Overweight and ObesityNCT00868673
The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
A study testing low fructose and Normal fructose arm in people with Overweight and Obesity and Metabolic Syndrome, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
The purpose of this study is to determine if a low fructose intake could have an impact on weight loss, uric acid levels and the components of the metabolic syndrome (glucose, cholesterol, triglycerides, insulin resistance, high blood pressure). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight and Obesity, Metabolic Syndrome, Hyperuricemia
- What is being tested?
- low fructose and Normal fructose arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2009to Feb 2010
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with a Body Mass Index (BMI) > 25. BMI defined as: Weight in kilograms divided by Height (squared) in meters.
- Residents of Mexico city
- Healthy individuals (no comorbidities or drug prescription for associated chronic diseases)
Who cannot join
- Diabetes Mellitus Type 1 or 2
- Severe Hypertension (defined as systolic blood pressure > 160 mmHg and /or diastolic blood pressure > 100 mmHg) and/or Hypertension on pharmacological treatment.
- Chronic Kidney Disease (Glomerular Filtration Rate (GFR) < 60 ml/min)
- Hepatic Damage or Advanced Disease (clinical, biochemical or histological)
- Patient receiving any pharmacological treatments for hypercholesterolemia and/or elevated triglycerides.
- Anemia (any etiology)
- Malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cardiología Igancio Chávez
Mexico City, Mexico City, 14080
About this study
The purpose of this study is to determine if a low fructose intake could have an impact on weight loss, uric acid levels and the components of the metabolic syndrome (glucose, cholesterol, triglycerides, insulin resistance, high blood pressure).
Read the detailed description
Overweight and obesity are now considered a growing public health problem in Mexico and worldwide. This epidemic has been attributed to dietary fructose consumption. Although experimental models have demonstrated a role of fructose in the development of obesity, metabolic syndrome and kidney disease, data in human models is lacking. The purpose of this study is to determine if a low fructose intake could have an impact on the components of the metabolic syndrome. The primary endpoint will be to determine the impact of low fructose on weight loss. Secondary endpoints will evaluate the impact of low fructose diet on blood pressure and cardiovascular biochemical profile.
If fructose is a causal pathway to obesity and metabolic syndrome, it may represent an important target to mitigate this important health problem.
- Conditions
- Overweight and Obesity, Metabolic Syndrome, Hyperuricemia
- Being tested
- low fructose, Normal fructose arm
- Keywords
- Role of Fructose in overweight and obesity, Fructose and metabolic syndrome, Low fructose diet study, Effects of fructose in blood pressure and hypertension, Somatometry changes observed in fructose diets, Fructose induced overweight and obesity, Fructose induced metabolic syndrome, Fructose induced hyperuricemia
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Hyperuricemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low fructoseDietary supplement
patients will receive a low fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). low fructose arm: a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of "healthy" fructose diet levels (less than 20 grams/day).Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done.
Normal fructose armDietary supplement
Also called NORMAL FRUCTOSE
patients will receive a normal fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). Normal fructose arm: participants will receive a 6 week period of normal fructose diet between 50 to 70 grams/day. Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done.
| Study group | Role | What they receive |
|---|---|---|
| Low fructose arm | Active comparator | Overweighted or obese previously healthy adults (with no other comorbidities, defined as: Diabetes (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height).
They will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and rest energy (without exercise).
This group will be assigned to a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of less than 20 grams/day fructose diet levels.
Total Time of intervention 6 weeks for each patient Receives: Dietary Supplement: low fructose |
| Normal fructose arm | Active comparator | Overweighted or obese previously healthy adults (with no other comorbidities; defined as: Diabetes Mellitus (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height).
Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet (of 15% proteins, 30% lipids and 55% carbohydrates); calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise).
This group will receive a controlled fructose diet between 50 and 70 grams/day of fructose intake.
Total time of intervention:6 weeks for each patient Receives: Dietary Supplement: Normal fructose arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatometry: including weight, height, Body Mass Index (BMI), % Body fat levels, waist and hip index, and blood pressure levels measurements performed by a single evaluator and calibrated equipment
measurements will be performed by a trained evaluator
Measured: results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient)
Secondary outcomes (1)
Blood samples: to evaluate metabolic syndrome parameters
samples will be obtained after an eight fasting period
Measured: basal and final (6 weeks interval between the basal and final results, for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Investigators
- Magdalena Madero, MD, Principal investigator, Instituto Nacional de Cardiología Ignacio Chávez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868673
- Sponsor's protocol ID
- FRUCTOSE 09-630
- Status last verified
- Nov 2009
- First submitted
- 24 Mar 2009
- Last updated
- 9 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00868673
- Acronym / sponsor ID
- FRUCTOSE 09-630
- Conditions
- Overweight and Obesity, Metabolic Syndrome, Hyperuricemia
- Keywords
- Role of Fructose in overweight and obesity, Fructose and metabolic syndrome, Low fructose diet study, Effects of fructose in blood pressure and hypertension, Somatometry changes observed in fructose diets, Fructose induced overweight and obesity, Fructose induced metabolic syndrome, Fructose induced hyperuricemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Mar 2009 (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.
The purpose of this study is to determine if a low fructose intake could have an impact on weight loss, uric acid levels and the components of the metabolic syndrome (glucose, cholesterol, triglycerides, insulin resistance, high blood pressure).
Detailed description
Overweight and obesity are now considered a growing public health problem in Mexico and worldwide. This epidemic has been attributed to dietary fructose consumption. Although experimental models have demonstrated a role of fructose in the development of obesity, metabolic syndrome and kidney disease, data in human models is lacking. The purpose of this study is to determine if a low fructose intake could have an impact on the components of the metabolic syndrome. The primary endpoint will be to determine the impact of low fructose on weight loss. Secondary endpoints will evaluate the impact of low fructose diet on blood pressure and cardiovascular biochemical profile.
If fructose is a causal pathway to obesity and metabolic syndrome, it may represent an important target to mitigate this important health problem.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fructose arm | Active comparator | Dietary Supplement: low fructoseOverweighted or obese previously healthy adults (with no other comorbidities, defined as: Diabetes (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height). They will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and rest energy (without exercise). This group will be assigned to a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of less than 20 grams/day fructose diet levels. Total Time of intervention 6 weeks for each patient |
| Normal fructose arm | Active comparator | Dietary Supplement: Normal fructose armOverweighted or obese previously healthy adults (with no other comorbidities; defined as: Diabetes Mellitus (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of >25 kilograms(weight)/ squared meters (height). Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet (of 15% proteins, 30% lipids and 55% carbohydrates); calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). This group will receive a controlled fructose diet between 50 and 70 grams/day of fructose intake. Total time of intervention:6 weeks for each patient |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals with a Body Mass Index (BMI) > 25. BMI defined as: Weight in kilograms divided by Height (squared) in meters.
- Residents of Mexico city
- Healthy individuals (no comorbidities or drug prescription for associated chronic diseases)
Key exclusion criteria (8 listed)
- Diabetes Mellitus Type 1 or 2
- Severe Hypertension (defined as systolic blood pressure > 160 mmHg and /or diastolic blood pressure > 100 mmHg) and/or Hypertension on pharmacological treatment.
- Chronic Kidney Disease (Glomerular Filtration Rate (GFR) < 60 ml/min)
- Hepatic Damage or Advanced Disease (clinical, biochemical or histological)
- Patient receiving any pharmacological treatments for hypercholesterolemia and/or elevated triglycerides.
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 |
|---|---|---|
| low fructosepatients will receive a low fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). low fructose arm: a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of "healthy" fructose diet levels (less than 20 grams/day).Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done. | Dietary supplement | Low fructose arm |
| Normal fructose armAlso: NORMAL FRUCTOSEpatients will receive a normal fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). Normal fructose arm: participants will receive a 6 week period of normal fructose diet between 50 to 70 grams/day. Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done. | Dietary supplement | Normal fructose arm |
Primary outcome
Somatometry: including weight, height, Body Mass Index (BMI), % Body fat levels, waist and hip index, and blood pressure levels measurements performed by a single evaluator and calibrated equipment
Time frame: results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient)
measurements will be performed by a trained evaluator
1 secondary outcome
Blood samples: to evaluate metabolic syndrome parameters
Time frame: basal and final (6 weeks interval between the basal and final results, for each patient)
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 9 Jul 2010.
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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.
Magdalena Madero, MD principal investigator
Instituto Nacional de Cardiología Ignacio Chávez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low fructose and Normal fructose arm in people with Overweight and Obesity and Metabolic Syndrome, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 3 inclusion and 8 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 9 Jul 2010. 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 Mexico. 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?
Somatometry: including weight, height, Body Mass Index (BMI), % Body fat levels, waist and hip index, and blood pressure levels measurements performed by a single evaluator and calibrated equipment (time frame: results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient)). 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 9 Jul 2010.