ObesityALGOBESNCT01231178
The Effect of an Alginate Based Beverage on Weight Loss
A study testing Alginate beverage in people with Obesity and Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes, Cardiovascular Disease
- What is being tested?
- Alginate beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Overweight to obese (BMI 28-45 kg/m2)
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.
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.
Read the 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.
- Conditions
- Obesity, Type 2 Diabetes, Cardiovascular Disease
- Being tested
- Alginate beverage, Control beverage
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate beverageDietary supplement
Also called Protanal
The dosage is 3x500ml daily
Control beverageDietary supplement
Also called Maltodextrin
The dosage is 3x500ml daily
| Study group | Role | What they receive |
|---|---|---|
| Alginate based beverage | Active comparator | Not described Receives: Dietary Supplement: Alginate beverage |
| Control beverage | Placebo comparator | Not described Receives: Dietary Supplement: Control beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 12 Weeks
Secondary outcomes (4)
Blood pressure
Measured: 12 weeks
Risk markers for type 2 diabetes
Measured: 12 weeks
Risk markers for cardiovascular disease
Measured: 12 Weeks
Body composition
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Arne Astrup, Prof. MD., Principal investigator, Department of Human Nutrtion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231178
- Sponsor's protocol ID
- B272
- Other IDs
- Scientific Ethical Committee
- Acronym
- ALGOBES
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22648709
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT01231178
- Acronym / sponsor ID
- ALGOBES / B272
- Conditions
- Obesity, Type 2 Diabetes, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alginate based beverage | Active comparator | Dietary Supplement: Alginate beverage |
| Control beverage | Placebo comparator | Dietary Supplement: Control beverage |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Overweight to obese (BMI 28-45 kg/m2)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alginate beverageAlso: ProtanalThe dosage is 3x500ml daily | Dietary supplement | Alginate based beverage |
| Control beverageAlso: MaltodextrinThe dosage is 3x500ml daily | Dietary supplement | Control beverage |
Primary outcome
Body weight
Time frame: 12 Weeks
4 secondary outcomes
Blood pressure
Time frame: 12 weeks
Risk markers for type 2 diabetes
Time frame: 12 weeks
Risk markers for cardiovascular disease
Time frame: 12 Weeks
Body composition
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- Derived from this study: PubMed 22648709Georg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Prof. MD. principal investigator
Department of Human Nutrtion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alginate beverage in people with Obesity and Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010.