Metabolic SyndromeAGEsNCT03147339
The Effects of Restricted Dietary of AGEs on the Glycemic Control, Oxidative Stress and Inflammation
A study testing AGEs restricted diet in people with Metabolic Syndrome, run by Dr Azita Hekmatdoost at 1 site in Iran.
Trial summary
To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy diet and no changing in physical activity… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- AGEs restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 10 Jan 2017to Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years of age
- having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
Who cannot join
- history of allergy
- clinically diagnosed renal, pituitary, thyroid, infections and inflammations, cancer and using of insulin, using multivitamin mineral and vitamin B6 suplements.
- Using any
- history of cancers.
- pregnancy, lactation.
Trial locations and contacts
1 site in 1 country.
Iran1 site
National Nutrition and Food Technology Research Institute
Tehrān, Tehran Province, 19395-4741
About this study
Official title: The Effects of Restricted Dietary of Advanced Glycation End Products(AGEs) on the Glycemic Control, Oxidative Stress and Systemic-inflammation in Patients With Metabolic.
To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy diet and no changing in physical activity pattern.Parameters related to metabolic syndrome, anthropocentric factors, oxidative stress(Malondialdehyde), CML(AGEs factor in blood) and systemic inflammation factors (hs-CRP وTNF-α ) will be measured at the baseline and at the end of the study.
Read the detailed description
Metabolic syndrome (MS) is a cluster of cardiovascular risk factor abnormalities associated with increased risk of type 2 diabetes mellitus, cardiovascular disease, and all-cause mortality. Non-enzymatic glycation plays an important role in the development of physiological and pathophysiological processes such as aging, diabetes, atherosclerosis, and chronic renal failure. Preventing glycation can minimize diabetic complications. Advanced glycation end products (AGEs) are formed endogenously when the carbonyl groups of reducing sugars nonenzymatically react with the free amino groups on proteins. AGEs are generated in vivo as a normal consequence of metabolism, but their formation is accelerated under conditions of hyperglycemia, hyperlipidemia and increased oxidative stress. It can also form in food processing and the variety and the amount of dietary AGEs (dAGE) depend on food nutrients, the heating used in food processing, pH conditions, presence of some metal ions (Cu++, Fe++) and water content. In this study 2 groups of metabolic syndrome patients(22 in each group) will receive same low calorie diet and one of the groups plus restricted dietary AGEs according to the international references.Along 8 weeks the investigators will talk to each patient by phone and every months the participants will come and the investigators will take anthropocentric measurements and the recommendations for diets will review. The three-day 24-hour recall food questionnaire will take at first,middle and the end of program.
- Conditions
- Metabolic Syndrome
- Being tested
- AGEs restricted diet
- Keywords
- AGEs( Advanced glycation end products)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGEs restricted dietOther
Diet modification to reduce advanced glycation end products in diet. for example to change ways of cooking, time of cooking and also omit some foods.
| Study group | Role | What they receive |
|---|---|---|
| AGEs restricted diet | Experimental | Low calorie diet + AGEs restricted diet Receives: Other: AGEs restricted diet |
| control | No intervention | Low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Levels of carboxymethyl-lysine(CML)
specific serum AGEs
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 posted10 May 2017
- Study start10 Jan 2017
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Azita Hekmatdoost
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
- Investigators
- National Nutrition and Food Technology Research Institute, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147339
- Sponsor's protocol ID
- NNFTRI691
- Acronym
- AGEs
- Status last verified
- Sep 2017
- First submitted
- 30 Apr 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Restricted Dietary of Advanced Glycation End Products(AGEs) on the Glycemic Control, Oxidative Stress and Systemic-inflammation in Patients With Metabolic.
- ClinicalTrials.gov ID
- NCT03147339
- Acronym / sponsor ID
- AGEs / NNFTRI691
- Conditions
- Metabolic Syndrome
- Keywords
- AGEs( Advanced glycation end products)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr Azita HekmatdoostUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 May 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.
To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy diet and no changing in physical activity pattern.Parameters related to metabolic syndrome, anthropocentric factors, oxidative stress(Malondialdehyde), CML(AGEs factor in blood) and systemic inflammation factors (hs-CRP وTNF-α ) will be measured at the baseline and at the end of the study.
Detailed description
Metabolic syndrome (MS) is a cluster of cardiovascular risk factor abnormalities associated with increased risk of type 2 diabetes mellitus, cardiovascular disease, and all-cause mortality. Non-enzymatic glycation plays an important role in the development of physiological and pathophysiological processes such as aging, diabetes, atherosclerosis, and chronic renal failure. Preventing glycation can minimize diabetic complications. Advanced glycation end products (AGEs) are formed endogenously when the carbonyl groups of reducing sugars nonenzymatically react with the free amino groups on proteins. AGEs are generated in vivo as a normal consequence of metabolism, but their formation is accelerated under conditions of hyperglycemia, hyperlipidemia and increased oxidative stress. It can also form in food processing and the variety and the amount of dietary AGEs (dAGE) depend on food nutrients, the heating used in food processing, pH conditions, presence of some metal ions (Cu++, Fe++) and water content. In this study 2 groups of metabolic syndrome patients(22 in each group) will receive same low calorie diet and one of the groups plus restricted dietary AGEs according to the international references.Along 8 weeks the investigators will talk to each patient by phone and every months the participants will come and the investigators will take anthropocentric measurements and the recommendations for diets will review. The three-day 24-hour recall food questionnaire will take at first,middle and the end of program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGEs restricted diet | Experimental | Other: AGEs restricted dietLow calorie diet + AGEs restricted diet |
| control | No intervention | –Low calorie diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 years of age
- having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
Key exclusion criteria (5 listed)
- history of allergy
- clinically diagnosed renal, pituitary, thyroid, infections and inflammations, cancer and using of insulin, using multivitamin mineral and vitamin B6 suplements.
- Using any
- history of cancers.
- pregnancy, lactation.
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 |
|---|---|---|
| AGEs restricted dietDiet modification to reduce advanced glycation end products in diet. for example to change ways of cooking, time of cooking and also omit some foods. | Other | AGEs restricted diet |
Primary outcome
Serum Levels of carboxymethyl-lysine(CML)
Time frame: 8 weeks
specific serum AGEs
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 20 Sep 2017.
- 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.
National Nutrition and Food Technology Research Institute study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGEs restricted diet in people with Metabolic Syndrome, run by Dr Azita Hekmatdoost at 1 site in Iran.
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 2 inclusion and 5 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 20 Sep 2017. 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 Iran. 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?
Serum Levels of carboxymethyl-lysine(CML) (time frame: 8 weeks). 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 20 Sep 2017.