Blocking carbohydrate absorption and weight loss: a clinical trial using the phase 2® brand proprietary fractionated white bean extract

INTERVENTION: After this screening period, participants were randomly allocated to receive either the Phase 2® brand proprietary fractionated white bean extract or identical placebo in a double‐blind manner. Assessors and participants were blinded to group assignment. Two people dropped out after having been randomised. One withdrew from the study before receiving any product and another withdrew after receiving product but without ingesting it or following other protocol requirements. These persons are not included in the data analysis. Phase 2® was administered in the form of a 500 mg capsule. A capsule of identical appearance, texture, taste, and smell was used as the placebo. Participants were advised to take two capsules (1000 mg) at the beginning of breakfast and lunch each day. No other drugs, herbs, or non‐prescription products for obesity were allowed during the study. An intensive dietary intervention including personalised diet instructions and prepared food was provided. Participants in both groups were supplied with supplemental foods which met the diet parameters to facilitate compliance and to avoid having diet restrictions produce a financial burden for participants. Breakfast and lunch were provided on a daily basis and dinners were prepared along dietary guidelines by participants. They were instructed to maintain a caloric intake of 1800 calories. Additionally, they also received a personalised exercise regimen which instructed them to exercise at least one half hour, four times a week. Finally, subjects received weekly group behavioral therapy sessions in order to problem‐solve personal eating issues. CONDITION: Overweight ; Nutritional, Metabolic, Endocrine ; Obesity PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Aged over 18 and under 40 at screening 2. Body Mass Index (BMI) more than or equal to 23kg/m^2 and less than 31 kg/m^2 at screening 3. Agreement to maintain diet, exercise and behavioral modification guidelines while participating in the study 4. Agreement to periodic follow‐up 5. Females agreement to use appropriate birth control methods during the active study