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Completed

NCT Number: NCT03714451

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).

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Center for Clinical Investigation, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

onyx sorghum

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.

whole wheat flour

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.

Primary outcomes

  1. Change in glycemic variability

    Time frame: day 1

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

  2. Change in glycemic variability

    Time frame: 14 days

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

  3. Change in glycemic variability

    Time frame: 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 outcomes

  1. Changes in weight

    Time frame: day 1

    change in weight from baseline

  2. Changes in weight

    Time frame: day 14

    change in weight from baseline

  3. Changes in weight

    Time frame: day 28

    change in weight from baseline

  4. Changes in BMI

    Time frame: upon screening

    change in BMI from baseline

  5. Changes in BMI

    Time frame: day 1

    change in BMI from baseline

  6. Changes in BMI

    Time frame: day 14

    change in BMI from baseline

  7. Changes in BMI

    Time frame: day 28

    change in BMI from baseline

  8. Change in glucose levels

    Time frame: upon enrollment

    change in blood glucose levels

  9. Change in glucose levels

    Time frame: day 1

    change in blood glucose levels

  10. Change in glucose levels

    Time frame: day 14

    change in blood glucose levels

  11. Change in glucose levels

    Time frame: day 28

    change in blood glucose levels

Other outcomes

  1. Eating behavior

    Time frame: day 1

    measure of food provided and returned

  2. Eating behavior

    Time frame: day 14

    measure of food provided and returned

  3. Eating behavior

    Time frame: day 28

    measure of food provided and returned

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Silver Palate Kitchens Inc.

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2018
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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