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The Effect of an Alginate Based Beverage on Weight Loss

NCT ID: NCT01231178

Last Updated: 2010-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Obesity Type 2 Diabetes Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alginate based beverage

Group Type ACTIVE_COMPARATOR

Alginate beverage

Intervention Type DIETARY_SUPPLEMENT

The dosage is 3x500ml daily

Control beverage

Group Type PLACEBO_COMPARATOR

Control beverage

Intervention Type DIETARY_SUPPLEMENT

The dosage is 3x500ml daily

Interventions

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Alginate beverage

The dosage is 3x500ml daily

Intervention Type DIETARY_SUPPLEMENT

Control beverage

The dosage is 3x500ml daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Protanal Maltodextrin

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Department of Human Nutrition

Principal Investigators

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Arne Astrup, Prof. MD.

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrtion

Locations

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Department of Human Nutrition

Frederiksberg, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 22648709 (View on PubMed)

Other Identifiers

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Scientific Ethical Committee

Identifier Type: REGISTRY

Identifier Source: secondary_id

B272

Identifier Type: -

Identifier Source: org_study_id