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, hops extract can reduce subjective ratings of hunger experienced during the last 8h of a 24h water only fast in healthy men. We hypothesise that consumption of this same extract will also reduce subjective rating of hunger in females, and that this decrease will likely be linked to changes in the pro-appetite hormone ghrelin and to changes in energy substrate utilisation. To test this hypothesis 30 healthy females 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, subjective assessment of fast compliance, food cravings, blood glucose and ketone levels, ghrelin and leap-2 blood concentrations, and rebound eating.
Interventions
Subjects will consume, in a 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 hr and 14:00 hr), and treatments i, ii, and iii will occur on separate occasions. Study visits will be separated by at
Subjects will consume, in a 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 hr and 14:00 hr), 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 18:00 hr on the evening prior to study day, participants will be instructed to not consume any food or drinks other than water, with compliance determined by participant self-report. On each study day, subjects will begin the laboratory based assessments at 10:00 hr (t=0 min) and will complete visual analogue based questionnaires relating to appetite, food cravings, side effects, and fast difficulty throughout the study day, and have blood taken for measurement of appetite related hormones (Ghrelin and LEAP-2), blood glucose and ketones, and progesterone levels. Immediately following the first questionnaire and blood sample, 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 18:00 hr (t=480min) of the study day. Blood samples will be taken at 10:00 for all blood measures, at 12:00 for blood glucose and ketones and appetite related hormones, at 14:00 hr for blood glucose and ketones, at 16:00 hr for blood glucose and ketones, and at 18:00 hr for blood glucose and ketones and appetite related hormones. 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 18:00 hr, participants will be presented a high carbohydrate rice based ad libitum meal and asked to eat until comfortably full. At 18:30 hr subjects will be allowed to leave the laboratory.
Sponsors
The New Zealand Institute for Plant and Food Research
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 40 Years
Healthy volunteers
Yes
Inclusion criteria
Females Aged 18-40 years BMI 18.5-25kg/m2 Premenopausal 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. Regular menstrual cycle as ascertained by self-report
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 Unwilling/unable to comply with study protocol Conditions effecting the gastrointestinal tract Participating in another clinical intervention trial Abnormal hunger and meal patterns, as ascertained by self-assessment Any medical condition that may affect ability to safely participate in a 24h fast. Frequently take part in fasting or intermittent fasting Trying or likely to get pregnant Likely or planning to either start or stop taking hormonal-based contraception during the trial.
Outcome results
None listed