The Effect of an Alginate Based Beverage on Weight Loss (ALGOBES)
This study has been completed.
Sponsor:
University of Copenhagen
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01231178
First received: April 8, 2010
Last updated: October 29, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Type 2 Diabetes Cardiovascular Disease |
Dietary Supplement: Alginate beverage Dietary Supplement: Control beverage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease. |
Resource links provided by NLM:
Further study details as provided by University of Copenhagen:
Primary Outcome Measures:
- Body weight [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Risk markers for type 2 diabetes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Risk markers for cardiovascular disease [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Body composition [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 96 |
| Study Start Date: | February 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Alginate based beverage |
Dietary Supplement: Alginate beverage
The dosage is 3x500ml daily
Other Name: Protanal
|
| Placebo Comparator: Control beverage |
Dietary Supplement: Control beverage
The dosage is 3x500ml daily
Other Name: Maltodextrin
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231178
Locations
| Denmark | |
| Department of Human Nutrition | |
| Frederiksberg, Copenhagen, Denmark, 1958 | |
Sponsors and Collaborators
University of Copenhagen
Investigators
| Principal Investigator: | Arne Astrup, Prof. MD. | Department of Human Nutrtion |
More Information
No publications provided by University of Copenhagen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Arne Astrup, MD, Head of Department, Department of Human Nutrition |
| ClinicalTrials.gov Identifier: | NCT01231178 History of Changes |
| Other Study ID Numbers: | B272, Scientific Ethical Committee |
| Study First Received: | April 8, 2010 |
| Last Updated: | October 29, 2010 |
| Health Authority: | Denmark: Ethics Committee |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Alginic acid Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013