None listed
Conditions
Brief summary
Background: Berryfruits supplementation is predicted to be able to activate satiety mechanisms which may suppress both hunger and food intake. Objective: The aims of the research are to determine whether berryfruits supplementation suppresses appetite, decreases the amount of food intake, and causes short-term weight loss. Design: This will be a 3-treatment cross-over intervention study comprising 20 overweight postmenopausal women. The study will compare two types of dietary fiber (boysenberry, inulin) and a non-fiber placebo (maltodextrin) supplementation. Each treatment will be self-administered 3 times a day for a 3 week period, separated by a minimum 3 weeks break. Participants will take part in a 4-month study, with 6 study visits to the Human Nutrition Unit. Outcome variables: Throughout the study visits, ratings of hunger, fullness and appetite related sensations will be measured via questionaires at various time intervals. Blood samples will also be collected different time points throughout the day for appetite hormones measurements. Energy intake will also be measured from the buffet lunch meal where they can eat as much as they want until comfortably full. In addition, participants will be asked to complete a 3-day food record prior to each study visit to see whether their hunger is changing. Participants will also be asked to take fecal sample prior to each study visit for analysis of short chain fatty acids and microorganisms to investigate whether the berryfruit drinks are altering bateria in their colon.
Interventions
The day after the study visit 1, visit 3 and visit 5 participants start 3 week supplementation of their normal diet with 1 of the 3 treatments. To minimize the potential for gastrointestinal discomfort, the fiber supplementation will be gradually built up over the first 7 days, to a maximum of 3 beverages/day providing a total of 16g fiber/day. As a further precaution only 1 sachet will be consumed with each meal to spread fiber delivery across the day e.g. a single sachet with each meal (breakf
The day after the study visit 1, visit 3 and visit 5 participants start 3 week supplementation of their normal diet with 1 of the 3 treatments. To minimize the potential for gastrointestinal discomfort, the fiber supplementation will be gradually built up over the first 7 days, to a maximum of 3 beverages/day providing a total of 16g fiber/day. As a further precaution only 1 sachet will be consumed with each meal to spread fiber delivery across the day e.g. a single sachet with each meal (breakfast, lunch and dinner). During the build-up on days 1-3, 1 sachet/day taken at breakfast, on days 4-6, two sachets/day with one taken at breakfast and another at dinner; then for days 7-21 three sachets/day with one taken at breakfast, lunch and dinner. All treatments are administered as a beverage, prepared by the participant on the day from a sealed sachet of powder mixed with water. The amount of boysenberry is 48 g containing 16 g of fiber is to be mixed with a minimum of 350 mL of water. The amount of inulin is 42 g containing 16 g of fiber is to be mixed with a minimum of 350 mL of water. Participants will be asked to keep all of the used sachets plus any unused sachet. Our research staff will monitor the participant by telephone three times a week. There will be a minimum of three-week wash-out period in between the treatments.
Sponsors
Plant and Food Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Female 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
Outcome results
None listed