None listed
Conditions
Brief summary
Obesity is fast becoming an epidemic. A major initiative in the prevention of weight gain is to increase the satiating (=feelings of fullness) properties of food, whereby individuals naturally reduce their energy intake without having to consciously diet. Currently there is little information available as to the satiating effects of the different macronutrients within drinks. The aim of this study is to investigate the effects of dairy beverages on subjective ratings of hunger and fullness, and energy intake at a subsequent meal in a group of overweight women.
Interventions
This is a double-blind, randomised, cross-over study in overweight/obese women (Body Mass Index (BMI) 25-32kg/m2). This study is in two parts and will investigate (i) the effect of dairy beverages compared with zero energy water beverages, using a dose-escalating 4 treatment design, and (ii) the effect of dairy beverages compared with carbohydrate (CHO) -containing beverages, using a dose-escalating 6 treatment design. Both studies will be carried out using identical protocols and participant gr
This is a double-blind, randomised, cross-over study in overweight/obese women (Body Mass Index (BMI) 25-32kg/m2). This study is in two parts and will investigate (i) the effect of dairy beverages compared with zero energy water beverages, using a dose-escalating 4 treatment design, and (ii) the effect of dairy beverages compared with carbohydrate (CHO) -containing beverages, using a dose-escalating 6 treatment design. Both studies will be carried out using identical protocols and participant groups. A single test beverage (500ml) will be given on each study day. The trial beverages will be administered after a standardised evening meal and a standardised breakfast meal. The evening meal to be consumed the night before each treatment day (between 6-9pm) and the breakfast meal provided on the morning of the treatment are given in an attempt to minimise any carry-over effects of foods consumed prior to the intervention. The evening meals are given to the participants at their screen visit or study visit with clear instructions on how to store the meal and also how to prepare it. The breakfast meal is provided at the Human Nutrition Unit on the morning of the intervention at 9am. Specifically, the trial will measure the participants’ thoughts of hunger and fullness throughout a single day, and measure food intake at an ad libitum buffet style lunch meal given 120 minutes after the test beverage. Study visits to be separated by a wash-out period of at least 3 days. Test Beverages: Study 1 Dairy Beverage Dose Escalation Study: Control zero energy water beverage (0g dairy whey protein). Low dose (1%, 5g dairy whey protein) Medium dose (2%, 10g dairy protein), and High dose (4%. 20g dairy whey protein)dairy beverages. Participants will be ramdomized to recieve all 4 beverages detailed above over 4 study days. There must be at least 3 days between study visits. Participants are free to choose which days they come in to the unit so the study duration will be from 2 weeks to a couple of months if participants can only come in one day per week. Study 2 Dairy Beverage vs CHO Study: Control zero energy water beverage (0g dairy whey protein; 0g CHO) Medium (2%, 10g dairy protein), and High dose (4%, 20g dairy protein) dairy beverages. Low (2%, 10g CHO) Medium (4%, 20g CHO), and High dose (10%, 50g CHO) carbohydrate beverages. Participants will be ramdomized to recieve all 6 beverages detailed above over 6 study days. There must be at least 3 days between study visits. Participants are free to choose which days they come in to the unit so the study duration will be from 3 weeks to a few months if participants can only come in one day per week. The protein component will consist of a whey protein and the carbohydrate will be sucrose (=table sugar). Participants may take part in both study 1 and study 2. Participants may also just partcipate in either study 1 or study 2. If participants do wish to take part in both studies the minimum washout period between the studys is 3 days.
Sponsors
Fonterra Co-operative Group Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Female Age 18-45 years Overweight/mild obesity, as defined by BMI 25-32 kg/m2 Unrestrained eater as defined by the 3 Factor Eating Questionnaire (Stunkard & Messick, 1985) Healthy, as ascertained by self-report Signed consent given
Exclusion criteria
Endocrine, cardiovascular, gastrointestinal, metabolic disease or cancer/s including a history of these diseases as determined by the study physician. Pregnant or breast-feeding. Smoker or ex-smoker who quit within the last 6 months. Weight loss/gain of > 10% body weight within the last 6 months, as per self report. Actively taking part in a diet programme such as Jenny Craig, Weight Watchers, Slim Sure, Atkins Diet, South Beach Diet. Taking any medications for weight loss or other medications known to affect appetite regulation. Any medical conditions known to affect appetite related research parameters. Depression or any other anxiety disorder known to affect appetite. Hypersensitivities or allergies to any foods or ingredients included in the study. Restrained eater, as assessed from 3 Factor Eating Questionnaire (Stunkard & Messick, 1985). Dislike or can not eat any of the foods offered as part of the within the evening meal, breakfast or buffet. Unwilling/unable to comply with study protocol. Participating in another clinical intervention trial.
Outcome results
None listed