Appetite Suppression Trial With Polydextrose

Study Overview
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Brief Summary
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Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that regulate satiety may play a role in weight management. Suppression of appetite may reduce energy intake, which in return may lead to body weight reduction. This study aims to verify the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight and overweight women.

Detailed Description
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Polydextrose is a well-tolerated, low calorie glucose polymer (4kJ/g) that can be easily incorporated into various food applications to replace sugar and fat (Auerbach et al., 2007). Polydextrose is poorly digested in the upper gastrointestinal tract and therefore shows fiber-like properties. The addition of polydextrose to foods may increase the satiating properties of foods. Previous studies have shown that: Consuming polydextrose-containing preloads (6.25 - 25.0 g polydextrose) resulted in a significant lower energy intake at lunch compared to the control (Astbury et al., 2013; Ranawana et al., 2013; Hull et al., 2012; King et al., 2005). Polydextrose is able to modify appetite ratings at low (6.25 - 12.5 g polydextrose) (Hull et al., 2012) and high doses (56.7 g/d) (Konings et al., 2013). Polydextrose (15.0 g) induced enhanced GLP-1 response after a high-fat meal in obese participants (Tiihonen et al., 2012). Therefore, it is hypothesized that with the consumption of 12.5 g polydextrose as compared with the placebo, appetite will be suppressed, resulting in: a lower consumption at lunch (energy intake at lunch) change in appetite scores (VAS) change in satiety hormones (CCK, PYY, GLP-1, ghrelin) change in glucose and insulin change in stomach emptying rate change in gastric wellbeing

Official Title
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A Double Blind, Placebo Controlled, Randomized, Cross-over Study to Assess the Effects of Polydextrose on Appetite Suppression and Its Mechanisms of Action in Healthy Women With a Normal Weight and Overweight Female Participants.

Conditions
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Body Weight, Non-restrained Eaters

Intervention / Treatment
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* Dietary Supplement: 12.5 g polydextrose
* Dietary Supplement: glucose syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, female participants aged 20-45 years inclusive BMI: 20-30 kg/m2 inclusive Written consent regarding participation after full information regarding all details of the study Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch) Exclusion Criteria: Pregnancy On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product Reported postmenopausal Having menstruation problems, e.g. PCOS Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.) Aversion towards products (yoghurt) provided in the study On-going use of any slimming preparations Any kind of dysfunction of digestive tract, food allergy, chronic constipation, recent/actual gastroenteritis Restrained eaters (score DEBQ >3.4) Participants consuming more than 23g of dietary fiber per day - P75 according to the Dutch National Food Consumption Survey - (as assessed with a general short questionnaire which gives estimation on the fiber intake. Exact fiber intake will not be calculated) Smoker in the last 3 months Heavy coffee drinkers (more than 6 cups a day) High level of physical activity: Participants who perform more than 3 hours of intense training/sport activity per week (this will not include normal cycling transport) Heavy alcohol consumers, no more than 14 units per week (1 unit represents 1 standard glass/portion of alcohol, independent of the type of alcoholic drink). Remark: When enough subjects are eligible (> 32), the women with the highest BMI will be selected to participate. At least 50% of the subjects will have a BMI ranging of 25-30. Also at least 50% of the women will be in the age range of 25-45 years. When more than 32 subjects are eligible the eldest subjects will be included. With respect to eligibility of the subjects: the BMI criterion always comes for age criterion, meaning that overweight is stressed to be of more importance for this study than age. Overweight will always come first, even when already > 50% of the women with a BMI 25-30 have been included. In this way the overweight group of women will be studied as much as possible.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Breakfast meal with or without polydextrose
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polydextrose or glucose syrup at breakfast<br>Breakfast with pre-load four hours before lunch | Dietary Supplement: 12.5 g polydextrose<br>* Appetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect.<br>* Other names: Litesse®Ultra TM;Dietary Supplement: glucose syrup<br>* Glucose syrup is used a control product for the polydextrose<br>|
| Placebo Comparator: Pre-load with yogurt and polydextrose or glucose later<br>Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch. | Dietary Supplement: 12.5 g polydextrose<br>* Appetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect.<br>* Other names: Litesse®Ultra TM;Dietary Supplement: glucose syrup<br>* Glucose syrup is used a control product for the polydextrose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. | Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later. | Four hours or 1.5 hour after consumption of a pre-load at up to day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption) | The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full) | one day | 
| Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women. | The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between. The satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B). Area under the curves were calculated of the time curves. | Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-load, satiety, energy intake, appetite