will receive food products with wheat flour.

Group Type ACTIVE_COMPARATOR

whole wheat flour

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes