The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome

July 29, 2018 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • National Nutrition And Food Technology Research Institute
      • Tehran, National Nutrition And Food Technology Research Institute, Iran, Islamic Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: nanomicielle curcumin
Dietary supplement: nanomicielle curcumin
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.
Placebo Comparator: plecebo
Dietary supplement: placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
systolic blood pressure
Time Frame: 12 weeks
12 weeks
hemoglobin A1c (HbA1c)
Time Frame: 12 weeks
12 weeks
serum glucose
Time Frame: 12weeks
12weeks
serum insulin
Time Frame: 12weeks
12weeks
homeostatic model assessment of insulin resistance(HOMA-IR)
Time Frame: 12weeks
12weeks
homeostatic model assessment of beta cell(HOMA-B)
Time Frame: 12weeks
12weeks
serum triglyceride (TG)
Time Frame: 12 weeks
12 weeks
serum total Cholesterol
Time Frame: 12 weeks
12 weeks
serum LDL-C
Time Frame: 12 weeks
12 weeks
serum HDL-C
Time Frame: 12 weeks
12 weeks
diastolic blood pressure
Time Frame: 12 weeks
12 weeks
serum curcumin
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2018

Primary Completion (Anticipated)

August 30, 2019

Study Completion (Anticipated)

January 30, 2020

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 11, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 29, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 207

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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