The Effect of an Alginate Based Beverage on Weight Loss | NCT01231178

Studies
The Effect of an Alginate Based Beverage on Weight Loss

NCT01231178

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Nov 1, 2010Estimated

Enrollment

96Actual

Phase

Not Applicable

Conditions

Obesity
Type 2 Diabetes
Cardiovascular Disease

Interventions

Alginate beverage
Control beverage

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Scientific Ethical Committee	Registry Identifier	H-2-2009-155

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Oct 29, 2010

First Posted Date

Nov 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2010

Last Update Posted Date

Nov 1, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alginate based beverage	Active Comparator		Dietary Supplement: Alginate beverage
Control beverage	Placebo Comparator		Dietary Supplement: Control beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alginate beverage	Dietary Supplement	The dosage is 3x500ml daily	Alginate based beverage

Measure	Description	Time Frame
Body weight		12 Weeks

Measure	Description	Time Frame
Blood pressure		12 weeks
Risk markers for type 2 diabetes		12 weeks
Risk markers for cardiovascular disease

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Arne Astrup, Prof. MD.	Department of Human Nutrtion	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Human Nutrition		Frederiksberg	Copenhagen	1958	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22648709	Derived	Georg Jensen M, Kristensen M, Astrup A. Effect of alginate supplementation on weight loss in obese subjects completing a 12-wk energy-restricted diet: a randomized controlled trial. Am J Clin Nutr. 2012 Jul;96(1):5-13. doi: 10.3945/ajcn.111.025312. Epub 2012 May 30.

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
D002318	Cardiovascular Diseases

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases