Table 1.

Inclusion and Exclusion Criteria

Inclusion criteria

Subjects should understand the risks and benefits of the protocol

Adults aged 21–50 years

BMI between 30 and 40 kg/m2

Willingness to participate in the exercise-walking program, supervised by a trained exercise specialist

Willingness to consume the prescribed study diet of ∼2000 kcal/day as outlined in the protocol (meals provided free of cost by the study sponsor)

Written informed consent to participate in the trial

Willingness to complete standard health history questionnaire before recruitment into the study

Willingness to participate in five clinical visits (screening, baseline, 2, 4 and 8 weeks)

Subjects should abstain from alcoholic products during the study

If female: should be negative in pregnancy test if of child-bearing potential, and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device, etc.

Exclusion criteria

History of thyroid disease, cardiovascular disease, or diabetes

History of allergy to spices and herbal products

Body weight with BMI>40

Nonobese (BMI<30)

Using other weight loss medications, as well as stimulants, laxatives, or diuretics taken solely for the purpose of weight loss

Recent unexplained weight loss or gain

Positive HIV test

Undergone surgery before 30 days of screening or planning to undergo surgery within the study period

History of hepatitis, pancreatitis, lactic acidosis, or hepatomegaly with steatosis

History of motor weakness or peripheral sensory neuropathy

Any evidence of organ dysfunction or any clinically significant deviation from normal that could impact subjects' well-being or clinical outcome

BMI, body mass index.