Impact of Protein Quantity Within the USDA Healthy Style Eating Pattern on Sleep
Condition: Sleep; Body Composition
Study type: Interventional

Summary: 
      This evaluates the affect of protein quantity on indices of sleep. Half the participants will
      be prescribed protein in the amount consistent with the USDA healthy style eating pattern,
      while the other half will be prescribed a diet containing 12.5 oz eq of protein.
    

Detailed description: 
      According to the National Sleep Foundation, 13% of U.S. adults were reported to sleep 6 hours
      or less per weeknight in 2001. Eight years later, the number increased to 20%. Also, the
      proportion of people experiencing a sleep problem (e.g. difficulties in initiating or
      maintaining sleep) several nights per week has increased dramatically (from 51% to 64% in
      2001 to 2009). Getting enough and good quality sleep is essential to health. Indices of
      sleep, including duration, quality, and patterning are related to obesity, type 2 diabetes,
      cardiovascular disease, hypertension, worsen lipid-lipoprotein status, and premature death.
      All of these morbidities and mortality are also impacted by diet .

      The 2015 Dietary Guidelines Advisory Committee recognized "an insufficient body of evidence"
      in the "emerging area" of "associations between sleep patterns, dietary intakes, and obesity
      risk" and that "a paucity of research exists on the potential impact of diet on sleep-related
      outcomes". Currently the majority of research has assessed the influence of sleep on energy
      balance or dietary choices. The reversed relation, how diet influence sleep, received much
      less attention. In general, diet-induced weight loss is considered to improve sleep quality
      and increase sleep duration. However, emerging research brings into question the impact of
      the macronutrient distribution during dietary energy restriction (ER) on indices of sleep.
      Dietary protein, due to its ability to provide tryptophan and tyrosine (precursors of
      neurotransmitters melatonin and dopamine), may influence sleep. Despite the fact that both
      diet and sleep predict obesity and chronic diseases, limited research exists on the effects
      of dietary energy and macronutrients, especially high-quality protein intake, on indices of
      sleep.

      The primary aim is to assess the effects of the USDA Healthy U.S.-Style Eating Pattern with
      higher amounts of animal-based protein-rich foods (lean meats and eggs) on health outcomes
      including sleep and blood pressure.

      This is a 16-week randomized, parallel, placebo-controlled, single-blind study. During
      baseline, participant's diet, general health, and sleep quality will be assessed.
      Participants will then be randomized and assigned to either the normal protein or high
      protein (5 vs. 12.5 oz-eq of protein foods daily) for the 12-week weight loss intervention
      with the energy-restriction (750 kcal/day dietary energy deficits).
    

Intervention name(s): Normal protein; High protien
Intervention type(s): Other; Other
Intervention description(s): Following a two week baseline assessment period, subjects will consume a diet with normal protein diet while undergoing weight loss for 12 wk.; Following a two week baseline assessment period, subjects will consume a diet with high protein diet while undergoing weight loss for 12 wk.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science