TRE With Physical Activity for Weight Management
Condition: Pre Diabetes; Overweight and Obesity
MeSH terms: Overweight; Prediabetic State
Study type: Interventional

Summary: 
      Approximately 24 million older adults have prediabetes. Obesity, age related decreases in
      lean mass and increases in fat mass, and sedentary lifestyle have been associated with
      functional and cognitive decline in older adults. Innovative lifestyle strategies to treat
      obesity and pre-diabetes are critically needed. The proposed research will demonstrate that
      time restricted eating combined with resistance training is an effective non-pharmacological
      therapy to help obese prediabetic individuals reduce body fat, maintain lean mass, prevent
      progression of prediabetes to diabetes, and improve cognition.
    

Detailed description: 
      Obesity, age related decreases in lean mass and increases in fat mass, and sedentary
      lifestyle have been associated with functional and cognitive decline in older adults. It is
      expected that the proportion of the population of over 65 will continue to increase as will
      the number of older adults with pre-diabetes. Treatment of pre-diabetes and improved
      functionality and cognition in older adults include maintaining a healthy weight and regular
      exercise. While daily calorie restriction is the most common prescription for weight loss,
      intermittent fasting is an alternative to daily calorie restriction producing significant
      weight loss. Currently, the most popular form of intermittent fasting is time restricted
      eating (TRE). TRE typically involves confining the eating window to 6-10 h and fasting for
      the remaining hours of the day. During the eating window, individuals are not required to
      count calories or monitor food intake in any way. Current TRE data shows promising results
      for diet alone including natural calorie restriction, weight loss, decreased blood pressure
      and increased insulin sensitivity all while maintaining a high adherence. To our knowledge,
      TRE combined with resistance training (RT) or endurance training (EN)has only been examined
      in lean resistance trained young adults, never in older adults or adults with overweight or
      obesity. Hypothesis: The present proposal will test the following hypothesis: (1) Both
      combination groups will lose significantly more weight than TRE alone or the control. The TRE
      + RT group will significantly decrease fat mass and increase lean mass more than the TRE +
      EN, TRE alone or control group. The TRE + RT will lose the same amount of body weight but
      maintain more lean mass than the TRE+EN group; (2a) The TRE+RT group will experience greater
      improvements in insulin sensitivity, insulin resistance, HbA1c and other metabolic disease
      variables (fasting insulin, triglycerides, LDL cholesterol, and blood pressure) versus the
      TRE+EN group after the 8-week trial due to reductions in body weight and greater retention of
      lean mass; (2b) TRE combined with both EN and RT will be safe in older adults with no
      significant intervention related adverse events; (3) TRE combined with both EN and RT will
      improve attention and executive function and working memory in the physical activity groups
      more than diet alone or the control group. Methods: To test these objectives, a 10-week
      parallel-arm pilot trial will be implemented. Older adults with overweight or obesity and
      pre-diabetes will be assigned to one of four groups: (1) TRE group, ad-libitum eating between
      12:00-20:00 (n=50) (2) TRE + EN ad-libitum eating between 12:00-20:00 with 3-5 days of
      supervised endurance exercise per week (n=50) (3)TRE + RT group, ad-libitum eating between
      12:00-20:00 with 3-5 days of supervised resistance training per week (n=50) or (4) Control
      group, no change in diet or physical activity (n=50). Significance: If the aims of this
      application are achieved, this study will be the first to show that TRE with physical
      activity is safe in older adults and can be implemented as an alternative to traditional
      dieting (i.e. daily calorie restriction) for weight management and lean mass retention. This
      study will also show that TRE can be used as an effective non-pharmacological therapy to
      improve insulin sensitivity, decrease metabolic risk factors, and improve cognition in older
      individuals with obesity and pre-diabetes.
    

Intervention name(s): Time restricted eating
Intervention type(s): Behavioral
Intervention description(s): We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
Other intervention name(s): resistance training; endurance exercise
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intermittent Fasting