Metabolic SyndromeNCT03534024
The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome
A study testing nanomicielle curcumin in people with Metabolic Syndrome, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- nanomicielle curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 30 Aug 2018to 30 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25<body mass index >40
- waist circumference >102 cm in men or >88 cm in women
- Fasting blood glucose >100 mg/dL
- Triglycerides (TG) > 150 mg/dL
- High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men
- Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg
Who cannot join
- insulin administration for diabetes control
- hypo- or hyperthyroidism,
- renal failure or other chronic diseases
- pregnancy and breastfeeding
- taking weight loss supplements and obeying unusual weight loss plans
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Golbon Sohrab
Tehran, National Nutrition and Food Technology Research Institute
Golbon Sohrab, ph.D, 009802122077424, golbonsohrab@yahoo.com
Zohre Bateni, 009809129626018, zohre.bateni@yahoo.com
About this study
Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and anti-inflammatory effects. nanomcielle curcumin will be used in this study because of the low bioavailability , fast metabolism and low absorption of curcumin powder. Therefore, this study is planned to determine the effects of supplementation of nanomicelle curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- nanomicielle curcumin, placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanomicielle curcuminDietary supplement
Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicelle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.
placeboDietary supplement
Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomcielle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.
| Study group | Role | What they receive |
|---|---|---|
| nanomicielle curcumin | Active comparator | Not described Receives: Dietary Supplement: nanomicielle curcumin |
| plecebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c (HbA1c)
Measured: 12 weeks
serum glucose
Measured: 12weeks
serum insulin
Measured: 12weeks
homeostatic model assessment of insulin resistance(HOMA-IR)
Measured: 12weeks
homeostatic model assessment of beta cell(HOMA-B)
Measured: 12weeks
serum triglyceride (TG)
Measured: 12 weeks
serum total Cholesterol
Measured: 12 weeks
serum LDL-C
Measured: 12 weeks
serum HDL-C
Measured: 12 weeks
systolic blood pressure
Measured: 12 weeks
diastolic blood pressure
Measured: 12 weeks
serum curcumin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start30 Aug 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Jan 2020 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
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
- NCT03534024
- Sponsor's protocol ID
- 207
- Status last verified
- Jul 2018
- First submitted
- 11 May 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03534024
- Acronym / sponsor ID
- 207
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 30 Aug 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 23 May 2018 (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.
Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and anti-inflammatory effects. nanomcielle curcumin will be used in this study because of the low bioavailability , fast metabolism and low absorption of curcumin powder. Therefore, this study is planned to determine the effects of supplementation of nanomicelle curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in patients with metabolic syndrome.
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 |
|---|---|---|
| nanomicielle curcumin | Active comparator | Dietary Supplement: nanomicielle curcumin |
| plecebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 25<body mass index >40
- waist circumference >102 cm in men or >88 cm in women
- Fasting blood glucose >100 mg/dL
- Triglycerides (TG) > 150 mg/dL
- High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men
Key exclusion criteria (5 listed)
- insulin administration for diabetes control
- hypo- or hyperthyroidism,
- renal failure or other chronic diseases
- pregnancy and breastfeeding
- taking weight loss supplements and obeying unusual weight loss plans
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 |
|---|---|---|
| nanomicielle curcuminParticipants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicelle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study. | Dietary supplement | nanomicielle curcumin |
| placeboParticipants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomcielle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study. | Dietary supplement | plecebo |
Primary outcome
hemoglobin A1c (HbA1c)
Time frame: 12 weeks
serum glucose
Time frame: 12weeks
serum insulin
Time frame: 12weeks
homeostatic model assessment of insulin resistance(HOMA-IR)
Time frame: 12weeks
homeostatic model assessment of beta cell(HOMA-B)
Time frame: 12weeks
serum triglyceride (TG)
Time frame: 12 weeks
serum total Cholesterol
Time frame: 12 weeks
serum LDL-C
Time frame: 12 weeks
serum HDL-C
Time frame: 12 weeks
systolic blood pressure
Time frame: 12 weeks
diastolic blood pressure
Time frame: 12 weeks
serum curcumin
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nanomicielle curcumin in people with Metabolic Syndrome, run by National Nutrition and Food Technology Institute 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 6 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: status not confirmed, as of the sponsor's last update on 31 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin A1c (HbA1c) (time frame: 12 weeks). The study lists 12 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 31 Jul 2018.