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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01407627 |
Recruitment Status :
Completed
First Posted : August 2, 2011
Last Update Posted : May 19, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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:
- The renal and mean arterial pressure (MAP) response to an AngII challenge.
- Reactive changes in circulating levels of renin and aldosterone with graded AngII challenge.
PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in:
- A decrease in renal and systemic sensitivity to infused AngII.
- A decrease in the reactive changes in renin and aldosterone with graded AngII challenge.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 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 |
Actual Primary Completion Date : | May 2021 |
Actual Study Completion Date : | May 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Fructose First
|
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
|
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 |
- 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.
- 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.

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
Canada, Alberta | |
University of Calgary | |
Calgary, Alberta, Canada, T2N 2T9 |
Principal Investigator: | Sofia B Ahmed, MD MMSc | University of Calgary |
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: | May 19, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
human fructose dextrose |
renin angiotensin system kidney renal hemodynamics |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |