Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Intermittent Fasting and Caloric Restriction on Total and Regional Body Composition, Cardiometabolic, Oxidative Stress & Plasma Toxin Biomarkers, and Energy Metabolism in Overweight/Obese Men and Women
Brief Summary: This study systematically quantified the effects of intermittent fasting and caloric restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were enrolled in the study as a single cohort and participated in an 12-week trial consisting of two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2) 11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to maintain their body weight by consuming their normal food intake; however, during the 11 week IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of body weight loss per week. At the conclusion of the 12 week weight loss study, all 40 participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they agreed to participate, groups were balanced so there were similar numbers of men and women and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a modified version of the 12 week weight loss intervention that consumes whole foods along with 2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n= 18) and asked to follow these nutritional guidelines ad libitum for the duration of 12 months.


Options:
A: Arm Label: Skipping Breakfast (NoB); Type: EXPERIMENTAL; Interventions: Other: Skipping Breakfast | Arm Label: Eating Breakfast (YesB):; Type: ACTIVE_COMPARATOR; Interventions: Other: Eating Breakfast | Intervention Type: OTHER; Name: Skipping Breakfast; Assigned to Arm(s): Skipping Breakfast (NoB) | Intervention Type: OTHER; Name: Eating Breakfast; Assigned to Arm(s): Eating Breakfast (YesB):
B: Arm Label: Weight Loss Phase; Type: EXPERIMENTAL; Interventions: Behavioral: Weight Loss Phase | Arm Label: Weight Loss Maintenance Phase; Type: EXPERIMENTAL; Interventions: Behavioral: HP-IF, Behavioral: HH | Intervention Type: BEHAVIORAL; Name: Weight Loss Phase; Assigned to Arm(s): Weight Loss Phase | Intervention Type: BEHAVIORAL; Name: HP-IF; Assigned to Arm(s): Weight Loss Maintenance Phase | Intervention Type: BEHAVIORAL; Name: HH; Assigned to Arm(s): Weight Loss Maintenance Phase
C: Arm Label: Control group; Type: OTHER; Interventions: Other: control group | Arm Label: Intermittent Fasting group; Type: EXPERIMENTAL; Interventions: Other: Intermittent Fasting group | Intervention Type: OTHER; Name: Intermittent Fasting group; Assigned to Arm(s): Intermittent Fasting group | Intervention Type: OTHER; Name: control group; Assigned to Arm(s): Control group
D: Arm Label: Time-Restricted Feeding (early in the day eating); Type: EXPERIMENTAL; Interventions: Other: Time-Restricted Feeding | Arm Label: Grazing; Type: PLACEBO_COMPARATOR; Interventions: Other: Grazing | Intervention Type: OTHER; Name: Time-Restricted Feeding; Assigned to Arm(s): Time-Restricted Feeding (early in the day eating) | Intervention Type: OTHER; Name: Grazing; Assigned to Arm(s): Grazing

Answer: B