Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

• ClinicalTrials.gov Identifier: NCT01407627
• Recruitment Status: Recruiting
• First Posted: August 2, 2011
• Last Update Posted: November 5, 2020
• Sponsor: University of Calgary
• Information provided by (Responsible Party): Sofia Ahmed, University of Calgary

Tracking Information

• First Submitted Date: July 29, 2011
• First Posted Date: August 2, 2011
• Last Update Posted Date: November 5, 2020
• Study Start Date: July 2011
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 22, 2019)

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.

• Original Primary Outcome Measures (submitted: August 1, 2011): Change in filtration fraction [ Time Frame: after 2 weeks of ingestion of fructose compared to baseline value ]

Current Secondary Outcome Measures (submitted: May 22, 2019)

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.

• Original Secondary Outcome Measures (submitted: August 1, 2011): 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: Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
• Official Title: 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: Chronic Kidney Disease

Intervention

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

Study Arms

• 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
  Intervention: Dietary Supplement: Fructose
• 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
  Intervention: Dietary Supplement: Fructose

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 22, 2019): 60
• Original Estimated Enrollment (submitted: August 1, 2011): 30
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Canada

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sofia Ahmed, University of Calgary
• Study Sponsor: University of Calgary
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sofia B Ahmed, MD MMSc; University of Calgary

• PRS Account: University of Calgary
• Verification Date: November 2020