Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia

Study Overview
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Brief Summary
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Studies report that dietary fiber intake is inversely correlated with body weight gain. Previously, we have shown alginate fiber supplementation increases weight loss, which we ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One property of importance to appetite is the ability of alginate to gel in the acidic environment of the stomach. We hypothesize that the alginate will decrease the feeling of hunger and lower food consumption compared to control. Here we test three different beverages in a double-blinded crossover design, in which 24 participants will be randomly assigned to the sequence of the test days separated by at least 5 days. On each test day appetite sensation as well as blood glucose and insulin will be measured over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake calculated. The participants will also rate gastrointestinal confort.

Detailed Description
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Three different iso-caloric beverages will be tested in a double-blinded crossover design, in which 24 participants will be randomly assigned to the sequence of the test days separated by at least 5 days. Prior to the test days, the participants will follow a standardized fasting procedure: abstention from alcohol hard physical activity for 24 h; furthermore, consumption of the same evening meal no later than 8 pm on the night before all meal tests, after which time point they should be fasting. They are allowed 500 mL of water between 8 pm and the morning of the test days. On each test day, the participants will meet at the department in a fasting state. After voiding they will be weighed, and a venflon catheter will be inserted in the antecubital vein, allowing repeated blood sampling throughout the test day. Baseline measurements of blood pressure, blood samples, and visual analogue scales (VAS) scores will be conducted at time point of -15 min. A second baseline blood sample will be drawn at time point 0, immediately after which the participants will consume the preload beverage (time point 0) with a 10 min time limit for consumption. After consumption of the preload beverage, blood samples will be taken and VAS scores completed at time points 15 and 30 min, and hereafter the he standardized breakfast will be served for which 15 minutes is allowed (time point 30 min). After the participants have finished the breakfast, blood samples will be drawn and VAS scores completed at time points 45, 60, 90, 120, 180, 210 and 240 min. Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake calculated, and the final VAS score will be completed at time point 270 min after the participants have finished their lunch. Before leaving, the participants will fill in a questionnaire related to gastrointestinal adverse events (AE). As a pilot study, the first 6 participants to finish the study will be invited to participate in a fourth test day, on which capsules containing alginate fibers will be administered together with the placebo beverage. This fourth test day is not included in the randomization and will not be blinded for the participants.

Official Title
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Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Alginate dietary fiber
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight (BMI 25-35 kg/m2) Exclusion Criteria: Any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian) Smoking Use of dietary supplements up to 1 month before the first meal test Pregnancy or lactation Daily use of prescription medication (except for oral contraceptives) Any known chronic illnesses Participation in other intervention studies Non-adherence to the protocol or lack of cooperation Blood donation within 3 months prior to the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |
| Experimental: Low dose (1.5 g DF)<br> | Dietary Supplement: Alginate dietary fiber<br> <br> |
| Experimental: High dose (2.25 gDF)<br> | Dietary Supplement: Alginate dietary fiber<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings including derivative measures |  | Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad libitum food intake at the subsequent meal |  | Assessed after 4 hours after each of three test meals served at least 5 days apart | 
| Glucose and insulin response including derivative measures |  | Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart |