ACTRN12615001301550Completed未知
In 20 overweight post-menopausal women, the effect of boysenberry drinks are compared with inulin (positive control) and maltodextrin (placebo) on appetite and food intake.
Plant and Food Research0 sites20 target enrollmentStarted: November 30, 2015Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (—)
- Sex
- Female
Inclusion Criteria
- •Aged 50-70 years
- •BMI between 25 and 35 kg/m2
- •Postmenopausal defined either by age greater than 60 years; or no menopausal cycle in the past 12 months.
- •Generally healthy, as ascertained by self-report
Exclusion Criteria
- •Any reported medical conditions or medications known to affect appetite -related parameters, including depression
- •Low iron status, hence unsuitable for cannulation studies
- •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
- •Body Mass Index greater than or equal to 35 kg/m2, or less than or equal to 25 kg/m2.
- •Reported major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- •Reported history of active uncontrolled gastrointestinal disorders or diseases including: inflammatory bowel disease (IBD), ulcerative colitis), Crohn's disease or indeterminate colitis; irritable bowel syndrome (IBS) (persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown aetiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated); chronic and recurring constipation of >5 days.
- •Reported use of any of the following drugs within the last 6 months: systemic antibiotics (intravenous, intramuscular, or oral); corticosteroids (oral, intravenous, intramuscular, nasal or inhaled); cytokines; methotrexate or immunosuppressive cytotoxic agents;
- •Large doses of commercial probiotics consumed (greater than or equal to108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
- •Acute disease at the time of enrolment (defer sampling until –participant recovers), included clinically raised blood pressure of >160/100 mm/Hg. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by reported medical history
- •Reported history of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
- •Reported positive test for HIV, HBV or HCV.
- •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
Investigators
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