NCT03155867

Brief Summary

This will be a randomized, cross-over design. Subjects will be randomized to one of six interventions on six separate study days, 1 week apart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 5, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed
Last Updated

July 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

May 15, 2017

Last Update Submit

June 29, 2017

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Area under the blood glucose curve (AUC 0-240)

    Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcomes (3)

  • Area under the insulin curves (AUC 0-240)

    Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

  • Insulinogenic index [Change in Ins30/Change in Glu30]

    Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

  • AUC (0-30min) for insulin

    Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Study Arms (6)

Meal replacement A

ACTIVE COMPARATOR
Other: Meal replacement

Meal replacement B

ACTIVE COMPARATOR
Other: Meal replacement

Meal replacement C

ACTIVE COMPARATOR
Other: Meal replacement

Meal replacement D

ACTIVE COMPARATOR
Other: Meal replacement

Meal replacement E

ACTIVE COMPARATOR
Other: Meal replacement

Meal replacement F

ACTIVE COMPARATOR
Other: Meal replacement

Interventions

Meal replacementOTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Meal replacement AMeal replacement BMeal replacement CMeal replacement DMeal replacement EMeal replacement F

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-75 yrs
  • Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg
  • Hematocrit levels within normal limits

You may not qualify if:

  • Abnormal thyroid function
  • Creatinine \>2.0 mg/dL
  • Potassium \<3.5 mEq/L
  • Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
  • Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
  • Unable to give informed consent or follow instructions
  • Current insulin therapy or insulin therapy within the past month
  • Patient who are pregnant
  • Allergies to milk, soy or any component of the test product
  • Patient who in the Investigators assessment cannot be expected to comply with treatment
  • Currently participating or having participated in another clinical trial.
  • Patients with Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Joel Neutel, MD

    Orange County Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 16, 2017

Study Start

April 5, 2017

Primary Completion

May 18, 2017

Study Completion

May 18, 2017

Last Updated

July 2, 2017

Record last verified: 2017-05

Locations

US(1)