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: Triple (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
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| 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 Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ) |
| First Submitted: | July 29, 2011 |
| First Posted: | August 2, 2011 |
| Last Update Posted: | May 12, 2016 |
| Last Verified: | May 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |