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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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).
- •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-
- •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.
结局指标
主要结局
Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.
时间窗: Four hours or 1.5 hour after consumption of a pre-load at up to day 22
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.
次要结局
- The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)(one day)
- Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.(Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.)
研究者
W.J. Pasman
Project Manager Clinical Trials
TNO