Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties

NCT07127198 | Completed

• 1 other identifier: 2405NR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

weight; drink

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  5 minutes before IP intake and 15, 30, 45, 60, 90 and 120 minutes after IP intake

• iAUC of the composite appetite score (CAS)

  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

Other Outcomes (3)

• Blood insulin and blood amino acid levels

  5 minutes before IP intake and 15, 30, 45, 60, 90 and 120 minutes after IP intake

• iCmax and Tmax of the CAS.

  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

• Individual components of the composite VAS scores in response the 4 products

  From -120 minutes before IP intake to +120 minutes after IP intake atV1, V2, V3 and V4

Study Arms (4)

Interventional Product 1

ACTIVE COMPARATOR

Protein \& Fiber - Variant 1

Dietary Supplement: Beverage Variant 1 (low gelation properties)

Interventional Product 2

ACTIVE COMPARATOR

Protein \& Fiber - Variant 2

Dietary Supplement: Beverage Variant 2 (medium gelation properties)

Interventional Product 3

ACTIVE COMPARATOR

Protein \& Fiber - Variant 3

Dietary Supplement: Beverage Variant 3 (high gelation properties)

Comparator

PLACEBO COMPARATOR

Protein \& Fiber

Other: Control group (no gelation property)

Interventions

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.

Interventional Product 1

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.

Interventional Product 2

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.

Interventional Product 3

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.

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Lab - Nestlé Research

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Body Weight

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: August 17, 2025
• Study Start: May 22, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CH (1)