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

Nestlé

Status: Completed

Conditions: Weight Management

Treatments: Dietary Supplement: Beverage Variant 2 (medium gelation properties); Dietary Supplement: Beverage Variant 1 (low gelation properties); Dietary Supplement: Beverage Variant 3 (high gelation properties); Other: Control group (no gelation property)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07127198

2405NR

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female aged 18-65 years old (inclusive)
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

1. 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.
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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Interventional Product 1

Active Comparator group

Description:

Protein \& Fiber - Variant 1

Treatment:

Dietary Supplement: Beverage Variant 1 (low gelation properties)

Interventional Product 2

Active Comparator group

Description:

Protein \& Fiber - Variant 2

Treatment:

Dietary Supplement: Beverage Variant 2 (medium gelation properties)

Interventional Product 3

Active Comparator group

Description:

Protein \& Fiber - Variant 3

Treatment:

Dietary Supplement: Beverage Variant 3 (high gelation properties)

Comparator

Placebo Comparator group

Description:

Protein \& Fiber

Treatment:

Other: Control group (no gelation property)