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

NCT ID: NCT01720784

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-07-31

Brief 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Low dose (1.5 g DF)

Group Type: EXPERIMENTAL

Alginate dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

High dose (2.25 gDF)

Group Type: EXPERIMENTAL

Alginate dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Alginate dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

S-Biotek Holding ApS

OTHER

Sponsor Role: collaborator

Arne Astrup

OTHER

Sponsor Role: lead

Responsible Party

Arne Astrup

Head of Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, , Denmark

Countries

Denmark

Other Identifiers

B295

Identifier Type: -

Identifier Source: secondary_id

H-3-2012-101

Identifier Type: -

Identifier Source: org_study_id