Weight ManagementNCT07127198
Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties
A study testing Beverage Variant 1 (low gelation properties), Beverage Variant 2 (medium gelation properties) and Beverage Variant 3 (high gelation properties) in people with Weight Management, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The physical properties of a food product, such as its gelling properties in the stomach can influence how full a person may feel after its consumption. Decreasing appetite feeling through consumption of such a product with a low energy content may contribute to weight management. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- Beverage Variant 1 (low gelation properties), Beverage Variant 2 (medium gelation properties) and Beverage Variant 3 (high gelation properties)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 May 2025to 31 Oct 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female aged 18-65 years old (inclusive)
- Body Mass Index (BMI) 27 - 32kg/m2 (inclusive), measured and defined by the site
- Self-reported stable body weight for the past 6 months prior to screening (defined as not having gained or lost more than 5% of body weight)
- Comfortable using technology, such as a smartphone or laptop
- Willing and able to understand and sign a written informed consent prior to study entry
- Deemed able to comply with the requirements of the study protocol and consume study products by study nurse
Who cannot join
- Currently or in the last 3 months, use of medications affecting weight, study outcomes, including fat absorption such as, but not limited to: GLP-1 receptor analogues, SGLT-2 inhibitors, weight loss medications, medications that affect gastric pH, and any of the following drugs: cephaloridine, verapamil, valproic acid, and sulfonylureas, usually acting by competitive inhibition of L-carnitine transport by OCTN2, Orlistat, antacids, proton pump inhibitors, antibiotics, steroids or medications affecting thyroid hormones or gut hormones, antipsychotic medications, or antidepressants. As reported by participant.
- Diagnosed with Eating behaviour disorders such as emotional or restrained eating determined or any ongoing psychiatric illness. As reported by participant.
- Currently or within the last 3 months or planning to during the course of the study being on a weight loss regime (defined by actively following a diet such as Atkins, weight watchers, meal replacements, low or very low carbohydrate diet, ketogenic diet, intermediate fasting or enrolled into a governmental health program) or applying significant restrictions on food intake (i.e., regular breakfast skipping, regular cut on carbohydrates, regular intermittent fasting, diet reducing a specific macronutrient, diet significantly reducing calorie intake, excluding a group of food that was not excluded before). As reported by participant.
- Any known/suspected food allergies. As reported by participant.
- Currently pregnant, lactating, or breastfeeding. As reported by participant.
- Unstable diagnosed chronic conditions (such as hypertension, cardiovascular diseases, liver diseases, renal diseases, metabolic diseases). Unstable is defined as a change in medications in the past 3 months, or a change in disease severity in the past 3 months. As reported by participant.
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- Acute GI upset (such as diarrhoea/constipation in the last 2 weeks, abdominal cramping etc.). As reported by participant.
- Diagnosed with chronic GI disorder such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or irritable bowel syndrome. As reported by participant.
- Ever underwent surgery for weight loss such as bariatric procedures or gastric bypass. As reported by participant.
- Recent blood donation (<8 weeks). As reported by participant.
- Current or past smokers (stopped less than 3 months ago). As reported by participant.
- Any drug abuse within the past year. As reported by participant.
- Alcohol consumption above levels recommended for healthy adults: Average alcohol intake > 2 standard drinks per day over a week for males or > 1 standard drink per day over a week for females as reported by the participant. One standard drink contains 10-12 g of ethanol, i.e., 0.3 dl of strong alcohols, 1dl of wine, 3 dl of beer. As reported by participant.
- Currently participating in another interventional study. As reported by participant.
- Family or hierarchical relationships with the research team members. As reported by participant.
Trial locations and contacts
1 site in 1 country.
About this study
The physical properties of a food product, such as its gelling properties in the stomach can influence how full a person may feel after its consumption. Decreasing appetite feeling through consumption of such a product with a low energy content may contribute to weight management.
The study will assess if a drink with gelation properties in the stomach can reduce appetite and therefore contribute to weight management.
This is a single-center, double-blinded, 4 arm cross-over randomized controlled study looking to enroll 24 adult participants. The study will be performed at the Clinical Innovation Lab (CIL), Nestlé Research, Lausanne. Enrolled participants will have 4 visit days after the screening visit. They will consume one of the test products, or control at each visit and complete the study assessments.
- Conditions
- Weight Management
- Being tested
- Beverage Variant 1 (low gelation properties), Beverage Variant 2 (medium gelation properties), Beverage Variant 3 (high gelation properties), Control group (no gelation property)
- Keywords
- weight, drink
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage Variant 1 (low gelation properties)Dietary supplement
The first interventional product for this study is a drink containing protein and fiber at a concentration 1. It will come in a ready to drink format for the participants.
Beverage Variant 2 (medium gelation properties)Dietary supplement
The first interventional product for this study is a drink containing protein and fiber at a concentration 2. It will come in a ready to drink format for the participants.
Beverage Variant 3 (high gelation properties)Dietary supplement
The first interventional product for this study is a drink containing protein and fiber at a concentration 3. It will come in a ready to drink format for the participants.
Control group (no gelation property)Other
The control product for this study is a drink containing protein and fiber. It will come in a ready to drink format for the participants.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Product 1 | Active comparator | Protein \& Fiber - Variant 1 Receives: Dietary Supplement: Beverage Variant 1 (low gelation properties) |
| Interventional Product 2 | Active comparator | Protein \& Fiber - Variant 2 Receives: Dietary Supplement: Beverage Variant 2 (medium gelation properties) |
| Interventional Product 3 | Active comparator | Protein \& Fiber - Variant 3 Receives: Dietary Supplement: Beverage Variant 3 (high gelation properties) |
| Comparator | Placebo comparator | Protein \& Fiber Receives: Other: Control group (no gelation property) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area Under the Curve (iAUC) of the composite appetite score (CAS)
Incremental Area Under the Curve (iAUC) of the composite appetite score (CAS) derived from a 100 mm visual analogue scale (VAS) questionnaire on appetite.
Measured: Time frame used to assess product difference are -5, +15, +30, +45, +60, +90, +120 minutes post product intake. Time frame collection is -120, -90, -60, -30, -5, +15, +30, +45, +60, +90, +120min post product intake.
Secondary outcomes (3)
Gastrointestinal (GI) smart questionnaire score
Measured: Time frame used to assess product difference is -5, +30, +60, +90 and +120 minutes post product intake. However, time frame for collection is -120, -60, -5, +30, +60, +90 and +120 minutes post product intake.
GI hormones (ghrelin, GLP-1, PYY, GIP, CCK) levels postprandial and quantity of an ad libitum meal consumption 2hs after product intake and throughout the rest of the day
Measured: 5 minutes before IP intake and 15, 30, 45, 60, 90 and 120 minutes after IP intake
iAUC of the composite appetite score (CAS)
Measured: From -120, -90, -60, -30, -5 minutes before IP consumption to +15, 30, 60, 90 and 120 minutes after IP consumption, at V1, V2, V3 and V4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start22 May 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127198
- Sponsor's protocol ID
- 2405NR
- Status last verified
- Dec 2025
- First submitted
- 6 Jun 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties
- ClinicalTrials.gov ID
- NCT07127198
- Acronym / sponsor ID
- 2405NR
- Conditions
- Weight Management
- Keywords
- weight, drink
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 17 Aug 2025 (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.
The physical properties of a food product, such as its gelling properties in the stomach can influence how full a person may feel after its consumption. Decreasing appetite feeling through consumption of such a product with a low energy content may contribute to weight management.
The study will assess if a drink with gelation properties in the stomach can reduce appetite and therefore contribute to weight management.
This is a single-center, double-blinded, 4 arm cross-over randomized controlled study looking to enroll 24 adult participants. The study will be performed at the Clinical Innovation Lab (CIL), Nestlé Research, Lausanne. Enrolled participants will have 4 visit days after the screening visit. They will consume one of the test products, or control at each visit and complete the study assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Interventional Product 1 | Active comparator | Dietary Supplement: Beverage Variant 1 (low gelation properties)Protein \& Fiber - Variant 1 |
| Interventional Product 2 | Active comparator | Dietary Supplement: Beverage Variant 2 (medium gelation properties)Protein \& Fiber - Variant 2 |
| Interventional Product 3 | Active comparator | Dietary Supplement: Beverage Variant 3 (high gelation properties)Protein \& Fiber - Variant 3 |
| Comparator | Placebo comparator | Other: Control group (no gelation property)Protein \& Fiber |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female aged 18-65 years old (inclusive)
- Body Mass Index (BMI) 27 - 32kg/m2 (inclusive), measured and defined by the site
- Self-reported stable body weight for the past 6 months prior to screening (defined as not having gained or lost more than 5% of body weight)
- Comfortable using technology, such as a smartphone or laptop
- Willing and able to understand and sign a written informed consent prior to study entry
Key exclusion criteria (15 listed)
- Currently or in the last 3 months, use of medications affecting weight, study outcomes, including fat absorption such as, but not limited to: GLP-1 receptor analogues, SGLT-2 inhibitors, weight loss medications, medications that affect gastric pH, and any of the following drugs: cephaloridine, verapamil, valproic acid, and sulfonylureas, usually acting by competitive inhibition of L-carnitine transport by OCTN2, Orlistat, antacids, proton pump inhibitors, antibiotics, steroids or medications affecting thyroid hormones or gut hormones, antipsychotic medications, or antidepressants. As reported by participant.
- Diagnosed with Eating behaviour disorders such as emotional or restrained eating determined or any ongoing psychiatric illness. As reported by participant.
- Currently or within the last 3 months or planning to during the course of the study being on a weight loss regime (defined by actively following a diet such as Atkins, weight watchers, meal replacements, low or very low carbohydrate diet, ketogenic diet, intermediate fasting or enrolled into a governmental health program) or applying significant restrictions on food intake (i.e., regular breakfast skipping, regular cut on carbohydrates, regular intermittent fasting, diet reducing a specific macronutrient, diet significantly reducing calorie intake, excluding a group of food that was not excluded before). As reported by participant.
- Any known/suspected food allergies. As reported by participant.
- Currently pregnant, lactating, or breastfeeding. As reported by participant.
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 |
|---|---|---|
| Beverage Variant 1 (low gelation properties)The first interventional product for this study is a drink containing protein and fiber at a concentration 1. It will come in a ready to drink format for the participants. | Dietary supplement | Interventional Product 1 |
| Beverage Variant 2 (medium gelation properties)The first interventional product for this study is a drink containing protein and fiber at a concentration 2. It will come in a ready to drink format for the participants. | Dietary supplement | Interventional Product 2 |
| Beverage Variant 3 (high gelation properties)The first interventional product for this study is a drink containing protein and fiber at a concentration 3. It will come in a ready to drink format for the participants. | Dietary supplement | Interventional Product 3 |
| Control group (no gelation property)The control product for this study is a drink containing protein and fiber. It will come in a ready to drink format for the participants. | Other | Comparator |
Primary outcome
Incremental Area Under the Curve (iAUC) of the composite appetite score (CAS)
Time frame: Time frame used to assess product difference are -5, +15, +30, +45, +60, +90, +120 minutes post product intake. Time frame collection is -120, -90, -60, -30, -5, +15, +30, +45, +60, +90, +120min post product intake.
Incremental Area Under the Curve (iAUC) of the composite appetite score (CAS) derived from a 100 mm visual analogue scale (VAS) questionnaire on appetite.
3 secondary outcomes
Gastrointestinal (GI) smart questionnaire score
Time frame: Time frame used to assess product difference is -5, +30, +60, +90 and +120 minutes post product intake. However, time frame for collection is -120, -60, -5, +30, +60, +90 and +120 minutes post product intake.
GI hormones (ghrelin, GLP-1, PYY, GIP, CCK) levels postprandial and quantity of an ad libitum meal consumption 2hs after product intake and throughout the rest of the day
Time frame: 5 minutes before IP intake and 15, 30, 45, 60, 90 and 120 minutes after IP intake
iAUC of the composite appetite score (CAS)
Time frame: From -120, -90, -60, -30, -5 minutes before IP consumption to +15, 30, 60, 90 and 120 minutes after IP consumption, at V1, V2, V3 and V4
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 Dec 2025.
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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 Beverage Variant 1 (low gelation properties), Beverage Variant 2 (medium gelation properties) and Beverage Variant 3 (high gelation properties) in people with Weight Management, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 6 inclusion and 15 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 Dec 2025. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Incremental Area Under the Curve (iAUC) of the composite appetite score (CAS) (time frame: Time frame used to assess product difference are -5, +15, +30, +45, +60, +90, +120 minutes post product intake. Time frame collection is -120, -90, -60, -30, -5, +15, +30, +45, +60, +90, +120min post product intake.). 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 Dec 2025.