Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
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ClinicalTrials.gov Identifier: NCT01407627 |
Recruitment Status :
Completed
First Posted : August 2, 2011
Last Update Posted : May 19, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | July 29, 2011 | |||
First Posted Date ICMJE | August 2, 2011 | |||
Last Update Posted Date | May 19, 2022 | |||
Study Start Date ICMJE | July 2011 | |||
Actual Primary Completion Date | May 2021 (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 ] To 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.
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Original Primary Outcome Measures ICMJE |
Change in filtration fraction [ Time Frame: after 2 weeks of ingestion of fructose compared to baseline value ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ] To 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.
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Original Secondary Outcome Measures ICMJE |
change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans | |||
Official Title ICMJE | Evaluation of Fructose Ingestion and the Renin Angiotensin System in 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. 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. |
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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:
PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Other |
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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 |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
64 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date ICMJE | May 2021 | |||
Actual Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
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 ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Sofia Ahmed, University of Calgary | |||
Original Responsible Party | Sofia Ahmed MD MMSc FRCPC, University of Calgary | |||
Current Study Sponsor ICMJE | University of Calgary | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Calgary | |||
Verification Date | May 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |