None listed
Conditions
Brief summary
Obesity is associated with increased risk of a number of diseases including diabetes, heart disease, hypertension, and cancer. Traditional lifestyle treatments for obesity have focused on diet as both a preventative and treatment option and although diet has proven to be effective, recent discoveries have suggested that an intermittent fasting diet regime potentially offers greater health benefits when compared to classically prescribed diets. Intermittent fasting has been shown to be effective for the reduction of body weight, to decrease pro-inflammatory proteins and blood glucose levels, reduce heart rate, and to reduce blood pressure and insulin levels. However, intermittent fasting results in increased feeling of hunger during the fasting period (specifically during the 16-24h period) that may affect compliance to the intermittent fasting diet regime, and results in a certain degree of rebound eating post fast. The addition of an appetite suppressant to an intermittent fasting diet may reduce increased hunger levels and improve compliance. We have recently demonstrated that the gastrointestinal delivery of a highly bitter, non-nutritive, plant extract can stimulate the release of appetite-suppressing gut satiety hormones in lean healthy men. We hypothesise that consumption of this extract will also reduce subjective rating of hunger and improve compliance during hours 16-24h of a complete 24h fasting day, and reduce rebound eating post fast in healthy men. To test this hypothesis 30 healthy men will be recruited into a randomised, double-blind, placebo controlled, cross-over study designed to investigate the acute effect of a twice daily (10am, 2pm) high (2 x 250 mg) or low (2 x 100 mg) dose of the extract verses a placebo (2 x vehicle control) on subjective ratings of appetite, compliance and rebound eating and gastrointestinal side effects.
Interventions
Subjects will consume, in randomized, double-blind fashion (cross-over design), gastric digestion resistant capsules (DRCaps, Capsugel) containing i) 500mg (2x250mg) super critical CO2 extract of hops flower (Amarasate), ii) 200mg (2x100mg) Amarasate, or iii) matching placebo (control). Each subject will receive half the total treatment twice during a given study day (at 10:00 and 14:00), and treatments i, ii, and iii will occur on separate occasions. Study visits will be separated by at least 7
Subjects will consume, in randomized, double-blind fashion (cross-over design), gastric digestion resistant capsules (DRCaps, Capsugel) containing i) 500mg (2x250mg) super critical CO2 extract of hops flower (Amarasate), ii) 200mg (2x100mg) Amarasate, or iii) matching placebo (control). Each subject will receive half the total treatment twice during a given study day (at 10:00 and 14:00), and treatments i, ii, and iii will occur on separate occasions. Study visits will be separated by at least 7 days. During study laboratory visits, the lead researchers will be present to closely monitor adherence to study protocol. At 6pm on the evening prior to study day, participants will be instructed to not consume and food or drinks other than water, with compliance determined by participant self-report. On each study day, subjects will being the laboratory based assessments at 10:00 hr (t=0 min) and will complete appetite-related VAS and food cravings questionnaires throughout to study day. Immediately following the first questionnaire, subjects will ingest the first treatment capsules of either (i) 250mg Amarasate (ii), 100mg Amarasate or (iii) control, with 250 ml of water, within 2 mins. VAS questionnaires will be collected 30-min intervals from 10:00 (t=0 min) to 18:00h (t=480min) of the study day. Food craving questions will be asked at 10:00h, 12:00h, 14:00h, 16:00h and 18:00h. At 14:00h subjects will be giving the second treatment capsule (matched to the one given at 10:00h) of either (i) 250mg Amarasate (ii), 100mg Amarasate or (iii) control, with 250 ml of water and to be consumed within 2 mins. VAS and food craving questionnaires continue as described above. At 18:00h, subjects will be allowed to leave the laboratory.
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
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Males Aged 18-55 years BMI 20-25kg/m2 Normal gross gastrointestinal tract anatomy, as ascertained by self-report Generally healthy, as ascertained by self-report Regularly eat breakfast and lunch and dinner, as determined by self-reporting.
Exclusion criteria
Any medical conditions or medications known to affect appetite -related parameters, including depression, diabetes and glucose intolerance or supplements that regulate appetite. Participation in an active diet program and/or loss/gain of >10% body weight within the last 6 months Smoker or ex-smoker who quit within the last 6 months Hypersensitivities or allergies to any ingredients included in the study capsules Dislike and/or unwilling to consume items listed as study foods (i.e inability to swallow capsules) Unwilling/unable to comply with study protocol Conditions effecting the gastrointestinal tract Abnormal hunger and meal patterns, as ascertained by self-assessment Any medical condition that may affect ability to safely participate in a 24h fast. Current intake of any illegal substance(s) High performance athletes.
Outcome results
None listed