Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties
NCT ID: NCT07127198
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2025-05-22
2025-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Interventional Product 1
Protein \& Fiber - Variant 1
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.
Interventional Product 2
Protein \& Fiber - Variant 2
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.
Interventional Product 3
Protein \& Fiber - Variant 3
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.
Comparator
Protein \& Fiber
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Body Mass Index (BMI) 27 - 32kg/m2 (inclusive), measured and defined by the site
3. 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)
4. Comfortable using technology, such as a smartphone or laptop
5. Willing and able to understand and sign a written informed consent prior to study entry
6. Deemed able to comply with the requirements of the study protocol and consume study products by study nurse
Exclusion Criteria
2. Diagnosed with Eating behaviour disorders such as emotional or restrained eating determined or any ongoing psychiatric illness. As reported by participant.
3. 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.
4. Any known/suspected food allergies. As reported by participant.
5. Currently pregnant, lactating, or breastfeeding. As reported by participant.
6. 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.
7. Acute GI upset (such as diarrhoea/constipation in the last 2 weeks, abdominal cramping etc.). As reported by participant.
8. Diagnosed with chronic GI disorder such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or irritable bowel syndrome. As reported by participant.
9. Ever underwent surgery for weight loss such as bariatric procedures or gastric bypass. As reported by participant.
10. Recent blood donation (\<8 weeks). As reported by participant.
11. Current or past smokers (stopped less than 3 months ago). As reported by participant.
12. Any drug abuse within the past year. As reported by participant.
13. 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.
14. Currently participating in another interventional study. As reported by participant.
15. Family or hierarchical relationships with the research team members. As reported by participant.
18 Years
65 Years
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Clinical Innovation Lab - Nestlé Research
Lausanne, , Switzerland
Countries
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Other Identifiers
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2405NR
Identifier Type: -
Identifier Source: org_study_id