None listed
Conditions
Brief summary
A critical factor in the regulation of energy balance is the control of energy intake. Long-term reduction in intake is likely to result in parallel reduction in body weight and adiposity. Long-term maintenance of such a regime however is notoriously difficult to achieve through conscious dieting. Increased consumption of high satiety foods may lead to the subconscious reduction in energy intake and loss of body weight in a large portion of the population unable to consciously restrict their intake to levels matching their expenditure. Whilst lipids are commonly associated with poor satiety and weight gain relative to other dietary macronutrients, specifically carbohydrate and protein, there is some evidence from investigations into both macro- and micro-lipid components of a hierarchy within the lipid group itself and that specific lipid groups or lipid components may provide useful tools through which higher satiety food products may be developed
Interventions
This is a randomised, cross-over study in lean male participants (Body Mass Index (BMI) 18-25kg/m2). This study is the first of three parts and will investigate whether a commercially available lipid emulsion (OlibraTM) delivered as a single bolus “shot” or within different food components (a yoghurt or a muffin) has a differential effect on satiety, hunger and energy intake at the next meal (3.75 h later)
Subjects will be requested to fast for 12 hours prior to the test day.
Participants wi
This is a randomised, cross-over study in lean male participants (Body Mass Index (BMI) 18-25kg/m2). This study is the first of three parts and will investigate whether a commercially available lipid emulsion (OlibraTM) delivered as a single bolus “shot” or within different food components (a yoghurt or a muffin) has a differential effect on satiety, hunger and energy intake at the next meal (3.75 h later) Subjects will be requested to fast for 12 hours prior to the test day. Participants will be randomized to receive each of 6 treatments (200g) over the study period. A single treatment will be given on each study day. The treatments will be administered at the Human Nutrition Unit on the morning of the intervention at 09:00am. Specifically, the trial will measure the participants’ thoughts of hunger and fullness throughout a single day, and measure food intake at an ad libitum buffet style lunch meal given 225 minutes after the treatment. Study visits to be separated by a wash-out period of at least 1 day. Treatments: Shots: A. 4.2g Control lipid + 10.8g water + 185g glass warm water B. 15g OlibraTM + 185g glass of water. Yoghurts: C. 125g high fat yoghurt + 33.5g low fat yoghurt + 4g polycal (Nutricia) + 12.5g palm olein + 25g water. D. 160g high fat yoghurt + 15g OlibraTM + 8g palm olein + 17g water. Non-Dairy Foods: E. Muffin + 4.2g palm olein + 81g water. F. Muffin + 15g OlibraTM + 81g water. Control lipid = palm olein; OlibraTM = commercially available ‘Slim Shot’; Polycal, Nutritia = a powdered, carbohydrate energy source, medical food containing maltodextrin. Participants will be randomized to receive all 6 treatments detailed above over 6 study days. The 6 treatments are matched for total weight (200g). The 2 shot treatments (A and B) are matched for energy (155.4 kJ). The yoghurts and non-dairy foods are all matched for total energy (1165kJ), protein (6.8g), fat (15g) and carbohydrate (CHO) (28.8g). There must be at least 1 day between study visits. Participants are free to choose which days they come in to the unit so the study duration will be from 10 days to a couple of months if participants can only come in one day per week.
Sponsors
Lactopharma
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed