Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01407627
Recruitment Status : Recruiting
First Posted : August 2, 2011
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Sofia Ahmed, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: Fructose Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
Study Start Date : July 2011
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Arm Intervention/treatment
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
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
  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
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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Darlene Sola, RN, BScN    (403) 944-2745    dsola@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
Layout table for investigator information
Principal Investigator: Sofia B Ahmed, MD MMSc University of Calgary
Layout table for additonal information
Responsible Party: Sofia Ahmed, Dr. Sofia Ahmed, University of Calgary
ClinicalTrials.gov Identifier: NCT01407627    
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 Posted: August 2, 2011    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sofia Ahmed, University of Calgary:
human
fructose
dextrose
renin angiotensin system
kidney
renal hemodynamics
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency