Fructose Metabolism DisorderNCT03352596
Low Fructose Diet in Diabetes Type 2
A study testing low frutose diet in people with Fructose Metabolism Disorder, run by National Nutrition and Food Technology Institute.
Trial summary
Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran. Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Fructose Metabolism Disorder
- What is being tested?
- low frutose diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Nov 2017
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 70-40 years
- body mass index(BMI) between 18.5 and 27
- Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years)
Who cannot join
- Pregnancy and lactation
- Thyroid gland disorders
- Kidney disease and inflammation
- Follow the weight loss regimen 6 months before starting the study
- Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3
- Taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs
About this study
Official title: Effects of Low Fructose Diet on Glycemic Control in Patients With Type 2 Diabetes
Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran. Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. New research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates. Fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels. Therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..
- Conditions
- Fructose Metabolism Disorder
- Being tested
- low frutose diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low frutose dietOther
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Eight weeks of low fructose diet with a maximum of 12 g of fructose Receives: Other: low frutose diet |
| control group | No intervention | Eight weeks of regular diabetic diet with a 15%pro 30%fat 55%CHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood suger(FBS)
Measured: 8 weeks
Homeostatic model assessment and insulin resistance(HOMA-IR)
Measured: 8weeks
insulin
Measured: 8 weeks
Secondary outcomes (5)
Triglyceride
Measured: 8 weeks
Total cholestrole
Measured: 8 weeks
LDL-C
Measured: 8 weeks
HDL-C
Measured: 8 weeks
Blood pressure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jan 2017
- Primary completion1 Oct 2017
- Study completion30 Nov 2017 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352596
- Sponsor's protocol ID
- 93567
- Status last verified
- Aug 2017
- First submitted
- 13 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Fructose Diet on Glycemic Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03352596
- Acronym / sponsor ID
- 93567
- Conditions
- Fructose Metabolism Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 24 Nov 2017 (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.
Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran. Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. New research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates. Fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels. Therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: low frutose dietEight weeks of low fructose diet with a maximum of 12 g of fructose |
| control group | No intervention | –Eight weeks of regular diabetic diet with a 15%pro 30%fat 55%CHO |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 70-40 years
- body mass index(BMI) between 18.5 and 27
- Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years)
Key exclusion criteria (6 listed)
- Pregnancy and lactation
- Thyroid gland disorders
- Kidney disease and inflammation
- Follow the weight loss regimen 6 months before starting the study
- Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3
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 frutose diet | Other | intervention group |
Primary outcome
fasting blood suger(FBS)
Time frame: 8 weeks
Homeostatic model assessment and insulin resistance(HOMA-IR)
Time frame: 8weeks
insulin
Time frame: 8 weeks
5 secondary outcomes
Triglyceride
Time frame: 8 weeks
Total cholestrole
Time frame: 8 weeks
LDL-C
Time frame: 8 weeks
HDL-C
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing low frutose diet in people with Fructose Metabolism Disorder, run by National Nutrition and Food Technology Institute.
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 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
fasting blood suger(FBS) (time frame: 8 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 24 Nov 2017.