NCT03714451

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

4.1 years

First QC Date

October 18, 2018

Last Update Submit

February 10, 2023

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Changes in weight

    day 1

  • Changes in weight

    day 14

  • Changes in weight

    day 28

  • Changes in BMI

    upon screening

  • Changes in BMI

    day 1

  • +6 more secondary outcomes

Other Outcomes (3)

  • Eating behavior

    day 1

  • Eating behavior

    day 14

  • Eating behavior

    day 28

Study Arms (2)

Onyx Group

EXPERIMENTAL

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

Dietary Supplement: onyx sorghum

Wheat Flour Group

ACTIVE COMPARATOR

Patients with T2DM will receive food products with wheat flour.

Dietary Supplement: whole wheat flour

Interventions

onyx sorghumDIETARY_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.

Onyx Group
whole wheat flourDIETARY_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.

Wheat Flour Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Yale Center for Clinical Investigation

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Renata Belfort de Aguiar, MD, PhD

    Yale School of Medicine Department of Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: double blinded randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 22, 2018

Study Start

November 1, 2018

Primary Completion

December 20, 2022

Study Completion

December 30, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

US(3)