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Evaluation of the effects of oral nutrients on gastric emptying, small intestinal transit, gastrointestinal hormones and appetite in humans

Evaluation of the acute effects of oral nutrients on gastric emptying, small intestinal transit, gastrointestinal hormones and appetite in humans in healthy males versus overweight and obese males

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000113055
Enrollment
60
Registered
2010-02-03
Start date
2008-05-20
Completion date
2011-04-01
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

To investigate the hypothesis that in overweight and obese subjects, oral ingestion of nutrients will be associated with attenuated slowing of gastric emptying and suppression of appetite and energy intake, when compared with lean subjects

Interventions

Gastric emptying and small intestinal transit will be measured using scintigraphy, which is the gold-standard for the measurement of gastric emptying, total, proximal and distal gastric volume and mouth-to-caecum transit. Subjects undergo a single test of 6 hours duration. Subjects will be asked to ingest a test drink comprising of 540 ml of Ensure (1 kcal/ml; 15% protein, 60% carbohydrate, 25 % fat) labelled with 20 MBq 99mTc-sulphur colloid. Gastric emptying will be measured by obtaining 1-m

Gastric emptying and small intestinal transit will be measured using scintigraphy, which is the gold-standard for the measurement of gastric emptying, total, proximal and distal gastric volume and mouth-to-caecum transit. Subjects undergo a single test of 6 hours duration. Subjects will be asked to ingest a test drink comprising of 540 ml of Ensure (1 kcal/ml; 15% protein, 60% carbohydrate, 25 % fat) labelled with 20 MBq 99mTc-sulphur colloid. Gastric emptying will be measured by obtaining 1-minute anterior and 1-minute posterior images, with the subject standing, at regular time points during 5 hrs. Regions-of-interest will be drawn around the total stomach and gastric emptying curves (expressed as % retention over time) will be derived for the total stomach. To evaluate intragastric meal distribution, the total stomach region of interest will be divided into proximal and distal regions, with the proximal region corresponding to the fundus and proximal corpus and the distal region corresponding to the distal corpus and antrum. The mouth-to-caecum transit will be evaluated as the time from ingestion of the meal to the arrival of the head of the meal at the caecum. At the end of the study, subjects will be provided with a cold buffet styled lunch to consume freeely for upto 30 min.

Sponsors

A/Prof Christine Feinle-Bisset
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention

Eligibility

Sex/Gender
Male
Age
18 Years to 56 Years
Healthy volunteers
Yes

Inclusion criteria

Subjects will all be males between age 18 -56 years, with a body mass index (BMI) of 18 - 25 kg/m2 for lean, 25 - 30 kg/m2 for over-weight and between 30 -35 kg/m2 for obese. Lean subjects will be required to be unrestrained eaters. All other subjects would have to had consume less than 20g of alcohol per week, be non-smokers, free of gastrointestinal or chronic disease and not currently taking medication.

Exclusion criteria

Each subject will be questioned prior to the study to exclude: (1)significant gastrointestinal symptoms; disease or surgery (2)current use of medications which may alter gastrointestinal motor function or appetite (3)diabetes mellitus (fasting glucose >6.9 mmol/l and/or glycated haemoglobin >6.2 %) (4)epilepsy (5)cardiovascular or respiratory disease (6)any other significant illness as assessed by the investigator (7)allergy to local anaesthetic (8)intake of > 20 g alcohol on a daily basis (9)smokers (10)individuals with food intolerances, allergies or vegetarians

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026