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

NCT01720784 | Completed

• 2 other identifiers: H-3-2012-101B295
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

• Ratings of gastrointestinal discomfort during 24 hours following the test meals

  Assessed4 times over a 24 hour period after each of three test meals served at least 5 days apart

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Low dose (1.5 g DF)

EXPERIMENTAL

Dietary Supplement: Alginate dietary fiber

High dose (2.25 gDF)

EXPERIMENTAL

Dietary Supplement: Alginate dietary fiber

Interventions

Alginate dietary fiber DIETARY_SUPPLEMENT

High dose (2.25 gDF); Low dose (1.5 g DF)

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight (BMI 25-35 kg/m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arne Astrup: lead
• S-Biotek Holding ApS: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

DK (1)