Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia
Condition: Obesity
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Alginate dietary fiber; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention