Fibersol-2 Clinical Trials Related to Appetite

Study Overview
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Brief Summary
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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.

Official Title
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Fibersol-2 Clinical Trials Related to Appetite

Conditions
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Lack of Satiety

Intervention / Treatment
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* Other: placebo
* Dietary Supplement: digestion-resistant maltodextrin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: tea only without fibersol-2<br>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. | Other: placebo<br> <br> |
| Active Comparator: tea only with fibersol-2 (10 g)<br>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. | Dietary Supplement: digestion-resistant maltodextrin<br> <br> * Other names: Fibersol-2;|
| Placebo Comparator: tea without fibersol-2 and meal<br>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. | Other: placebo<br> <br> |
| Experimental: tea with 5 g fibersol-2 and meal<br>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. | Dietary Supplement: digestion-resistant maltodextrin<br> <br> * Other names: Fibersol-2;|
| Experimental: tea with 10 g fibersol-2 and meal<br>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. | Dietary Supplement: digestion-resistant maltodextrin<br> <br> * Other names: Fibersol-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale questionnaire subjective satiety responses | Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores) | 4 hours | 
| serum cholecystokinin (CCK) | 0, 30, 60, 120, 180, and 240 min post-meal | 4 hours | 
| serum peptide YY (PYY) | 0, 30, 60, 120, 180, and 240 min post-meal | 4 hours | 
| serum glucagon-like peptide-1 (GLP-1) | 0, 30, 60, 120, 180, and 240 min post-meal | 4 hours | 
| serum ghrelin | 0, 30, 60, 120, 180, and 240 min post-meal | 4 hours | 
| serum gastric inhibitory peptide (GIP) | 0, 30, 60, 120, 180, and 240 min post-meal | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum total cholesterol | 0, 30, 60, 120, 180, 240 min | 4 hours | 
| serum LDL-cholesterol | 0, 30, 60, 120, 180, 240 min | 4 hours | 
| serum HDL-cholesterol | 0, 30, 60, 120, 180, 240 min | 4 hours | 
| serum triglycerides | 0, 30, 60, 120, 180, 240 min | 4 hours | 
| serum free fatty acids | 0, 30, 60, 120, 180, 240 min | 4 hours | 
| serum glucose | 0, 30, 60, 90, 120 min | 2 hours | 
| serum insulin | 0, 30, 60, 90, 120 min | 2 hours | 
| gastrointestinal symptoms questionnaire | subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h | 24 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fiber, satiety response, hunger, CCK, PYY, ghrelin, GIP, GLP-1