SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY)

Appetitive Behavior Clinical Trial

Official title:

SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257123
• Other study ID #: 055-051
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior

Intervention

Device:
• Gelesis100
Participants will administer Gelesis100 before lunch and dinner meals.

Other:
• Placebo
Participants will administer a placebo before lunch and dinner meals.

Locations

Country	Name	City	State
United States	Purdue Univeristy	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Gelesis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appetite Ratings	Hunger, fullness, desire to eat and thirst will be measured on visual analogue scales with end anchors of "not at all" to "extremely." Ratings will be captured via Qualtrics software. Also, subjects will be asked to indicate when, during the meals, they feel full on the first and last days of the Controlled-Feeding periods.	up to 2 weeks
Primary	Eating Behavior	A battery of validated questionnaires related to Ingestive behavior will be completed. These include Power of Food Scale, Emotional Eating Scale, Three-Factor Eating Questionnaire-Revised, Food Craving Inventory-II, Barratt Impulsiveness Scale, Adult Eating Behavior Scale, Self-Regulation of Eating Behavior Questionnaire for Adults, Meal Pattern Questionnaire, Study-Specific Appetite and Eating Behavior Questionnaire.	up to 2 weeks
Primary	Dietary Assessment	Diet composition during the free-feeding periods will be assessed by diet histories taken by a registered dietitian through the Nutrition Assessment Center.	up to 2 weeks
Primary	Fecal energy and macronutrient compostion	A quantitative stool collection method will be used. Collections will be homogenized and aliquots will be freeze-dried. Energy and macronutrient composition analysis of feces will be conducted in triplicate.	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	Weight	Body weight will be measured	up to 8 weeks
Secondary	Compliance	Eighty milligrams of PABA will be taken in capsule form with the pre-lunch and pre-dinner beverage to serve as a compliance biomarker during the Free-Feeding periods. 24-hour urine samples will be collected in 3 L opaque collection bottles. Urinary PABA recovery will be analyzed using spectrophometric methods. Completeness of PABA collection will calculated as the measure of compliance ( ). Compliance will also be assessed by counting capsules returned by the subjects.	up to 2 weeks