Fibersol-2 Clinical Trials Related to Appetite
- Conditions
- Lack of Satiety
- Interventions
- Other: placeboDietary Supplement: digestion-resistant maltodextrin
- Registration Number
- NCT01305291
- Lead Sponsor
- Iowa State University
- Brief Summary
Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut. This research aims to determine whether or not Fibersol-2 may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
i. No known food allergies
ii. Normal healthy individuals
iii. No food intake abnormalities or abnormal feeding behaviors
iv. Average American BMI (21-28)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description tea only without fibersol-2 placebo * On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day. * The evening meal will be a standardized meal for all subjects (11). * They are allowed to consume water up until 1 hr before the test. * Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling (11). * The beverage will be consumed at 10 am. * Blood samples will be taken at specified time points prior to after the treatments. tea only with fibersol-2 (10 g) digestion-resistant maltodextrin * On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day. * The evening meal will be a standardized meal for all subjects. * They are allowed to consume water up until 1 hr before the test. * Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling (11). * The beverage will be consumed at 10 am. * Blood samples will be taken at specified time points prior to and after the treatments. * Ingredient only test will be done without the meal to determine independent effects of Fibersol-2. tea without fibersol-2 and meal placebo * On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day. * The evening meal will be a standardized meal for all subjects. * They are allowed to consume water up until 1 hr before the test. * Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling. * The test meal and beverage will be consumed at 10 am. * The meal will consist of pasta meal (main pasta dish = Carb 64.5%, Fat 17.7%, Protein 17.8%; total kcal 739). * Tea containing test materials will accompany the meal. * Blood samples will be taken at specified time points prior to and after the treatments. tea with 5 g fibersol-2 and meal digestion-resistant maltodextrin * On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day. * The evening meal will be a standardized meal for all subjects. * They are allowed to consume water up until 1 hr before the test. * Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling. * The test meal and beverage will be consumed at 10 am. * The meal will consist of pasta meal (main pasta dish = Carb 64.5%, Fat 17.7%, Protein 17.8%; total kcal 739). * Tea containing test materials will accompany the meal. * Blood samples will be taken at specified time points prior to and after the treatments. tea with 10 g fibersol-2 and meal digestion-resistant maltodextrin * On the day before the test, subjects need to consume their evening meal before 9 pm, and fast until the start of the test the next day. * The evening meal will be a standardized meal for all subjects. * They are allowed to consume water up until 1 hr before the test. * Before the start of the test a cannula will be inserted into the ante-cubital arm vein for use of repeated blood sampling. * The test meal and beverage will be consumed at 10 am. * The meal will consist of pasta meal (main pasta dish = Carb 64.5%, Fat 17.7%, Protein 17.8%; total kcal 739). * Tea containing test materials will accompany the meal. * Blood samples will be taken at specified time points prior to and after the treatments.
- Primary Outcome Measures
Name Time Method Visual analog scale questionnaire subjective satiety responses 4 hours Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)
serum cholecystokinin (CCK) 4 hours 0, 30, 60, 120, 180, and 240 min post-meal
serum peptide YY (PYY) 4 hours 0, 30, 60, 120, 180, and 240 min post-meal
serum glucagon-like peptide-1 (GLP-1) 4 hours 0, 30, 60, 120, 180, and 240 min post-meal
serum ghrelin 4 hours 0, 30, 60, 120, 180, and 240 min post-meal
serum gastric inhibitory peptide (GIP) 4 hours 0, 30, 60, 120, 180, and 240 min post-meal
- Secondary Outcome Measures
Name Time Method serum total cholesterol 4 hours 0, 30, 60, 120, 180, 240 min
serum LDL-cholesterol 4 hours 0, 30, 60, 120, 180, 240 min
serum HDL-cholesterol 4 hours 0, 30, 60, 120, 180, 240 min
serum triglycerides 4 hours 0, 30, 60, 120, 180, 240 min
serum free fatty acids 4 hours 0, 30, 60, 120, 180, 240 min
serum glucose 2 hours 0, 30, 60, 90, 120 min
serum insulin 2 hours 0, 30, 60, 90, 120 min
gastrointestinal symptoms questionnaire 24 h subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h
Trial Locations
- Locations (1)
Nutrition and Wellness Research Center
🇺🇸Ames, Iowa, United States