Evaluation of olive leaf extract on weight and body composition, free fatty acid, glycemic factors, lipid profile and serum level of adipocytokines in obese women on a weight-loss diet

Determine the effect of olive leaf extract on weight and body composition, free fatty acid, glycemic factors, lipid profile and serum level of adipocytokines in obese women on a weight-loss diet

This is a double-blind, parallel-group, randomized controlled clinical trial

This study will be carried out by referring to private nutrition office in Ahvaz city. Individuals in the intervention and control group will receive 250 mg of olive leaf extract daily in the form of pills or placebo for 2 months, respectively. Each person will fill the individual consent, physical activity and food record questionnaires. At the beginning and the end of the study, fasting blood samples are taken from 5 mL blood donors. energy needs will calculate by Mifflin Jeor St equation. Then, 500 kcal of estimated energy requirements will deduct.

Eligibility criteria: women aged 18 to 50 years old and body mass index (BMI) between 30 to 40; Non eligibility criteria: menopause, pregnancy and breastfeeding, having history of food allergy, cancer, acute or chronic renal failure, acute or chronic hepatic failure, thyroid disorder and gastrointestinal diseases, having surgical operation for weight loss, having weight loss over the past six months ,consumption of multivitamin/mineral or herbal supplements and weight-loss drugs, did not use of more than 10% of drugs

1) Placebo group plus a standard hypocaloric diet 2) Olive leaf extract supplementation group plus a standard hypo-caloric diet

Weight, body composition, free fatty acid level, glycemic status, lipid profile, leptin, adiponectine

Eligible subjects will be divided randomly into two groups including control and intervention. Randomization will be performed using the computer-generated random numbers. the naming of olive leaf extract or placebo bottles will be done based on random numbers and odd or even numbers will be allocated to the A or B group. To achieve allocation concealment, the bottles will be sealed and we will be assured from the similarity of appearance and their weight. The randomization process will be performed by an individual other than the investigators to reduce the probable bias.

Blinding will be done in the case of participants and the main investigator. For blinding, placebo capsules will be prepared in the same size, shape, bottle with olive leaf extract capsules. Bottles will be encoded A or B. Also, the researcher is unaware of the type of capsules. Therefore, that participants and researcher will be blinded at the selection step and information collection.

Publication of protocol study in form of the article and also data publication in the original article. The total potential data can be shared after unidentifiable subjects.

6 months after the publication of results

All researchers who have access to clinical trials databases

The only way for using the data is after the publication of the article in the indexed ISI journal.

Via database websites such as PubMed and google scholar and via email address: forough_shayesteh@yahoo.com

The original article reaches the request or by email within a maximum of one week.