NCT00651001

Brief Summary

A Food Frequency Questionnaire (FFQ), will be provided to 800 adults to assess overall fructose intake and this will be related to a number of features related to the metabolic syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass index, waist circumference, plasma lipids, blood pressure, HOMA index,fasting glucose and fasting insulin levels) and other as: CRP, fibrinogen, homocysteine and uric acid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

7 months

First QC Date

March 28, 2008

Last Update Submit

August 3, 2009

Conditions

Healthy

Keywords

fructoseleptinmetabolic syndromeblood pressureinflammationRelationship of fructose intake to leptin levelsRelationship of fructose to metabolic syndromeRelationship of fructose to inflammation parametersRelationship of fructose to blood pressure

Outcome Measures

Primary Outcomes (1)

  • Serum leptin levels as it relates to fructose intake

    Epidemiological association

Secondary Outcomes (1)

  • Relationship of metabolic syndrome features with fructose intake. This includes measuring all 5 components of metabolic syndrome, assessing insulin resistance by HOMA, and measuring some markers of inflammation (CRP, fibrinogen, homocysteine)

    Epidemiological

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

800 Adults, age 18 to 70

You may qualify if:

  • Adults, 18-70 years of age

You may not qualify if:

  • Diabetes
  • Kidney Failure
  • Heart Failure
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Unit of Mateo Orfila Hospital, Balearic Islands - Spain

Menorca, Balearic Islands, 07703, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine collections.

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 2, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

ES(1)