None listed
Conditions
Brief summary
Control of food intake is of primary importance in maintaining good health and is central to the success of interventions designed to manage body weight and to reduce risk factors for metabolic disorder and its consequences, such as obesity, type-2 diabetes, cardiovascular disease and some cancers. We have recently demonstrated that activation of gastrointestinal bitter taste receptors using a highly bitter, non-nutritive, plant extract can suppress energy intake via the release of gut satiety hormones in lean healthy men. We hypothesise that consumption of this extract will also decrease energy intake at a subsequent ad libitum lunch meal and modify subjective rating of appetite in overweight or obese but otherwise healthy women. To test this hypothesis 30 overweight or obese women will be recruited into a randomised, double-blind, placebo controlled, cross-over study designed to investigate the acute effect of a single high (250 mg) or low (100 mg) dose of the extract verses a placebo (vehicle control) on energy intake and subjective ratings of appetite, palatability, nausea, tiredness and gastrointestinal side effects.
Interventions
The study is to determine the effectiveness of a natural dietary bitter plant extract at suppressing appetite and food intake in overweight females. The three treatment arms comprise an acute intervention of a single delayed release capsule containing either a high (250 mg) or low (100 mg) dose of a super-critical CO2 extract of hops (Humulus lupulus) compared with placebo (vehicle control) provided 1 hour before a standard breakfast (1.5 MJ) provided at 9am. A minimum of a 3 day washout period
The study is to determine the effectiveness of a natural dietary bitter plant extract at suppressing appetite and food intake in overweight females. The three treatment arms comprise an acute intervention of a single delayed release capsule containing either a high (250 mg) or low (100 mg) dose of a super-critical CO2 extract of hops (Humulus lupulus) compared with placebo (vehicle control) provided 1 hour before a standard breakfast (1.5 MJ) provided at 9am. A minimum of a 3 day washout period will then follow where participants revert to their normal diet before entering the next treatment arm of the study.
Sponsors
The New Zealand Institute for Plant & Food Research Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Female • Aged 18-50 years • Being overweight or obese as determined by a Body Mass Index greater than or equal to 25 kg/m2 and less than or equal to 35 kg/m2 • A waist-hip ratio of greater than 0.8 • Normal menstrual cycle • Normal gross gastrointestinal tract anatomy, as ascertained by self-report • Regular pattern of meal consumption (breakfast, lunch and dinner) as determined by self-report. • Generally healthy, as ascertained by self-report
Exclusion criteria
• Pregnant, trying to get pregnant or currently breast feeding • Any reported medical conditions or medications known to affect taste, appetite-related parameters, and gastrointestinal function. • Participation in an active diet program and/or loss/gain of >10% body weight within the last 6 months • No extreme food restriction as seen in anorexia nervosa or binge eating plus purging (vomiting/using laxatives) and/or excessive physical activity as seen in bulimia or similar eating disorders that alter body composition in a short space of time. • Highly restrained eater, as ascertained by a score of >18 on the cognitive restraint scale of the Three Factor Eating Questionnaire. • Smoker or ex-smoker who quit within the last 6 months • Acute disease at the time of enrolment (defer sampling until –participant recovers), • Hypersensitivities or allergies to any foods or ingredients included in the study • Dislike and/or unwilling to consume items listed as study foods • Unwilling/unable to comply with study protocol • Participating in another clinical intervention trial
Outcome results
None listed