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Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01407627
First received: July 29, 2011
Last updated: August 18, 2011
Last verified: July 2011

July 29, 2011
August 18, 2011
July 2011
July 2013   (final data collection date for primary outcome measure)
Change in filtration fraction [ Time Frame: after 2 weeks of ingestion of fructose compared to baseline value ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01407627 on ClinicalTrials.gov Archive Site
change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans
Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans

Fructose is an ingredient that is added to many of our foods. It is a cheaper, sweeter additive that can be found in everything from soda pop to yogurt to granola bars. In the last few years a significant number of studies have been published linking consumption of fructose with obesity, hypertension and more recently, kidney and cardiovascular disease.

Animal studies show a strong link between excessive ingestion of fructose and the development of kidney and cardiovascular disease mediated by the renin angiotensin system, a hormonal system whose activation is detrimental to both the kidney and the heart. There has been very little research done on the potentially pathophysiological relationship between a high fructose diet and kidney and cardiovascular disease in humans.

The investigators hypothesize that ingestion of fructose will result in upregulation of the renin angiotensin system in healthy humans.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Renin Angiotensin System
  • Human
  • Renal Hemodynamics
Dietary Supplement: Fructose

Subjects will be randomized to one of 2 sequences:

Sequence 1: Fructose (intervention) 200g daily x 14d followed by Dextrose (control) 200g daily x 14d Sequence 2: Dextrose (control) 200g daily x 14d followed by Fructose (intervention) 200g daily x 14d

  • Experimental: Fructose First
    1. Study Day 1 - measurement of renal hemodynamics and blood pressure
    2. Subjects will ingest fructose 200g daily x 14d
    3. Study Day 2 - measurement of renal hemodynamics
    4. Minimum 1 week "washout" period
    5. Subjects will ingest dextrose 200g daily x 14d
    6. Study Day 3 - measurement of renal hemodynamics and blood pressure
    Intervention: Dietary Supplement: Fructose
  • Active Comparator: Dextrose First
    1. Study Day 1 - measurement of renal hemodynamics and blood pressure
    2. Subjects will ingest dextrose 200g daily x 14d
    3. Study Day 2 - measurement of renal hemodynamics
    4. Minimum 1 week "washout" period
    5. Subjects will ingest fructose 200g daily x 14d
    6. Study Day 3 - measurement of renal hemodynamics and blood pressure
    Intervention: Dietary Supplement: Fructose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age≥18 years,
  • able to comprehend study and comply with high-salt diet

Exclusion Criteria:

  • cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
  • cerebrovascular disease (transient ischemic attacks or stroke)
  • kidney disease (estimated GFR<60 using the MDRD formula36, proteinuria or hematuria on dipstick)
  • hypertension (BP>140/90 or use of antihypertensive medications)
  • diabetes mellitus (defined by history, use of hypoglycemic agents or a fasting glucose >7mmol/L)
  • hyperlipidemia (LDL >4.5mmol/L or use of lipid-lowering agents)
  • pregnancy
Both
18 Years and older
Yes
Canada
 
NCT01407627
UCalgary Sugar Study, AIHS, University of Calgary
No
Sofia Ahmed MD MMSc FRCPC, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Sofia B Ahmed, MD MMSc University of Calgary
University of Calgary
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP