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Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans
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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 Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) |
| Official Title: | Evaluation of Fructose Ingestion and the Renin Angiotensin System in Healthy Humans |
- Change in filtration fraction [ Time Frame: after 2 weeks of ingestion of fructose compared to baseline value ]
- change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ]
| 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
|
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
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01407627
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Contact: Darlene Sola, RN, BScN (403) 944-2745 dsola@ucalgary.ca | |
| 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 ( Other Grant/Funding Number: Establishment Grant ) University of Calgary ( Other Grant/Funding Number: Dept of Med Developmental Fund ) |
| Study First Received: | July 29, 2011 |
| Last Updated: | May 10, 2016 |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by Sofia Ahmed, University of Calgary:
|
human fructose dextrose |
renin angiotensin system kidney renal hemodynamics |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 27, 2017