None listed
Conditions
Brief summary
Obesity is associated with a decreased quality of life along with an increased risk of a number of lifestyle-related 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, poor compliance – driven primarily by hunger and food cravings limits their effective application. Bitter plant extracts haves been shown to reduce daily hunger and decrease food intake when given before a meal. This reduction in appetite is from the stimulation of appetite suppressing gut hormones that are also linked to long term weight loss. We hypothesize that consumption of a bitter plant extract along with diet and exercise advice will improve the effectiveness of a weight loss intervention by lowering appetite and thereby making the diet easier to adhere to. We want to test this hypothesis on overweight to obese men and women who will be given either a bitter plant extract or a placebo daily, and have their weight, muscle and fat mass, appetite and food intake measured during a 24-week weight loss program.
Interventions
Hop extract intervention. Given in a delayed release hydroxypropyl methylcellulose oral capsule.
Daily Dosage:
Week 1: 125mg
Week2: 250mg
Week3: up to 375mg
Week4-24: up to 500mg
Individual participant sensitivity will be determined during the week 1-4 dose escalation period by self reported participant feedback on treatment tolerability.
Participants will continue on between 250-500mg for the rest of the study period. It is expected that the majority of participants will take 500mg, however
Hop extract intervention. Given in a delayed release hydroxypropyl methylcellulose oral capsule. Daily Dosage: Week 1: 125mg Week2: 250mg Week3: up to 375mg Week4-24: up to 500mg Individual participant sensitivity will be determined during the week 1-4 dose escalation period by self reported participant feedback on treatment tolerability. Participants will continue on between 250-500mg for the rest of the study period. It is expected that the majority of participants will take 500mg, however, as previous studies have suggested some variability in sensitivity, the dosage will be matched to tolerability to maximize participant retention. Compliance will be assessed monthly by study staff by assessing left over capsules.
Sponsors
New Zealand institute for bioeconomy science
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Male and pre-menopausal Female BMI 25-35 Aged 18-45 years Normal gross gastrointestinal tract anatomy, as ascertained by self-report Generally healthy as ascertained by self-report
Exclusion criteria
BMI outside range 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 follow dietary recommendations. 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 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