NCT00907075

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

May 21, 2009

Last Update Submit

August 21, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesnutritiondietfoods

Outcome Measures

Primary Outcomes (1)

  • Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56).

    10 weeks

Secondary Outcomes (4)

  • Change in 24 hour mean circulating glucose level from baseline to end of treatment.

    10 weeks

  • Change in fasting plasma glucose and insulin from baseline to end of treatment.

    10 weeks

  • Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment.

    10 weeks

  • Change in dietary macronutrient composition from baseline to end of treatment.

    10 weeks

Study Arms (2)

NES With Energy Restriction

ACTIVE COMPARATOR
Behavioral: NES With Energy Restriction

NES Without Energy Restriction

ACTIVE COMPARATOR
Behavioral: NES Without Energy Restriction

Interventions

NES With Energy RestrictionBEHAVIORAL

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

NES With Energy Restriction
NES Without Energy RestrictionBEHAVIORAL

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

NES Without Energy Restriction

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18-79 years of age, inclusive.
  • Diagnosis of type 2 diabetes, at least nine months prior to screening.
  • Stable use of oral hypoglycemic medication for at least two months prior to screening.
  • Body mass index (BMI) ≥25.0 and \<45.0 kg/m2 at screening.
  • Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.

You may not qualify if:

  • History or diagnosis of type 1 diabetes mellitus.
  • Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
  • Weight loss or gain \>10 lb (4.5 kg) in the two months prior to screening.
  • Abnormal laboratory test results of clinical importance.
  • History of gastrointestinal surgery for weight-reducing purposes.
  • Poorly controlled hypertension.
  • A clinically important medical or other condition.
  • Any major trauma or major surgical event within three months of screening.
  • Use of injected medications for glucose control within four weeks prior to screening.
  • Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.
  • Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
  • Pregnancy
  • Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
  • Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Provident Clinical Research & Consulting, Inc.

Addison, Illinois, 60101, United States

Location

Provident Clinical Research & Consulting, Inc.

Bloomington, Indiana, 47403, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kevin C Maki, PhD

    Provident Clinical Research & Consulting, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 22, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

US(2)