NCT00504478

Brief Summary

The purpose of this study is to examine the anti inflammatory effect of high complex carbohydrate diet, supplemented by omega-3 fatty acids.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 20, 2007

Status Verified

April 1, 2007

First QC Date

July 19, 2007

Last Update Submit

July 19, 2007

Conditions

Inflammation

Keywords

Inflammationcarbohydratesomega-3overweightdiet

Outcome Measures

Primary Outcomes (1)

  • markers of inflammation

    2 years

Secondary Outcomes (1)

  • difference in the pattern of monocyte gene expression

    1 year

Study Arms (2)

1

EXPERIMENTAL

8-weeks of high complex carbohydrate diet

Other: high complex carbohydrate diet

2

EXPERIMENTAL

omega-3 fatty acids supplements

Dietary Supplement: omega-3 fatty acidsOther: high complex carbohydrate diet

Interventions

omega-3 fatty acidsDIETARY_SUPPLEMENT

omega-3 supplement will be given in addition to high complex carbohydrate diet.

2
high complex carbohydrate dietOTHER
12

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy overweight volunteers

You may not qualify if:

  • Individuals who had an infective/inflammatory disease during the six month period prior to the commencement of the study, and individuals who are on treatment with statins or any steroidal or non steroidal anti inflammatory agents, except for aspirin at a dose of up to 325 mg/day, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationOverweight

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Shlomo Berliner, MD PhD

    The Tel Aviv Sauraski Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shlomo Berliner, MD PhD

CONTACT

972-3-6974961berliners@tasmc.health.gov.il

Olga Raz

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 20, 2007

Study Start

January 1, 2008

Study Completion

December 1, 2009

Last Updated

July 20, 2007

Record last verified: 2007-04