The main objective is to evaluate the appetite suppressive effect of polydextrose, measured as the Energy Intake at ad libitum lunch (T=240 min) on normal weight and overweight women consuming 12.5 g of polydextrose or placebo in a low-fat yogurt as…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Energy, macronutrient and fiber intake from ad libitum lunch;
Appetite/satiety variables measured by VAS questionnaires: hunger,
satisfaction, fullness, prospective food consumption, and desire to eat,
Mood and well-being;
Satiety hormones: CCK, ghrelin, PYY and GLP-1
Glucose and insulin
Stomach emptying rate
Energy intake from diaries
Secondary outcome
see previous section
Background 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.
Study objective
The main objective is to evaluate the appetite suppressive effect of
polydextrose, measured as the Energy Intake at ad libitum lunch (T=240 min) on
normal weight and overweight women consuming 12.5 g of polydextrose or placebo
in a low-fat yogurt as a preload (T=150 min).
Study design
This is a double blind, placebo controlled, randomized, cross-over study.
Study burden and risks
The test product is a normal food ingredient, not posing any risk to the health
of the volunteers.
The blood collection may cause discomfort or bruising. Occasionally, fainting
or an infection at the blood sampling site can occur.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
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
10.Participants consuming more than 23 g of dietary fiber per day
11.Smoker in the last 3 months;
12.Heavy coffee drinkers (more than 6 cups a day);
13.High level of physical activity
14.Heavy alcohol consumers
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48027.056.14 |