NCT00194246

Brief Summary

We are interested in testing differences in cognitive function and food reactivity at various time points in individuals following low and high carbohydrate diets. We wish to achieve an understanding of these time-specific differences using repeated measures analysis of variance (ANOVA), with diet condition (low vs. high carbohydrate) as a between subject factor and time as a within-subject factor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 1, 2013

Status Verified

August 1, 2007

Enrollment Period

6.6 years

First QC Date

September 13, 2005

Last Update Submit

June 28, 2013

Conditions

Cognitive PerformanceFood Cravings

Outcome Measures

Primary Outcomes (1)

  • the relationships between cognitive and physiological reactivity to food and non-food cues

    2 year period

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all participants who took part in the Safety and Efficacy of Low and High Carbohydrate Diets study

You may qualify if:

  • Body mass index between 30 and 40
  • Live and work within 1 hour of the study site
  • Stable psychological status

You may not qualify if:

  • History of heart disease, heart attack, or stroke
  • Blood pressure \> 140/90 mmHG
  • Abnormal cholesterol levels
  • Significant psychiatric illness
  • Any medication that affects weight or metabolic rate
  • Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e. diabetes, thyroid disease or cancer).
  • Currently using antidepressants, steroids, tobacco or illegal drugs
  • Pregnant, breastfeeding, or planning pregnancy
  • lb change in weight within 6 months of study entry
  • History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
  • History of protein wasting diseases or gout
  • Severe arthritis
  • Osteoporosis
  • Certain types of hormone replacement therapy
  • Currently following a vegetarian diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

salivary cortisol

Study Officials

  • Gary D Foster, PhD

    Temple University - Center for Obesity Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

August 1, 2003

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 1, 2013

Record last verified: 2007-08

Locations

US(1)