Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus

NCT00907075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2012-08-22

No results posted yet for this study

Summary

The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.

Conditions

Interventions

BEHAVIORAL

NES With Energy Restriction

The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.

BEHAVIORAL

NES Without Energy Restriction

The NES will be administered based upon the individual's calculated daily energy requirement.

Sponsors & Collaborators

  • Provident Clinical Research

    collaborator OTHER
  • Mondelēz International, Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin C Maki, PhD · Provident Clinical Research & Consulting, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00907075 on ClinicalTrials.gov