Effect of a 4-week Alternate Day Intermittent Energy Restriction Intervention vs Reduced
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This pilot study is an active control randomized controlled trial with a sample size of 30
      that will consist of 2 groups, to evaluate the effects of a one-month alternate day
      intermittent energy restriction (AltER) intervention on body weight, body composition,
      resting metabolic rate in college students with obesity as compared to a standard reduced
      calorie diet (RCD). Among the 30 participants, 15 will be randomized into the experimental
      group that will receive the AltER intervention while the other 15 will be a part of the
      active control group that will follow a RCD. The study will be conducted at the Texas Tech
      University Nutrition and Metabolic Health Initiative.
    

Detailed description: 
      This pilot study proposes to investigate the scope and benefits of a novel, hybrid alternate
      day fasting protocol tailored to the college student lifestyle. This protocol - Alternate Day
      Intermittent Energy Restriction (AltER) is novel because it proposes to modify the standard
      ADF regime by increasing energy intake to 40% of calorie needs on fasting days. While this
      may not be as restrictive as other protocols, it still can help create a significant energy
      deficit. Additionally, it will provide flexibility by allowing for two consecutive fast days
      if the individual chooses to. While most dietary interventions can achieve significant weight
      loss in this short duration we expect that this approach tailored to college lifestyle will
      be superior to typical dietary restriction.

      Subjects will be asked to attend two approximately 90-minute assessment visits (4 weeks
      apart) at the NMHI facility They will have their height weight and blood pressure measured,
      fill out questionnaires (attached), and have body composition (BodPod) and resting metabolic
      rate (Metabolic Cart) measured.

      At completion of visit one they are randomly assigned to one of two Diet protocols designed
      to reduce calories and help them to safely lose weight They will also be asked to respond to
      a brief (3 questions) email survey weekly.

      The AltER diet alternate between full calorie (no restriction) eating days with eating 40% of
      your daily caloric requirement on the other day. There will be occasional exceptions allowed
      with maximum of two 40% days in a row (followed by two full days) based on personal schedule
      with prior PI approval. The RCD will require a reduction of 500-1000 calories below daily
      energy requirement. The intervention or control diet will be followed for a duration of 4
      weeks at the end of which the participants will come in for visit 2 which will follow a
      similar format like visit 1.

      General Aim

      To determine the effect of a novel, alternate day intermittent calorie restriction
      intervention on body weight, fat mass and resting metabolic rate of college students with
      obesity as compared to a standard reduced calorie diet 3.2.1. Specific Aim 1: To determine
      the effect of a novel, alternate day intermittent calorie restriction intervention on body
      weight of college students with obesity as compared to a standard reduced calorie diet.

      3.2.1. Specific Aim 2: To determine the effect of a novel, alternate day intermittent calorie
      restriction intervention on fat mass of college students with obesity as compared to a
      standard reduced calorie diet.

      3.2.2. Specific Aim 3: To determine the effect of a novel, alternate day intermittent calorie
      restriction intervention on resting metabolic rate of college students with obesity as
      compared to a standard reduced calorie diet.

      3.2.2. Specific Aim 4: To explore the relationships of stress, sleep physical activity and
      weight history/demographic variables in relation to primary outcomes of interest.
    

Intervention name(s): Alternate Day Intermittent Energy Restriction; Reduced Calorie Diet
Intervention type(s): Other; Other
Intervention description(s): It is a dietary intervention designed to alternate between full energy consumption on one day and 40% of daily energy requirement on the following day.; It is a dietary intervention designed to reduce daily calorie intake by 500-1000 kcal below an individual's daily calorie needs.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 participants will be randomized into 1 of 2 groups 1) n=15 the experimental group that will receive the alternate day intermittent energy restriction intervention and 2 n=15 will be active control group that will follow a standard reduced calorie diet.
Masking: None (Open Label)
Primary purpose: Treatment