Clinical trial NCT04257123: SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY)
Official title: SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Gelesis, Inc.
First posted: 2020-02-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-60 years (this is to reduce the number of people who apply that are taking medications or have chronic diseases).
* BMI =25-40 kg/m2

Exclusion Criteria:

* Body weight fluctuation of \>5kg in the past 3 months
* Participant is allergic to or objects to consuming CMC, Citric acid, Sodium stearyl fumarate, titanium oxide, or gelatin.
* Participants with esophageal anatomic anomalies including webs, diverticuli, and rings
* Participants with suspected strictures (such as patients with Crohn's disease)
* Participants with complications from prior gastrointestinal surgery that could affect GI transit and motility
* Participants with active gastrointestinal conditions such as gastro-esophageal reflux disease (GERD), ulcers, or heartburn
* Participants taking prescribed medications

Primary outcomes:
measure: Appetite Ratings
timeFrame: up to 2 weeks
measure: Eating Behavior
timeFrame: up to 2 weeks
measure: Dietary Assessment
timeFrame: up to 2 weeks
measure: Fecal energy and macronutrient compostion
timeFrame: With initiation of each Controlled-Feeding period, participants will swallow a capsule containing a red dye. They will monitor bowel movements until the red dye is passed. All stool will be collected from this point forward.
Secondary outcomes:
measure: Weight
timeFrame: up to 8 weeks
measure: Compliance
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue Univeristy
state: Indiana
Study officials:
References: