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

NCT04257123 | Completed FDA Device

• 1 other identifier: 055-051
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetitive Behavior

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Weight

  up to 8 weeks

• Compliance

  up to 2 weeks

Study Arms (2)

Controlled-Feeding

EXPERIMENTAL

For two weeks (separated by a wash-out week), participants will consume all meals in the Nutrition Science facility.

Device: Gelesis100; Other: Placebo

Free-Feeding

EXPERIMENTAL

For two weeks (separated by a wash-out week), participants will receive no dietary guidance and will be allowed to consume whatever they desire.

Device: Gelesis100; Other: Placebo

Interventions

Gelesis100 DEVICE

Participants will administer Gelesis100 before lunch and dinner meals.

Controlled-Feeding; Free-Feeding

Placebo OTHER

Participants will administer a placebo before lunch and dinner meals.

Controlled-Feeding; Free-Feeding

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• Gelesis, Inc.: collaborator

Study Sites (1)

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Treatment with Gelesis100 or placebo will be double-blinded and randomly assigned.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Nutrition Science

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: January 7, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

US (1)