Fibersol-2 Clinical Trials Related to Appetite

• Visual analog scale questionnaire subjective satiety responses [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)
• serum cholecystokinin (CCK) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, and 240 min post-meal
• serum peptide YY (PYY) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, and 240 min post-meal
• serum glucagon-like peptide-1 (GLP-1) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, and 240 min post-meal
• serum ghrelin [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, and 240 min post-meal
• serum gastric inhibitory peptide (GIP) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, and 240 min post-meal

• serum total cholesterol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, 240 min
• serum LDL-cholesterol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, 240 min
• serum HDL-cholesterol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, 240 min
• serum triglycerides [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, 240 min
• serum free fatty acids [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 120, 180, 240 min
• serum glucose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 90, 120 min
• serum insulin [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  0, 30, 60, 90, 120 min
• gastrointestinal symptoms questionnaire [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
  subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h

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.

• Other: placebo
• Dietary Supplement: digestion-resistant maltodextrin
  Other Name: Fibersol-2

• Placebo Comparator: tea only without fibersol-2
  • 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.
  Intervention: Other: placebo
• Active Comparator: tea only with fibersol-2 (10 g)
  • 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.
  Intervention: Dietary Supplement: digestion-resistant maltodextrin
• Placebo Comparator: tea without fibersol-2 and meal
  • 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.
  Intervention: Other: placebo
• Experimental: tea with 5 g fibersol-2 and meal
  • 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.
  Intervention: Dietary Supplement: digestion-resistant maltodextrin
• Experimental: tea with 10 g fibersol-2 and meal
  • 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.
  Intervention: Dietary Supplement: digestion-resistant maltodextrin

Inclusion Criteria:

i. No known food allergies

ii. Normal healthy individuals

iii. No food intake abnormalities or abnormal feeding behaviors

iv. Average American BMI (21-28)