Appetite Suppression Trial With Polydextrose

Not Applicable

Completed

Conditions: Body Weight
Non-restrained Eaters

Interventions: Dietary Supplement: 12.5 g polydextrose
Dietary Supplement: glucose syrup

Registration Number: NCT02064205

Lead Sponsor: W.J. Pasman

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 32

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pre-load with yogurt and polydextrose or glucose later	glucose syrup	Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch.
Pre-load with yogurt and polydextrose or glucose later	12.5 g polydextrose	Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch.
polydextrose or glucose syrup at breakfast	glucose syrup	Breakfast with pre-load four hours before lunch
polydextrose or glucose syrup at breakfast	12.5 g polydextrose	Breakfast with pre-load four hours before lunch

Primary Outcome Measures

Name	Time	Method
Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.	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.

Secondary Outcome Measures

Name	Time	Method
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)	one day	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)
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.	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.