NCT01176084

Brief Summary

The purposes of this study are: To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat. To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
Last Updated

August 20, 2010

Status Verified

July 1, 2010

Enrollment Period

3.8 years

First QC Date

August 4, 2010

Last Update Submit

August 19, 2010

Conditions

Obesity

Keywords

low carbohydrate dietobesitymoderate exercisemen

Outcome Measures

Primary Outcomes (1)

  • insulin levels

Secondary Outcomes (3)

  • body composition

  • lipid profile

  • body weight

Study Arms (2)

low carbohydrate diet

EXPERIMENTAL
Behavioral: low carbohydrate diet

diet & exercise

EXPERIMENTAL
Behavioral: low carbohydrate diet and exercise

Interventions

low carbohydrate dietBEHAVIORAL
low carbohydrate diet
low carbohydrate diet and exerciseBEHAVIORAL
diet & exercise

Eligibility Criteria

Age21 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • years
  • body mass index (BMI) 27-40kg/m2
  • not currently losing weight
  • physically able to exercise at moderate intensity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health and Medical Sciences, University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

MeSH Terms

Conditions

ObesityMultiple Endocrine Neoplasia Type 1

Interventions

Diet, Carbohydrate-RestrictedExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rebecca Hiscutt, PhD

    University of Surrey

    PRINCIPAL INVESTIGATOR

  • Helen D Truby, PhD

    Monash University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2010

First Posted

August 5, 2010

Study Start

January 1, 2004

Primary Completion

October 1, 2007

Study Completion

February 1, 2008

Last Updated

August 20, 2010

Record last verified: 2010-07

Locations

GB(1)