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

Completed

• Conditions: not applicable; 10003018

• Registration Number: NL-OMON41091
• Lead Sponsor: TNO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Energy, macronutrient and fiber intake from ad libitum lunch;<br /><br>Appetite/satiety variables measured by VAS questionnaires: hunger,<br /><br>satisfaction, fullness, prospective food consumption, and desire to eat,<br /><br>Mood and well-being;<br /><br>Satiety hormones: CCK, ghrelin, PYY and GLP-1<br /><br>Glucose and insulin<br /><br>Stomach emptying rate<br /><br>Energy intake from diaries</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>see previous section</p><br>