The effect of capsule contain cumin essential oil on weight and metabolic profiles of obese and overweight patients and its comparison with orlistat

The aim of this study is to determine the effects of cumin capsules and orlistat on weight changes and metabolic profiles in patients with overweight and obese.

Randomized double-blind placebo-controlled trial.

Among patients with overweight referred to the Naghavi Clinic affiliated to Kashan Medical Sciences University, Kashan, Iran, 87 patients will be selected. The study will be double blind in which participants and investigators/the assessors of the outcomes are unaware of the study groups and drug and placebo are similar. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. Intervention period: 8 weeks.

Inclusion criteria: Overweight (Body mass index range: 25.2–48.8 kg/m 2) and subjects aged 18–60. Exclusion criteria: Those with malignancy, metabolic, thyroid or cardiovascular disorders, pregnancy and lactation, and those using hormonal, antidiabetic, or anti-obesity medications.

Intervention group 1: Cumin essential oil capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks. Intervention group 2: Orlistat capsule (Hoffmann-La Roche Co, Munich, Germany), orally, three times a day, for 8 weeks. Control group: Placebo capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks.

Weight change

Due to an error, the request for an update in our website has been conducted after paper published. However, the revisions were in accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.

Barij Research Center of Medicinal Herbs

Patients will be randomly assigned into three groups. A list of random numbers from 1 to 87 using a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) will be generated, and then patients will be randomly assigned using numbers into three groups. At study baseline, after stratification for gender, pre-intervention body mass index and age, subjects were randomly assigned to three groups. Randomization will be done by the use of computer-generated random numbers.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Placebo capsules contained microcrystalline cellulose and were packed in identical capsules with drugs, and coded by Barij Essence Pharmaceutical company to guarantee blinding. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups.