SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY)
Condition: Appetitive Behavior
Study type: Interventional

Summary: 
      A recent clinical trial demonstrated the efficacy of Gelesis100 use for weight loss (Obes
      2019;27:205-216). The present trial is designed to explore the mechanisms by which it may
      work, i.e. by suppressing hunger, altering food intake and/or altering the efficiency of
      energy extraction from food.
    

Detailed description: 
      Overweight/obesity is prevalent and associated with multiple adverse health outcomes.
      Moderating energy intake is one approach to lose or maintain body weight. To improve the
      probability of long-term adherence to an energy restricted diet, it is important to address
      the issue of appetite control. Numerous food components and properties have been explored for
      their satiation/satiety value. Two physical properties known to impact appetite are viscosity
      and elasticity (properties common to many dietary fibers). These properties may work by
      multiple mechanisms including prolonged gastric distention after a meal and slowed gastric
      emptying resulting in moderated swings in blood glucose and insulin concentrations. These
      properties may also alter the efficiency of energy absorption.

      The present trial will test the effects of Gelesis100, a FDA cleared superabsorbent hydrogel,
      on the mechanisms just noted. Gelesis100 is nonsystemic and works directly in the
      gastrointestinal tract. Gelesis100 is made from two natural ingredients, cellulose and citric
      acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small
      intestine, to create a sensation of fullness. The capsules disintegrate in the stomach and
      release the Gelesis100 particles, which can hydrate up to 100 times their original weight.
      When fully hydrated, the Gelesis100 particles occupy about a quarter of average stomach
      volume (although this may vary based on body size and various other factors). Without
      increasing the caloric value of a meal, Gelesis100 particles mix with ingested foods and
      create thousands of small, nonclustering individual gel pieces. The gel particles mix with
      ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach
      and small intestine, promoting satiety and fullness. Gelesis100 has been cleared by FDA
      through the 510k de novo process and is marketed as a prescription medical device for weight
      management under the trade name Plenity™. A recent clinical trial demonstrated the efficacy
      of its use for weight loss (Obes 2019;27:205-216). The present trial is designed to explore
      the mechanisms by which it may work, i.e. by suppressing hunger, altering food intake and/or
      altering the efficiency of energy extraction from food.
    

Intervention name(s): Gelesis100; Placebo
Intervention type(s): Device; Other
Intervention description(s): Participants will administer Gelesis100 before lunch and dinner meals.; Participants will administer a placebo before lunch and dinner meals.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Following an initial 3-day run-in period (feeding only), participants will be randomly assigned to two 1-week controlled feeding periods with and without Gelesis100. After a one week washout, participants will complete the other pattern. Following another 1-week washout, participants will be randomly assigned again to two 1-week free-feeding periods with and without Gelesis100. After a one week washout, participants will complete the other pattern.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science