NCT03514667

Brief Summary

Metabolic syndrome is a public health challenge that includes a range of conditions including abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. The syndrome is associated with an increase in the risk of Cardiovascular disease and death. Curcumin is a very active compound obtained from turmeric root. Curcumin has antioxidant and anti-inflammatory effects, and is also involved in the regulation of several signaling pathways. Since curcumin powder has low bioavailability, fast metabolism and low absorption, nanomicielle curcumin will be used in this study. Therefore, this study is planned to determine the effects of supplementation of nanomicielle curcumin on oxidative stress, systemic inflammation, adiponectin in serum and NF-kB in peripheral blood mononuclear cells in patients with metabolic syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

April 20, 2018

Last Update Submit

July 29, 2018

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (6)

  • Serum Total antioxidant capacity (TAC)

    12 weeks

  • Serum Malondialdehyde (MDA)

    12weeks

  • Serum C-reactive protein (CRP)

    12weeks

  • Serum Adiponectin

    12weeks

  • NF-kB(p65) transcription in PBMC

    12weeks

  • Serum curcumin

    12 weeks

Study Arms (2)

intervention group

ACTIVE COMPARATOR

80 mg nanomicielle curcumin capsules once a day for 12 weeks

Dietary Supplement: nanomicielle curcumin

control group

PLACEBO COMPARATOR

placebo capsules once a day for 12 weeks

Dietary Supplement: placebo

Interventions

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 nanomicielle curcumin or placebo. nanomicielle 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 group
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 nanomicielle curcumin or placebo. nanomicielle 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.

control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golbon Sohrab

Tehran, National Nutrition and Food Technology Research Institute, Iran

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 2, 2018

Study Start

August 30, 2018

Primary Completion

August 30, 2019

Study Completion

January 30, 2020

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

IR(1)