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N/A N=32 Randomized Quadruple-blind Health Services Research

Appetite Suppression Trial With Polydextrose

Body Weight · Non-restrained Eaters

Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women. — 2694; 2537; 2317; 2335 kJ — p=0.2918

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
12.5 g polydextrose (Dietary_supplement); glucose syrup (Dietary_supplement)
Age
Adult · 20+ yrs
Sex
Female
Sponsor
W.J. Pasman
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.
2694; 2537; 2317; 2335 0.2918
SECONDARY
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
358.3; 336.8; 356.7; 280.2; -424.7; -443.0 0.0109 sig
SECONDARY
Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
241.15; 265.03; -23479; -20902; 1745.5; 1210.5 0.0216 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02064205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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