Skip to content

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

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 - JZ PDX Satiety

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41091
Enrollment
32
Registered
2014-03-17
Start date
2014-03-18
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

not applicable

Interventions

None listed

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
see previous section

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)