Appetitive BehaviorNCT04257123
SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY)
A study testing Gelesis100 in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Gelesis100
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Appetitive Behavior
- Being tested
- Gelesis100, Placebo
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelesis100Device
Participants will administer Gelesis100 before lunch and dinner meals.
PlaceboOther
Participants will administer a placebo before lunch and dinner meals.
| Study group | Role | What they receive |
|---|---|---|
| Controlled-Feeding | Experimental | For two weeks (separated by a wash-out week), participants will consume all meals in the Nutrition Science facility. Receives: 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. Receives: Device: Gelesis100; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Body weight will be measured
Measured: up to 8 weeks
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.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Jan 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Gelesis, Inc.
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257123
- Sponsor's protocol ID
- 055-051
- Status last verified
- Apr 2022
- First submitted
- 28 Jan 2020
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY)
- ClinicalTrials.gov ID
- NCT04257123
- Acronym / sponsor ID
- 055-051
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Gelesis, Inc.
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Controlled-Feeding | Experimental | Device: Gelesis100, Other: PlaceboFor two weeks (separated by a wash-out week), participants will consume all meals in the Nutrition Science facility. |
| Free-Feeding | Experimental | Device: Gelesis100, Other: PlaceboFor two weeks (separated by a wash-out week), participants will receive no dietary guidance and will be allowed to consume whatever they desire. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelesis100Participants will administer Gelesis100 before lunch and dinner meals. | Device | Controlled-Feeding, Free-Feeding |
| PlaceboParticipants will administer a placebo before lunch and dinner meals. | Other | Controlled-Feeding, Free-Feeding |
Primary outcome
Appetite Ratings
Time frame: up to 2 weeks
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.
Eating Behavior
Time frame: up to 2 weeks
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.
Dietary Assessment
Time frame: up to 2 weeks
Diet composition during the free-feeding periods will be assessed by diet histories taken by a registered dietitian through the Nutrition Assessment Center.
Fecal energy and macronutrient compostion
Time frame: 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.
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.
2 secondary outcomes
Weight
Time frame: up to 8 weeks
Compliance
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelesis100 in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite Ratings (time frame: up to 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.