Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

NCT01407627 | Completed

• 3 other identifiers: UCalgary Sugar StudyAIHSUniversity of Calgary
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in filtration fraction

  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.

  after 2 weeks of ingestion of fructose compared to baseline value

Secondary Outcomes (1)

• change in blood pressure in response to angiotensin II challenge

  change after 2 weeks of fructose ingestion

Study Arms (2)

Fructose First

EXPERIMENTAL

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

Dextrose First

ACTIVE COMPARATOR

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

Interventions

Fructose DIETARY_SUPPLEMENT

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

Dextrose First; Fructose First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Fructose

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Sofia B Ahmed, MD MMSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sofia Ahmed

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 2, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)