The effect of biscuit fortified with whey protein and dietary fiber on biochemical and behavioral factors of appetite, anthropometric indices, and glycemic profile in overweight or obese adults

Determine the effect of biscuit fortified with whey protein and dietary fiber on biochemical and behavioral factors of appetite, anthropometric indices, and glycemic profile in overweight or obese adults

In this study, 100 subjects will be selected, who will be overweight or obese, and follow the inclusion criteria. Then they will be allocated to intervention groups, thorough balanced block randomization method.

Participants will be invited to study thorough announcement. Sampling will be done in Imam Reza clinic. Participants will be randomly allocated to a group of intervention or control. Blinding protocol will done to blind participants and researcher from allocation of subjects.

Inclusion criteria: male and female gender; age 20 -50 years old; BMI higher than 25 kg/m2. Non-inclusion criteria: follow weight loss diet during 6 months ago; psychological disorders related to eating disorders; use of multivitamin-mineral supplements and herbal medications; chronic disease and use drugs, which affected the metabolism, body composition and appetite; food allergy; pregnancy and lactation; alcohol and tobacco use.

Participants allocated to 1) intake of biscuit fortified with whey protein and dietary fiber , 2) intake of biscuit fortified with whey protein , 3) intake of biscuit fortified with dietary fiber, or 4) intake of non fortified biscuit as control group. All participants will follow a diet with reduction of 500 kcal of total energy.

Energy intake; appetite score; serum level of ghrelin, leptin, glucagon like peptide, serotonin, fasting blood sugar, insulin, lipid profiles, and weight, waist circumference, waist to height ratio, body mass index, fat mass, mood indices, and quality of life.

Balanced block randomization method will be used to random allocation, and randomization unit will be a subject. At first, we will design blocks with different sequences of A, B, C, and D. Then we will select a block, in a draw. Each block contain a sequence of A, B, C, and D which determine intervention groups. Participants and researchers will not be notified the packages content.

Participants, clinical assessor, and researcher will be blind. Participants, clinical assessor, and researcher don't know subjects allocated to which group. Participants will be identified by A, B, C, and D letters.