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

This study has been completed.
Sponsor:
Collaborator:
S-Biotek Holding A/S
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01720784
First received: October 31, 2012
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Alginate dietary fiber
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Subjective appetite ratings including derivative measures [ Time Frame: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ad libitum food intake at the subsequent meal [ Time Frame: Assessed after 4 hours after each of three test meals served at least 5 days apart ] [ Designated as safety issue: No ]
  • Glucose and insulin response including derivative measures [ Time Frame: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Ratings of gastrointestinal discomfort during 24 hours following the test meals [ Time Frame: Assessed4 times over a 24 hour period after each of three test meals served at least 5 days apart ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Placebo
Experimental: Low dose (1.5 g DF) Dietary Supplement: Alginate dietary fiber
Experimental: High dose (2.25 gDF) Dietary Supplement: Alginate dietary fiber

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720784

Locations
Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
Arne Astrup
S-Biotek Holding A/S
  More Information

No publications provided

Responsible Party: Arne Astrup, Head of Department, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01720784     History of Changes
Other Study ID Numbers: H-3-2012-101, B295
Study First Received: October 31, 2012
Last Updated: September 1, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Alginic acid
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014