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Effects of acute and longer-term energy restriction in lean and obese subjects on gut motility, hormones, appetite and energy intake in response to small intestinal nutrients and on oral fat perception

Effects of acute and longer-term energy restriction in lean and obese subjects on antropyloroduodenal motility, gut hormones, appetite and energy intake in response to duodenal nutrients and on oral fat perception

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000943246
Enrollment
24
Registered
2009-11-03
Start date
2009-12-01
Completion date
2011-12-31
Last updated
2026-03-30

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 effects of: (1) acute (4 days) energy restriction on GI function and appetite, in both lean and obese subjects, (2) prolonged (3 months) energy restriction on GI function, appetite and weight loss in obese subjects, in response to duodenal nutrients.

Interventions

Obese subjects will undergo a 12-week period of dietary restriction which will entail a 30% reduction of total energy intake, using a macronutrient-balanced (15% protein, 55% carbohydrate, 30% fat) diet. A standard 6000, 7000kJ and 8000kJ dietary intake using Lite and Easy menu structure will be utilised. Lean individuals will only be studied during a 4-day period of dietary restriction. During this time subjects will be given a complete meal plan to follow on a day-to-day basis and a meal che

Obese subjects will undergo a 12-week period of dietary restriction which will entail a 30% reduction of total energy intake, using a macronutrient-balanced (15% protein, 55% carbohydrate, 30% fat) diet. A standard 6000, 7000kJ and 8000kJ dietary intake using Lite and Easy menu structure will be utilised. Lean individuals will only be studied during a 4-day period of dietary restriction. During this time subjects will be given a complete meal plan to follow on a day-to-day basis and a meal check list to ensure they comply with the diet. The meal plan will contain a variety of foods for the subject to consume to ensure a varied diet. Compliance with the diet will be checked regularly throughout the study by a dietician, and subjects will be provided with all study food, including all meals and snacks, to facilitate adherence to the diet. Obese subjects will attend the laboratory on 4 days and lean subjects will attend on 2 days, to evaluate the effects of the dietary manipulations on GI motility, hormone release, appetite and energy intake in response to intraduodenl infusion of fat (Intralipid) at a rate of 2.86 kcal/min for 120 min. At the end of each study day, oral fatty acid taste thresholds will also be determined in each individual.

Sponsors

A/Prof Christine Feinle-Bisset
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Subjects will all be males between age 18 -55 years, with a body mass index (BMI) of 18 - 25 kg/m2 for lean and between 30 -35 kg/m2 for obese. Lean subjects will be required to be unrestrained eaters, 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: Apr 4, 2026