None listed
Conditions
Brief summary
The number of individuals who are overweight or obese is increasing dramatically both globally and within New Zealand. One of the major causes of weight gain is poor appetite control, where individuals overeat (eat more than is required to maintain their current weight) either because they do not generate physiological signals of ‘fullness’ and ‘stop eating’, or because the pleasure associated with eating overrides these signals. We believe that delivering bitter plant compounds to the gut may regulate appetite and potentially be a possible way to suppress appetite and help people lose weight. This study will give a non-toxic bitter plant extract to people then measure if it affects how much food they eat and how full they feel
Interventions
The study is a randomised, double-bind cross-over treatment in 20 healthy male participants and will involve the delivery of commonly consumed dietary bitter compounds (oral capsules) or placebo control, to assess its effects on appetite and energy intake. Capsules will be given to the participants at the time of the treatment to ensure they are taken. The study will be of 3 days duration, during which time 3 treatment arms each of 1 day duration will be completed in randomized order with at least a 7-day washout between treatments. The 3 treatment arms consist of 2 bitter phytochemical treatments and 1 placebo control. All treatments comprise of 2 capsules, one acid stable one taken 60 minutes before the lunch and one non-acid stable one taken 30 minutes before the lunch. For the 3 arms participants will receive either: 1. 2 placebo capsules (Placebo) at 30 and 60 minutes prior (acid stable capsule) to lunch. 2. A placebo at 60 minutes prior to lunch in the acid stable capsule and a 500mg plant extract (See non-public information for extract details) in a normal cellulose capsule at 30min prior to lunch (Stomach targeted) 3. A 500mg plant extract (See non-public information for extract details) in an acid stable capsule 60 minutes before lunch and a placebo in a normal cellulose capsule 30 minutes before lunch. The reason for the 2 different treatment locations is because animal studies have shown that the effect gastric exposure may differ from that of duodenal exposure. Treatments are suspended in food grade canola oil as a carrier to facilitate dispersion.
Sponsors
Study design
Eligibility
Inclusion criteria
Male Aged 18-55 years Normal stomach, small intestine and large bowel Generally healthy
Exclusion criteria
Overweight as defined by BMI >25kg/m2 Any medical conditions or medications known to affect appetite -related parameters, including depression