search
Back to results

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

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
nanomicielle curcumin
placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Golbon SohrabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

nanomicielle curcumin

plecebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2018
Last Updated
July 29, 2018
Sponsor
National Nutrition and Food Technology Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03534024
Brief Title
The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome
Official Title
The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2018 (Anticipated)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nanomicielle curcumin
Arm Type
Active Comparator
Arm Title
plecebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
nanomicielle curcumin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
hemoglobin A1c (HbA1c)
Time Frame
12 weeks
Title
serum glucose
Time Frame
12weeks
Title
serum insulin
Time Frame
12weeks
Title
homeostatic model assessment of insulin resistance(HOMA-IR)
Time Frame
12weeks
Title
homeostatic model assessment of beta cell(HOMA-B)
Time Frame
12weeks
Title
serum triglyceride (TG)
Time Frame
12 weeks
Title
serum total Cholesterol
Time Frame
12 weeks
Title
serum LDL-C
Time Frame
12 weeks
Title
serum HDL-C
Time Frame
12 weeks
Title
systolic blood pressure
Time Frame
12 weeks
Title
diastolic blood pressure
Time Frame
12 weeks
Title
serum curcumin
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Golbon Sohrab
City
Tehran
State/Province
National Nutrition And Food Technology Research Institute
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Golbon Sohrab, ph.D
Phone
009802122077424
Email
golbonsohrab@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zohre Bateni
Phone
009809129626018
Email
zohre.bateni@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs