overweight and obesity obesity overweight
Conditions
Interventions
All subjects will receive all 6 treatments, which are described under 'study
design, in randomised order. Oral stimulation is done with modified sham
feeding (MSF) with cake, and gastric stimulation
Sponsors
Nestec
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male, healthy (based on subjects own judgement), aged between 18 and 40 years, BMI between 18.5 and 25 kg/m2, stable body weight (no changes larger than 5kg over the past 2 months)
Exclusion criteria
Exclusion criteria: • Smoking or drug use • Taking any medication, except for light pain relieving medications which are available over the counter (aspirin or paracetamol). • Gastro-intestinal diseases • Diabetes, thyroid diseases or any other endocrine disorders • Problems with the respiratory tract, such as hyperventilation, asthma or bronchitis, which can cause problems when the naso-gastric tube is inserted. • Lack of appetite for any reason • Restraint eating DEBQ score >= 2.26 (above average) • Hypersensitivity or food allergy for products used in this study • Currently participating or having participated in a clinical trial during the last 3 months prior to the beginning of this study. • Working at, or doing an MSc. thesis at the Division of Human Nutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is ad libitum energy intake of an ad libitum test meal served 30 minutes after start of the oral exposure/ intragastric infusion. To measure energy intake, the amount of provided food will be determined, as well as the leftovers. Chemical analyses will be performed to determine the exact energy and macronutrient content of the lunch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes measures are - subjective feelings of satiety that are measured via Visual Analogue Scale ratings. Hunger, fullness, prospective consumption, desire to eat, desire to eat something sweet, desire to eat something savoury, thirst, wellbeing and nauseous feelings will be rated. - gastric emptying rate will be measured with a non-invasive breath test. The gastric load which the subjects receive for the gastric stimulation will be labeled with a stable isotope: 13-C acetate. After some time part of the 13-C acetate will be present in the breath of the subjects. During a test day, 7 breath samples will be collected of a subject. The rate of gastric emptying will be determined by measuring the 13-C isotopic enrichmen in the collected breath samples. Gastric emptying rate of 1min/800ml treatment The gastric emptying rate of the 1min/800ml treatment will be compared to the control, to see whether it is significantly quicker. That might be the reason that we did not found a significant effect of gastric filling volume on ad libitum energy intake in our previous study. | — |
Countries
Netherlands
Outcome results
None listed