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CompletedNCT04168541Updated Nov 19, 2019

Glycemic Response in Persons With Type 2 Diabetes Mellitus

An interventional study of Oral Nutrition Supplement in Diabetes Mellitus, Type 2, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 14 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Subject inclusion criteria

All subjects must comply with all the following inclusion criteria:

  • Age 20-75 years
  • Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg
  • Hematocrit levels within normal limits
  • Having obtained his/her informed consent

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    Oral Nutrition Supplement A

    Product containing calories from carbohydrate, protein, and fat

    Other: Oral Nutrition Supplement

  • Active comparator
    Oral Nutrition Supplement B

    Product containing calories from carbohydrate, protein, and fat

    Other: Oral Nutrition Supplement

  • Active comparator
    Oral Nutrition Supplement C

    Product containing calories from carbohydrate, protein, and fat

    Other: Oral Nutrition Supplement

  • Active comparator
    Oral Nutrition Supplement D

    Product containing calories from carbohydrate, protein, and fat

    Other: Oral Nutrition Supplement

  • Active comparator
    Oral Nutrition Supplement E

    Product containing calories from carbohydrate, protein, and fat

    Other: Oral Nutrition Supplement

  • Active comparator
    Oral Nutrition Supplement F

    Product containing calories from carbohydrate, protein, and fat

    Other: Oral Nutrition Supplement

Interventions

  • OtherOral Nutrition Supplement

    Product intake of oral nutrition supplement provided

06

What researchers measure

Primary outcomes

  1. Area under the blood glucose curve (ACU 0-240 minutes)

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

Secondary outcomes

  1. Area under the insulin curves (AUC 0-240)

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

  2. Insulinogenic index [Change in Ins30/Change in Glu30]

    Time frame: [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]

07

Study locations

1 site
  • Orange County Research Center
    Tustin, California 92780, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04168541
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Nov 19, 2019
Start date
Feb 5, 2018
Primary completion
Apr 18, 2018
Completion
Apr 18, 2018
Last update
Nov 19, 2019

Study contacts

Joel Neutel, MD
principal investigator · Orange County Research Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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