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Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01407627
Enrollment
64
Registered
2011-08-02
Start date
2011-07-31
Completion date
2021-05-31
Last updated
2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

human, fructose, dextrose, renin angiotensin system, kidney, renal hemodynamics

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. Cardiovascular disease in women is a significant risk factor. By having women participate who are on the birth control pill and as well as women who use non oral forms of birth control or no birth control, kidney function and cardiovascular health can be examined as it relates to in the influence oral hormones might play. How the kidney responds to the influence of sugar and fructose while a woman is on an oral birth control pill, may reveal mechanisms that could help us understand cardiovascular disease in women.

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.

Interventions

DIETARY_SUPPLEMENTFructose

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

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age≥18 years, * able to comprehend study and comply with high-salt diet * kidney disease (on the approval of their nephrologist) * on an oral birth control pill and non oral birth control and those not on birth control

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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in filtration fractionafter 2 weeks of ingestion of fructose compared to baseline valueTo examine whether the physiologic and molecular responses to an Angiotensin II challenge differ in response to fructose intake as assessed by reactive changes in circulating levels of renin and aldosterone with a graded Angiotensin II challenge.

Secondary

MeasureTime frameDescription
change in blood pressure in response to angiotensin II challengechange after 2 weeks of fructose ingestionTo examine whether the physiologic and molecular responses to an Angiotensin II challenge differ in response to fructose intake as assessed by renal and mean arterial pressure (MAP) response to an Angiotensin II challenge.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026