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

Tracking Information
First Submitted Date ICMJE	July 29, 2011
First Posted Date ICMJE	August 2, 2011
Last Update Posted Date	May 4, 2018
Study Start Date ICMJE	July 2011
Estimated Primary Completion Date	September 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 1, 2011)	Change in filtration fraction [ Time Frame: after 2 weeks of ingestion of fructose compared to baseline value ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01407627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 1, 2011)	change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans
Official Title ICMJE	Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans
Brief Summary	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 humans.
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: The renal and mean arterial pressure (MAP) response to an AngII challenge.; Reactive changes in circulating levels of renin and aldosterone with graded AngII challenge. PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in: A decrease in renal and systemic sensitivity to infused AngII.; A decrease in the reactive changes in renin and aldosterone with graded AngII challenge.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Other
Condition ICMJE	Chronic Kidney Disease
Intervention ICMJE	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
Study Arms	Experimental: Fructose First Study Day 1 - measurement of renal hemodynamics and blood pressure Subjects will ingest fructose 200g daily x 14d Study Day 2 - measurement of renal hemodynamics Minimum 1 week "washout" period Subjects will ingest dextrose 200g daily x 14d Study Day 3 - measurement of renal hemodynamics and blood pressure Intervention: Dietary Supplement: Fructose; Active Comparator: Dextrose First Study Day 1 - measurement of renal hemodynamics and blood pressure Subjects will ingest dextrose 200g daily x 14d Study Day 2 - measurement of renal hemodynamics Minimum 1 week "washout" period Subjects will ingest fructose 200g daily x 14d Study Day 3 - measurement of renal hemodynamics and blood pressure Intervention: Dietary Supplement: Fructose
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: August 1, 2011)	30
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 2020
Estimated Primary Completion Date	September 2020 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01407627
Other Study ID Numbers ICMJE	UCalgary Sugar Study; AIHS ( Other Grant/Funding Number: Establishment Grant ); University of Calgary ( Other Grant/Funding Number: Dept of Med Developmental Fund )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Sofia Ahmed, University of Calgary
Study Sponsor ICMJE	University of Calgary
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Sofia B Ahmed, MD MMSc University of Calgary
PRS Account	University of Calgary
Verification Date	May 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP