ObesityPhase 1B247AlgobesNCT01101633
The Effect of Sodium Alginate on Appetite Sensation
A Phase 1 study testing Alginate in people with Obesity and Overweight, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Alginate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2009to Oct 2009
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Normal to slight overweight (BMI: 22-28 kg/m2)
- 20-45 years of age
Who cannot join
- Smoking
- Daily medicine use (oral contraceptives excluded)
- Use of dietary supplements
- Blood donation 3 months prior to the study
- Hb<7.5 mmol/l
- Chronic illnesses such as hyperlipidemia, diabetes and inflammatory diseases
Show all 9Show fewer
- Pregnancy or breastfeeding
- Elite athletes (>10 hours hard exercise/week)
- Vegetarians
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrtion, University of Copenhagen
Frederiksberg, Copenhagen, 1958
About this study
Official title: The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation
The aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development.
Read the detailed description
The project consists of two different studies:
Study I: A randomised controled meal test study aimed at studying the acute effect of the alginate-containing beverage on appetite sensation and spontaneous calorie intake (and safety i.e. nausea, well-being etc) in normal to overweight healthy subjects. Here, a placebo beverage or the alginate-containing beverage will be administered as a pre-load before a standardised breakfast meal. Subjective appetite sensation will be measured with Visual Analogue Scale (VAS) every 30 minutes four up to 5 hours. An additional beverage will be administered prior to an ad libitum lunch meal, where spontaneous water and energy intake will be registered.
Study II: Secondly the aim is to study the effects of a daily intake of a placebo or alginate-containing beverage on body weight and composition in a randomised parallel intervention study of 12 weeks duration. A total of app. 50 obese healthy adults will receive a hypocaloric diet and be randomised to consume either placebo or alginate-containing beverage before each of the three main meals every day. The development in body weight and composition and blood pressure will be monitored and blood samples will be analysed for markers related to the risk of CVD and type 2 diabetes.
- Conditions
- Obesity, Overweight
- Being tested
- Alginate, Placebo
- Keywords
- Appetite, Energy intake, gastric emptying, well being, Body weight
- Medical subject headings
- Obesity, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlginateDietary supplement
a 500 ml alginate beverage per meal test
AlginateDietary supplement
a 330 ml alginate beverage per meal test
PlaceboDietary supplement
a 500 ml placebo beverage per meal test
PlaceboDietary supplement
a 330 ml placebo beverage per meal test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 500 ml beverage containing alginate (3%) Receives: Dietary Supplement: Alginate |
| 2 | Active comparator | 330 ml beverage containing alginate (3%) Receives: Dietary Supplement: Alginate |
| 3 | Placebo comparator | 500 ml beverage without alginate (placebo) Receives: Dietary Supplement: Placebo |
| 4 | Placebo comparator | 330 ml beverage without alginate (placebo) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
appetite sensation
Measured: 5 hours
Secondary outcomes (4)
Plasma insulin and glucose level
Measured: 5 hours
Well being and adverse events
Measured: 5 hours
gastric emptying
Measured: 5 hours
spontaneous calorie intake
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionOct 2009
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- SBiotek
- Investigators
- Arne Astrup, Dr. Med, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101633
- Sponsor's protocol ID
- H-C-2008-088
- Acronym
- B247Algobes
- Status last verified
- Aug 2009
- First submitted
- 25 Aug 2009
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Georg Jensen M, Kristensen M, Belza A, Knudsen JC, Astrup A. Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects. Obesity (Silver Spring). 2012 Sep;20(9):1851-8. doi: 10.1038/oby.2011.232. Epub 2011 Jul 21.
PubMed 21779093
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation
- ClinicalTrials.gov ID
- NCT01101633
- Acronym / sponsor ID
- B247Algobes / H-C-2008-088
- Conditions
- Obesity, Overweight
- Keywords
- Appetite, Energy intake, gastric emptying, well being, Body weight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- SBiotek
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Apr 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 aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development.
Detailed description
The project consists of two different studies:
Study I: A randomised controled meal test study aimed at studying the acute effect of the alginate-containing beverage on appetite sensation and spontaneous calorie intake (and safety i.e. nausea, well-being etc) in normal to overweight healthy subjects. Here, a placebo beverage or the alginate-containing beverage will be administered as a pre-load before a standardised breakfast meal. Subjective appetite sensation will be measured with Visual Analogue Scale (VAS) every 30 minutes four up to 5 hours. An additional beverage will be administered prior to an ad libitum lunch meal, where spontaneous water and energy intake will be registered.
Study II: Secondly the aim is to study the effects of a daily intake of a placebo or alginate-containing beverage on body weight and composition in a randomised parallel intervention study of 12 weeks duration. A total of app. 50 obese healthy adults will receive a hypocaloric diet and be randomised to consume either placebo or alginate-containing beverage before each of the three main meals every day. The development in body weight and composition and blood pressure will be monitored and blood samples will be analysed for markers related to the risk of CVD and type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Alginate500 ml beverage containing alginate (3%) |
| 2 | Active comparator | Dietary Supplement: Alginate330 ml beverage containing alginate (3%) |
| 3 | Placebo comparator | Dietary Supplement: Placebo500 ml beverage without alginate (placebo) |
| 4 | Placebo comparator | Dietary Supplement: Placebo330 ml beverage without alginate (placebo) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- Normal to slight overweight (BMI: 22-28 kg/m2)
- 20-45 years of age
Key exclusion criteria (9 listed)
- Smoking
- Daily medicine use (oral contraceptives excluded)
- Use of dietary supplements
- Blood donation 3 months prior to the study
- Hb<7.5 mmol/l
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 |
|---|---|---|
| Alginatea 500 ml alginate beverage per meal test | Dietary supplement | 1 |
| Alginatea 330 ml alginate beverage per meal test | Dietary supplement | 2 |
| Placeboa 500 ml placebo beverage per meal test | Dietary supplement | 3 |
| Placeboa 330 ml placebo beverage per meal test | Dietary supplement | 4 |
Primary outcome
appetite sensation
Time frame: 5 hours
4 secondary outcomes
Plasma insulin and glucose level
Time frame: 5 hours
Well being and adverse events
Time frame: 5 hours
gastric emptying
Time frame: 5 hours
spontaneous calorie intake
Time frame: 5 hours
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 12 Apr 2010.
- Derived from this study: PubMed 21779093Georg Jensen M, Kristensen M, Belza A, Knudsen JC, Astrup A. Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects. Obesity (Silver Spring). 2012 Sep;20(9):1851-8. doi: 10.1038/oby.2011.232. Epub 2011 Jul 21.
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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, Dr. Med principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alginate in people with Obesity and Overweight, 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 3 inclusion and 9 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 12 Apr 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
appetite sensation (time frame: 5 hours). 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 NCT01101633, 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 12 Apr 2010.