Fructose Metabolism DisorderNCT03939130
Fructose Rich Diet and Endothelial Function
A study testing Fructose, Glucose and Fructose and exercise in people with Fructose Metabolism Disorder and Fructose Rich Diet, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Cardiometabolic diseases have been associated with high consumption of sweetened beverages. These products are responsible for the largest portion of the total consumption of fructose in the diet and it is suggested that excessive intake of this monosaccharide may contribute to the development of risk factors for… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fructose Metabolism Disorder, Fructose Rich Diet, Metabolic Disease
- What is being tested?
- Fructose, Glucose and Fructose and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2018to 23 Dec 2018
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women;
- Not engaged in regular exercises;
- Aged between 19 and 35 years;
- Body mass index (BMI) of less than 30kg / m².
Who cannot join
- Individuals with BMI below 18kg / m² and greater than 30kg / m²;
- Smokers;
- Dyslipidemic;
- Diabetic;
- Hypertensive;
- Alcohol use;
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- Appetite suppressants use;
- Medications use;
- Supplements use;
- Chronic disease that impedes the performance of physical exercise.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Effects of Fructose Rich Diet Associated With Aerobic Training on Uric Acid Levels and Endothelial Function
Cardiometabolic diseases have been associated with high consumption of sweetened beverages. These products are responsible for the largest portion of the total consumption of fructose in the diet and it is suggested that excessive intake of this monosaccharide may contribute to the development of risk factors for these diseases due to differences in metabolism relative to glucose. However, there is a lack of data in the literature demonstrating the deleterious effects of excessive fructose consumption on vasodilation and whether aerobic training may be able to prevent or mitigate these damages in humans. Therefore, the aim of the study will be to verify the effect of 4 weeks of high fructose diet associated with aerobic training on uric acid levels and its influence on markers related to oxidative stress and vasodilatation. Twenty-one sedentary men and women, aged between 19 and 35 years, will be submitted to 4 weeks of intervention. In a randomized way, subjects will be divided into 3 groups: high fructose diet, high glucose diet and high fructose diet and exercise. Blood samples will be taken before, in the middle and after the intervention to verify the concentrations of uric acid, superoxide dismutase enzyme, thiobarbituric acid, nitrite / nitrate, lipid profile, glucose, insulin, C-reactive protein and endothelin-1. In addition, flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity index, oral glucose tolerance test, 24-hour blood pressure, heart rate variability and body composition will be analyzed. The comparisons will be performed through the Generalized Estimates of Equations, adopting the factors group and time. The Bonferroni post-hoc will be used to identify differences. The accepted level of significance will be 5%.
- Being tested
- Fructose, Glucose, Fructose and exercise
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoseDietary supplement
Consumption of 1.0g / kg of body mass / day of fructose.
GlucoseDietary supplement
Consumption of 1.0g / kg of body mass / day of glucose.
Fructose and exerciseOther
Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| Fructose-rich diet | Experimental | Subjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive fructose based beverage, prepared as a solution with 10% fructose, water and flavoring powder, totaling 1.0g / kg of body mass / day of fructose. Receives: Dietary Supplement: Fructose |
| Glucose-rich diet | Active comparator | Subjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive glucose based beverage, prepared as a solution with 10% glucose, water and flavoring powder, totaling 1.0g / kg of body mass / day of glucose. Receives: Dietary Supplement: Glucose |
| Fructose-rich diet and exercise | Experimental | The subjects will perform the same protocol described in the intervention Fructose-rich diet, except for the inclusion of the physical exercise. During the 4-week intervention, participants will perform three sessions a week of 60 minutes of aerobic exercise at 60% of VO2 peak on cycle ergometer. Receives: Other: Fructose and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilatation
Measured: 4 weeks
Concentration of Uric Acid
Measured: 4 weeks
Concentration of Nitrite / Nitrate
Measured: 4 weeks
Secondary outcomes (16)
Concentration of Superoxide Dismutase Enzyme
Measured: 4 weeks
Concentration of Substances Reactive to Thiobarbituric Acid
Oxidative stress outcome
Measured: 4 weeks
Concentration of Total Cholesterol
Measured: 4 weeks
Concentration of Triglycerides
Measured: 4 weeks
Concentration of Low-Density Lipoprotein
Measured: 4 weeks
Concentration of High-Density Lipoprotein
Measured: 4 weeks
Concentration of Glucose
Measured: 4 weeks
Concentration of Insulin
Measured: 4 weeks
HOMA-IR
Measured: 4 weeks
HOMA-B
Measured: 4 weeks
Insulin Sensitivity
Oral glucose tolerance test
Measured: 4 weeks
Concentration of C-Reactive Protein
Measured: 4 weeks
Concentration of Endothelin-1
Measured: 4 weeks
24-hour Blood Pressure
Measured: 4 weeks
Heart Rate Variability
Measured: 4 weeks
Body Fat
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jun 2018
- Primary completion23 Dec 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fructose Metabolism DisorderStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939130
- Sponsor's protocol ID
- 84642318.8.0000.5347
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fructose Rich Diet Associated With Aerobic Training on Uric Acid Levels and Endothelial Function
- ClinicalTrials.gov ID
- NCT03939130
- Acronym / sponsor ID
- 84642318.8.0000.5347
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 6 May 2019 (actual)
- 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.
Cardiometabolic diseases have been associated with high consumption of sweetened beverages. These products are responsible for the largest portion of the total consumption of fructose in the diet and it is suggested that excessive intake of this monosaccharide may contribute to the development of risk factors for these diseases due to differences in metabolism relative to glucose. However, there is a lack of data in the literature demonstrating the deleterious effects of excessive fructose consumption on vasodilation and whether aerobic training may be able to prevent or mitigate these damages in humans. Therefore, the aim of the study will be to verify the effect of 4 weeks of high fructose diet associated with aerobic training on uric acid levels and its influence on markers related to oxidative stress and vasodilatation. Twenty-one sedentary men and women, aged between 19 and 35 years, will be submitted to 4 weeks of intervention. In a randomized way, subjects will be divided into 3 groups: high fructose diet, high glucose diet and high fructose diet and exercise. Blood samples will be taken before, in the middle and after the intervention to verify the concentrations of uric acid, superoxide dismutase enzyme, thiobarbituric acid, nitrite / nitrate, lipid profile, glucose, insulin, C-reactive protein and endothelin-1. In addition, flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity index, oral glucose tolerance test, 24-hour blood pressure, heart rate variability and body composition will be analyzed. The comparisons will be performed through the Generalized Estimates of Equations, adopting the factors group and time. The Bonferroni post-hoc will be used to identify differences. The accepted level of significance will be 5%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fructose-rich diet | Experimental | Dietary Supplement: FructoseSubjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive fructose based beverage, prepared as a solution with 10% fructose, water and flavoring powder, totaling 1.0g / kg of body mass / day of fructose. |
| Glucose-rich diet | Active comparator | Dietary Supplement: GlucoseSubjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive glucose based beverage, prepared as a solution with 10% glucose, water and flavoring powder, totaling 1.0g / kg of body mass / day of glucose. |
| Fructose-rich diet and exercise | Experimental | Other: Fructose and exerciseThe subjects will perform the same protocol described in the intervention Fructose-rich diet, except for the inclusion of the physical exercise. During the 4-week intervention, participants will perform three sessions a week of 60 minutes of aerobic exercise at 60% of VO2 peak on cycle ergometer. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women;
- Not engaged in regular exercises;
- Aged between 19 and 35 years;
- Body mass index (BMI) of less than 30kg / m².
Key exclusion criteria (10 listed)
- Individuals with BMI below 18kg / m² and greater than 30kg / m²;
- Smokers;
- Dyslipidemic;
- Diabetic;
- Hypertensive;
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 |
|---|---|---|
| FructoseConsumption of 1.0g / kg of body mass / day of fructose. | Dietary supplement | Fructose-rich diet |
| GlucoseConsumption of 1.0g / kg of body mass / day of glucose. | Dietary supplement | Glucose-rich diet |
| Fructose and exerciseConsumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise. | Other | Fructose-rich diet and exercise |
Primary outcome
Flow Mediated Dilatation
Time frame: 4 weeks
Concentration of Uric Acid
Time frame: 4 weeks
Concentration of Nitrite / Nitrate
Time frame: 4 weeks
16 secondary outcomes
Concentration of Superoxide Dismutase Enzyme
Time frame: 4 weeks
Concentration of Substances Reactive to Thiobarbituric Acid
Time frame: 4 weeks
Concentration of Total Cholesterol
Time frame: 4 weeks
Concentration of Triglycerides
Time frame: 4 weeks
Concentration of Low-Density Lipoprotein
Time frame: 4 weeks
Concentration of High-Density Lipoprotein
Time frame: 4 weeks
Concentration of Glucose
Time frame: 4 weeks
Concentration of Insulin
Time frame: 4 weeks
HOMA-IR
Time frame: 4 weeks
HOMA-B
Time frame: 4 weeks
Insulin Sensitivity
Time frame: 4 weeks
Concentration of C-Reactive Protein
Time frame: 4 weeks
Concentration of Endothelin-1
Time frame: 4 weeks
24-hour Blood Pressure
Time frame: 4 weeks
Heart Rate Variability
Time frame: 4 weeks
Body Fat
Time frame: 4 weeks
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 6 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Glucose and Fructose and exercise in people with Fructose Metabolism Disorder and Fructose Rich Diet, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 10 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 6 May 2019. 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 Brazil. 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?
Flow Mediated Dilatation (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 6 May 2019.