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

This study is currently recruiting participants.

Verified July 2011 by University of Calgary

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 29, 2011

Last Updated Date

August 18, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ] [ Designated as safety issue: No ]

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 healthy humans.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Condition ^ICMJE

Renin Angiotensin System
Human
Renal Hemodynamics

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 Arm (s)

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

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

Completion Date

Not Provided

Estimated Primary Completion Date

July 2013 (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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01407627

Other Study ID Numbers ^ICMJE

UCalgary Sugar Study, AIHS, University of Calgary

Has Data Monitoring Committee

Responsible Party

Sofia Ahmed MD MMSc FRCPC, 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

Information Provided By

University of Calgary

Verification Date

July 2011

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

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