NCT01303757

Brief Summary

The primary aim of the study is to examine insulin secretion as an effect modifier of the efficacy of a low-fat vs. low-glycemic load diet for weight loss among overweight/obese young adults in an 18-month, prospectively stratified, multi-center randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable obesity

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

February 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

4.8 years

First QC Date

February 22, 2011

Last Update Submit

February 8, 2016

Conditions

ObesityMetabolic Syndrome

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

  • Percent body fat by dual-energy x-ray absorptiometry (DXA)

    18 months

Secondary Outcomes (9)

  • Triglyceride

    18 months

  • HDL cholesterol

    18 months

  • LDL cholesterol

    18 months

  • C-reactive protein

    18 months

  • Plasminogen Activator Inhibitor-1

    18 months

  • +4 more secondary outcomes

Other Outcomes (5)

  • Serum insulin concentration 30 minutes following a standard 75-gram oral glucose load

    18 months

  • Metabolomic profile

    18 months

  • Insulin sensitivity

    18 months

  • +2 more other outcomes

Study Arms (2)

Low glycemic load diet

EXPERIMENTAL

Low glycemic load diet

Behavioral: Dietary counselling

Low fat diet

ACTIVE COMPARATOR

Low fat diet

Behavioral: Dietary counselling

Interventions

Dietary counsellingBEHAVIORAL
Low fat dietLow glycemic load diet

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 to 40 years.
  • Body mass index (BMI) ≥ 27 kg/m2.
  • Body weight ≤ 300 lb.
  • Access to a working telephone.
  • Clearance in writing from a primary care provider (i.e., physician or nurse practitioner) to rule out pre-existing medical conditions.
  • Willing and able to attend group workshops (for dietary intervention) on specified evenings.

You may not qualify if:

  • Physician diagnosis of a major medical illness or eating disorder.
  • Chronic use of any medication that may affect study outcomes (e.g., insulin-sensitizing agents).
  • Current smoking (i.e., 1 cigarette in the past week).
  • Physical, mental, or cognitive handicaps that prevent participation.
  • Another member of the family (i.e., first degree relative) or household participating in the study.
  • Planning to relocate from current area of residence during the proposed timeframe for study participation.
  • If female, planning to become pregnant during the 18 months of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Location

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Cara B Ebbeling, PhD

    Boston Children's Hospital

    STUDY DIRECTOR

  • David S Ludwig, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Leslie Fischer, PhD

    UNC Chapel Hill

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Obesity Prevention Center

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 25, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

US(2)