Clinical trial NCT02064205: Appetite Suppression Trial With Polydextrose
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Non-restrained Eaters
Keywords: pre-load
satiety
energy intake
appetite
Lead sponsor: TNO
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 32
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Breakfast meal with or without polydextrose
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: Inclusion Criteria:

1. Healthy, female participants aged 20-45 years inclusive
2. BMI: 20-30 kg/m2 inclusive
3. Written consent regarding participation after full information regarding all details of the study
4. Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch)

Exclusion Criteria:

1. Pregnancy
2. 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
3. Reported postmenopausal
4. Having menstruation problems, e.g. PCOS
5. Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.)
6. Aversion towards products (yoghurt) provided in the study
7. On-going use of any slimming preparations
8. Any kind of dysfunction of digestive tract, food allergy, chronic constipation, recent/actual gastroenteritis
9. Restrained eaters (score DEBQ \>3.4)
10. 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)
11. Smoker in the last 3 months
12. Heavy coffee drinkers (more than 6 cups a day)
13. 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)
14. 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.

Primary outcomes:
measure: Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.
timeFrame: Four hours or 1.5 hour after consumption of a pre-load at up to day 22
Secondary outcomes:
measure: The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
timeFrame: one day
measure: Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
timeFrame: Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS
Study officials:
affiliation: QPS, The Netherlands
name: Naguib Muhsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibarra A, Olli K, Pasman W, Hendriks H, Alhoniemi E, Raza GS, Herzig KH, Tiihonen K. Effects of polydextrose with breakfast or with a midmorning preload on food intake and other appetite-related parameters in healthy normal-weight and overweight females: An acute, randomized, double-blind, placebo-controlled, and crossover study. Appetite. 2017 Mar 1;110:15-24. doi: 10.1016/j.appet.2016.12.002. Epub 2016 Dec 2.