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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Calgary
Sponsor:
Information provided by (Responsible Party):
Sofia Ahmed, University of Calgary
ClinicalTrials.gov Identifier:
NCT01407627
First received: July 29, 2011
Last updated: May 10, 2016
Last verified: May 2016
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
 Dietary Supplement: Fructose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in filtration fraction [ Time Frame: after 2 weeks of ingestion of fructose compared to baseline value ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ] [ Designated as safety issue: No ]
Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 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

Detailed Description:

PRIMARY AIM: To examine whether the physiologic and molecular responses to Angiotensin II (AngII) challenge differ in response to fructose intake as assessed by two independent means:

  1. The renal and mean arterial pressure (MAP) response to an AngII challenge.
  2. Reactive changes in circulating levels of renin and aldosterone with graded AngII challenge.

PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in:

  1. A decrease in renal and systemic sensitivity to infused AngII.
  2. A decrease in the reactive changes in renin and aldosterone with graded AngII challenge.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407627

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Darlene Sola, RN, BScN    (403) 944-2745    dsola@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Sofia B Ahmed, MD MMSc University of Calgary
  More Information

Responsible Party: Sofia Ahmed, Dr. Sofia Ahmed, University of Calgary
ClinicalTrials.gov Identifier: NCT01407627     History of Changes
Other Study ID Numbers: UCalgary Sugar Study  AIHS  University of Calgary 
Study First Received: July 29, 2011
Last Updated: May 10, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Calgary:
human
fructose
dextrose
 renin angiotensin system
kidney
renal hemodynamics

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on September 27, 2016