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Effect of oral exposure duration and gastric energy content on gastric emptying rate

Effect of oral exposure duration and gastric energy content on gastric emptying rate - Gastric emptying study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37261
Enrollment
27
Registered
2012-08-24
Start date
2012-09-21
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overweight and obesity obesity overweight

Interventions

Treatments vary in oral exposure duration (0, 1 or 8 min) and in energy content of the gastric load (0, 100 or 700 kcal) in 500 ml. There are 5 different treatments: A: 1min oral exposure with 100kc

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Gender: male Age: 18 - 40 y BMI: 18.5 - 25.0 kg/m2 Healthy: as judged by the participant

Exclusion criteria

Exclusion criteria: • Smoking or drug abuse • Gastro-intestinal diseases • Diabetes, thyroid diseases or any other endocrine disorders • Lack of appetite for any reason • Hypersensitivity or food allergy for products used in this study • Currently participating in another clinical trial or planning to start participation during this study. • Taking any medication, except for light pain relieving medications which are available over the counter (acetylsalicylic acid or paracetamol). • Problems with the respiratory tract, such as hyperventilation, asthma or bronchitis, which can cause problems when the naso-gastric tube is inserted. • Working at, or doing an MSc. thesis at the Division of Human Nutrition

Design outcomes

Primary

MeasureTime frame
The primary outcomes is: differences in gastric emptying rates. Gastric emptying will be measured with a non-invasive breath test. Subjects will come to the study centre and will receive the gastric load which is labelled with a stable isotope: i.e. 13C. Breath samples will be collected at ten different moments: 2 before the treatment and 8 times after the treatment. In the breath samples the concentration of 13C (as part of 13CO2) will be determined as a measure for gastric emptying. The collected breath samples will be analysed for 13-C isotopic enrichment of the expired CO2 using Isotope Ratio Mass Spectrometry. The differences between the treatments in recovery of the isotope will be the outcome measures for gastric emptying.

Secondary

MeasureTime frame
The secondary outcome is: Subjective feelings of satiety: To measure subjective feelings of satiety, subjects will be asked multiple times to rate their feelings of satiety on a questionnaire. This *Appetite questionnaire* will consist of seven dimensions, i.e. hunger, fullness, prospective consumption, desire to eat, desire to eat something sweet, desire to eat something savoury, and thirst. The rating will be done by means of a Visual Analogue Scale (VAS), where subjects have to mark a spot on a 100 mm horizontal line. This will be done at nine different moments during each test session. Lines will be anchored by *not at all ** on the left side and *extremely ** on the right side.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)