None listed
Conditions
Brief summary
The inability to maintain energy balance is rapidly leading to an epidemic of weight gain and obesity worldwide, as well as nationally within New Zealand (Crowley, Yeo et al. 2002). 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. There is some evidence that lipid emulsions may aid satiety & weight control. A lipid emulsion is a mixture of two or more immiscible liquids. In lipid emulsion products, the lipid component (=dispersed phase) is dispersed in water (=the continuous phase). It has been suggested that the mechanism of action lipid emulsions is the ‘ileal brake’. Nutrient absorption from the proximal intestine is inhibited by the emulsion which then passes unabsorbed through into the distal intestine. It has been hypothesized that this may result in the generation of a peripheral satiety signal (Zhao et al 2000).
Interventions
The aim of this trial is to assess the effect of the particle size of orally ingested dairy-derived lipid emulsions on hunger, satiety and energy intake at a single ad libitum meal in human volunteers.
This study involves 4 visits to the Human Nutrition Unit. The first will be a brief screening visit (~30 minutes) where subjects will give their consent & complete questionnaires concerning their medical history, weight loss history & food preferences. We will also gather demographic & anthropome
The aim of this trial is to assess the effect of the particle size of orally ingested dairy-derived lipid emulsions on hunger, satiety and energy intake at a single ad libitum meal in human volunteers. This study involves 4 visits to the Human Nutrition Unit. The first will be a brief screening visit (~30 minutes) where subjects will give their consent & complete questionnaires concerning their medical history, weight loss history & food preferences. We will also gather demographic & anthropometrical data (age, gender, ethnicity, height, weight, body mass index (BMI) and waist & hip circumference). The trial design is a 3 treatment crossover, single day intervention study, comprising 20 lean male subjects (BMI = 18-25kg/m2) aged 18-65 years. At 9am on the morning of each visit subjects will be provided with a yoghurt breakfast containing of one of the 3 dairy treatments (10g emulsion or non-emulsion). Subjects must consume the breakfast meal in full. 3 hours later an ad libitum lunch meal will be provided. There will be a washout period of 3 days between study visit days. Each participant will complete all study arms of the study in a randomized order. The 3 treatments are: A = Small particle size dairy lipid/phospholipid emulsion B = Large particle size dairy lipid/phospholipid emulsion C = Non-emulsified dairy lipid/phospholipid The breakfast meals will comprise 10g of the dairy lipid treatment mixed in to a 190g yoghurt (total weight = 200g) The lunch meal will provide items served in moderate excess & participants will be instructed to eat as much or as little as they like until they feel comfortably full.
Sponsors
LactoPharma
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. male gender 2. aged 18-65y 3. lean (BMI:Causcasian/Indian/Asian 17.5-25kg/m2;Pacific peoples 18.5-26kg/m2) 4. healthy, as ascertained by self-report 5. desire to participate in clinical trial
Exclusion criteria
1. medications that may affect weight/appetite 2. cigarette smoking within previous 6 months 3. unwilling or unable to comply with protocol/ participation in another clinical trial 4. any current diagnosis or history of significant disease
Outcome results
None listed