Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects

NCT01894295 | Unknown

• 1 other identifier: 91-03-27-18831
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the resting metabolic rate. Moreover, the investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α) protein which may lead to change in metabic rate following treatment with either alphacalcidol or placebo.

Conditions

Obesity

Keywords

Vitamin D analogues; Resting Metabolic rate; obesity

Outcome Measures

Primary Outcomes (1)

• Resting Metabolic Rate

  Measurement by indirect calorimetry.

  Change from baseline to 8 weeks

Secondary Outcomes (1)

• Changes of Nesfatin-1, PPARγ and PGC1α protein levels

  Change from baseline to 8 weeks

Other Outcomes (1)

• Change of ACS and FASN Enzymes

  Change from baseline to 8 weeks

Study Arms (2)

Vitamin D analogue

EXPERIMENTAL

1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram.

Dietary Supplement: Vitamin D analogue

Placebo

PLACEBO COMPARATOR

Corn oil pearl Capsules 1 gram

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks

Also known as: corn oil capsule

Placebo

Vitamin D analogue DIETARY_SUPPLEMENT

1-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks

Also known as: 1-α hydroxyvitamin D3

Vitamin D analogue

Eligibility Criteria

• Age: 22 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 22-52 years Body mass index equal or more than 30

You may not qualify if:

• Acute or chronic inflammatory disease History of hypertension Alcohol or drug abuse History of any condition affecting inflammatory markers Thyroid diseases Malignancies Current smoking Diabetes mellitus Sustained hypertension Heart failure Acute or chronic infections Hepatic or renal diseases Use of PPARγ agonist drug

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

TehranUMS

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mahmoud Jalali, PhD

  Tehran University of Medical Sciences

  STUDY DIRECTOR

• Khadijeh Mirzaei, MS

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Jalali, Phd

CONTACT

+982188954911; jalalimahmoud@hotmail.com

Khadijeh Mirzaei, MS

CONTACT

+989124379670; mina_mirzaei101@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

IR (1)