NCT00581074

Brief Summary

This trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary intakes, appetite, and metabolic profile in overweight and obese young and middle-aged adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2006

Typical duration 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

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

2.8 years

First QC Date

December 17, 2007

Last Update Submit

July 25, 2011

Conditions

Obesity

Keywords

obesitydietweight lossmetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • weight loss

    3 months

Secondary Outcomes (1)

  • metabolic syndrome

    3 months

Study Arms (3)

G

ACTIVE COMPARATOR

grapefruit

Behavioral: diet (grapefruit or grapefruit juice)

J

ACTIVE COMPARATOR

Juice

Behavioral: diet (grapefruit or grapefruit juice)

W

PLACEBO COMPARATOR

placebo

Behavioral: diet (grapefruit or grapefruit juice)

Interventions

diet (grapefruit or grapefruit juice)BEHAVIORAL

weight loss diet

GJW

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 30-39.9

You may not qualify if:

  • Pregnant or lactating
  • On medications that are interfered with by consuming grapefruit juice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Silver HJ, Dietrich MS, Niswender KD. Effects of grapefruit, grapefruit juice and water preloads on energy balance, weight loss, body composition, and cardiometabolic risk in free-living obese adults. Nutr Metab (Lond). 2011 Feb 2;8(1):8. doi: 10.1186/1743-7075-8-8.

    PMID: 21288350DERIVED

MeSH Terms

Conditions

ObesityWeight LossMetabolic Syndrome

Interventions

Dietgrapefruit seed extract

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Heidi J Silver, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 27, 2007

Study Start

March 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations

US(1)