The Effect of an Alginate Based Beverage on Weight Loss

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes; Cardiovascular Disease
• Interventions: Dietary Supplement: Alginate beverage; Dietary Supplement: Control beverage

• Registration Number: NCT01231178
• Lead Sponsor: University of Copenhagen

Brief Summary

The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink supplement on development in body weight and body composition, and risk markers for type-2 diabetes and cardiovascular disease in obese subjects.

Detailed Description

The study consists of a parallel RCT with 96 overweight/obese subjects enrolled into two treatment arms: placebo or active for 12 weeks. They will undergo examination at time points 0 and 12 weeks where a DXA scan will be performed to assess body composition and a fasting blood sample will be taken. At time points 0, 2, 4, 6, 8, 10 and 12 weeks their weight and waist circumference and number of test products not consumed will be recorded. In addition all subjects receive dietary counselling during the 12 weeks.

Study Timeline

• Study Start: 2010-02
• Status Verified: 2010-04
• Study First Submitted: 2010-04-08
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted QC: 2010-10-29
• Last Update Submitted: 2010-10-29
• Study First Posted: 2010-11-01
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Healthy men and women
• Overweight to obese (BMI 28-45 kg/m2)

Exclusion Criteria

• Chronic diseases including:liver and kidney disease, including P-Alanine aminotransferase (ALT), P-aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatinine kinase and P-lactate dehydrogenase (LD)> 2.0 times the upper limit of normal (ULN) (measured at the screening at the Department of Human Nutrition)
• systemic infections and metabolic diseases that can interfere with energy balance,
• diabetes or fasting blood glucose concentration> 7.0 mM, cardiovascular disease, systolic blood pressure ≥ 160 and / or a diastolic blood pressure ≥ 100 mmHg, hyperlipidemia (total cholesterol> 6.5 mM and triglycerides> 5.0 mM) (measured by the screening at the Department of Human Nutrition)
• Food allergies
• Psychiatric disorders and any clinical condition that makes the person unfit to participate in the experiment
• Use of dietary supplements (during the experimental period and 3 months before study start)
• Provision of blood for example. of donation or other scientific studies (during the trial and 3 months before study start) and hemoglobin <7.5 mmol / l (measured at the screening at the Department of Human Nutrition)
• Smoking (throughout the trial and 6 months before study start)
• Elite Athletes (> 10 hours strenuous exercise per week, self-reported)
• Women who are pregnant or breastfeeding, and post-menustruelle (self reported)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alginate based beverage	Alginate beverage	-
Control beverage	Control beverage	-

Primary Outcome Measures

Name	Time	Method
Body weight	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Blood pressure	12 weeks
Risk markers for type 2 diabetes	12 weeks
Risk markers for cardiovascular disease	12 Weeks
Body composition	12 Weeks

Trial Locations

Locations (1)

Department of Human Nutrition; 🇩🇰 Frederiksberg, Copenhagen, Denmark