Chronic Kidney DiseaseNCT01407627
Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
A study testing Fructose in people with Chronic Kidney Disease, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Fructose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Fructose
- Keywords
- human, fructose, dextrose, renin angiotensin system, kidney, renal hemodynamics
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoseDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 2 weeks of ingestion of fructose compared to baseline value
Secondary outcomes (1)
change in blood pressure in response to angiotensin II challenge
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.
Measured: change after 2 weeks of fructose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Ahmed, University of Calgary
- Investigators
- Sofia B Ahmed, MD MMSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407627
- Sponsor's protocol ID
- UCalgary Sugar Study
- Other IDs
- AIHS, University of Calgary
- Status last verified
- May 2022
- First submitted
- 29 Jul 2011
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
- ClinicalTrials.gov ID
- NCT01407627
- Acronym / sponsor ID
- UCalgary Sugar Study
- Conditions
- Chronic Kidney Disease
- Keywords
- human, fructose, dextrose, renin angiotensin system, kidney, renal hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fructose First | Experimental | Dietary Supplement: Fructose1. 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 |
| Dextrose First | Active comparator | Dietary Supplement: Fructose1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FructoseSubjects 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 | Dietary supplement | Dextrose First, Fructose First |
Primary outcome
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.
1 secondary outcome
change in blood pressure in response to angiotensin II challenge
Time frame: change after 2 weeks of fructose ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia B Ahmed, MD MMSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose in people with Chronic Kidney Disease, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in filtration fraction (time frame: after 2 weeks of ingestion of fructose compared to baseline value). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.