ipid emulsions and the control of body weight. Delivery Systems Study.
- Conditions
- Diet & NutritionDiet and Nutrition - Obesity
- Registration Number
- ACTRN12609000851268
- Lead Sponsor
- actopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 18
Men, aged 18-65years.
Lean (BMI: Caucasian/Indian/Asian 17.5-25 kg/m2; Pacific Peoples 18.5-26 kg/m2).
No history of diabetes or heart disease.
Healthy, as ascertained by self-report.
Desire to participate in clinical trial
Endocrine, cardiovascular, gastrointestinal (GI), metabolic disease or cancers, including history.
Weight change of +/-5 kg in the previous 6 months.
Medications that may affect weight/appetite.
Cigarette smoking within previous 6 months.
Unwilling unable to comply with protocol/participation in another clinical trial
Any current diagnosis or history of significant disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Energy Intake at ad libitum lunch meal. Lunch items will be weighed by research staff pre- and post-meal, and energy, fat, CHO and protein intake calculated using the dietary program Foodworks.[Timepoint: 270 minutes post-treatment.]
- Secondary Outcome Measures
Name Time Method Secondary Outcome 1: Visual Analogue Scale (VAS) scores for hunger and fullness.[Time points: t= -10, 15, 30, 45, 60, 90, 120, 150, 180, 210, 270, 330 and 390 mins. These time points are set assuming t=0 is the time the treatment is administered. Therefore any negative time points refer to a VAS measurement taken that many minutes before the treatment. Positive time points are for VAS measurements at that number of minutes post-treatment.];Secondary Outcome 2: Visual Analogue Scale (VAS) scores for thoughts of food and satisfaction.[Time points: t= -10, 15, 30, 45, 60, 90, 120, 150, 180, 210, 270, 330 and 390 mins. These time points are set assuming t=0 is the time the treatment is administered. Therefore any negative time points refer to a VAS measurement taken that many minutes before the treatment. Positive time points are for VAS measurements at that number of minutes post-treatment.]