NCT00474396

Brief Summary

The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable healthy

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

April 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
Last Updated

May 16, 2007

Status Verified

May 1, 2007

First QC Date

May 14, 2007

Last Update Submit

May 15, 2007

Conditions

Healthy

Keywords

Uric acidDairyDiet

Outcome Measures

Primary Outcomes (1)

  • Lowering of serum uric acid levels

Secondary Outcomes (1)

  • Lowering of the fractional excretion of uric acid and blood pressure

Interventions

Low fat dairy dietBEHAVIORAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult volunteers
  • Coronary artery disease
  • Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
  • CHF
  • Gout
  • Lactose intolerance
  • Milk allergy
  • Women who are pregnant or lactating
  • Subjects who are on any medications except birth control pills
  • Subjects who drink more than 3 servings of beer or liquor per week.
  • Normal blood pressure ( less than 120 mmHg systolic and 80 mmHg diastolic)
  • Normal serum UA levels
  • Normal renal funcion (calculated GFR \>90ml/min)

You may not qualify if:

  • Coronary artery disease
  • Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
  • CHF
  • Gout
  • Lactose intolerance
  • Milk allergy
  • Women who are pregnant or lactating
  • Subjects who are on any medications except birth control pills
  • Subjects who drink more than 3 servings of beer or liquor per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Rafey MA, Lipkowitz MS, Leal-Pinto E, Abramson RG. Uric acid transport. Curr Opin Nephrol Hypertens. 2003 Sep;12(5):511-6. doi: 10.1097/00041552-200309000-00005.

    PMID: 12920398BACKGROUND

  • Choi HK, Atkinson K, Karlson EW, Willett W, Curhan G. Purine-rich foods, dairy and protein intake, and the risk of gout in men. N Engl J Med. 2004 Mar 11;350(11):1093-103. doi: 10.1056/NEJMoa035700.

    PMID: 15014182BACKGROUND

  • Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.

    PMID: 9099655BACKGROUND

Study Officials

  • Mohammed A Rafey, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 16, 2007

Study Start

April 1, 2005

Study Completion

October 1, 2006

Last Updated

May 16, 2007

Record last verified: 2007-05