ObesityALSATNCT01720784
Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia
A study testing Alginate dietary fiber in people with Obesity, run by Arne Astrup at 1 site in Denmark.
Trial summary
Studies report that dietary fiber intake is inversely correlated with body weight gain. Previously, we have shown alginate fiber supplementation increases weight loss, which we ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Alginate dietary fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Jul 2013
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight (BMI 25-35 kg/m2)
Who cannot join
- Any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian)
- Smoking
- Use of dietary supplements up to 1 month before the first meal test
- Pregnancy or lactation
- Daily use of prescription medication (except for oral contraceptives)
- Any known chronic illnesses
Show all 9Show fewer
- Participation in other intervention studies
- Non-adherence to the protocol or lack of cooperation
- Blood donation within 3 months prior to the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, 1958
About this study
Studies report that dietary fiber intake is inversely correlated with body weight gain. Previously, we have shown alginate fiber supplementation increases weight loss, which we ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One property of importance to appetite is the ability of alginate to gel in the acidic environment of the stomach. We hypothesize that the alginate will decrease the feeling of hunger and lower food consumption compared to control.
Here we test three different beverages in a double-blinded crossover design, in which 24 participants will be randomly assigned to the sequence of the test days separated by at least 5 days.
On each test day appetite sensation as well as blood glucose and insulin will be measured over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake calculated. The participants will also rate gastrointestinal confort.
Read the detailed description
Three different iso-caloric beverages will be tested in a double-blinded crossover design, in which 24 participants will be randomly assigned to the sequence of the test days separated by at least 5 days. Prior to the test days, the participants will follow a standardized fasting procedure: abstention from alcohol hard physical activity for 24 h; furthermore, consumption of the same evening meal no later than 8 pm on the night before all meal tests, after which time point they should be fasting. They are allowed 500 mL of water between 8 pm and the morning of the test days.
On each test day, the participants will meet at the department in a fasting state. After voiding they will be weighed, and a venflon catheter will be inserted in the antecubital vein, allowing repeated blood sampling throughout the test day. Baseline measurements of blood pressure, blood samples, and visual analogue scales (VAS) scores will be conducted at time point of -15 min. A second baseline blood sample will be drawn at time point 0, immediately after which the participants will consume the preload beverage (time point 0) with a 10 min time limit for consumption. After consumption of the preload beverage, blood samples will be taken and VAS scores completed at time points 15 and 30 min, and hereafter the he standardized breakfast will be served for which 15 minutes is allowed (time point 30 min). After the participants have finished the breakfast, blood samples will be drawn and VAS scores completed at time points 45, 60, 90, 120, 180, 210 and 240 min.
Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake calculated, and the final VAS score will be completed at time point 270 min after the participants have finished their lunch. Before leaving, the participants will fill in a questionnaire related to gastrointestinal adverse events (AE).
As a pilot study, the first 6 participants to finish the study will be invited to participate in a fourth test day, on which capsules containing alginate fibers will be administered together with the placebo beverage. This fourth test day is not included in the randomization and will not be blinded for the participants.
- Conditions
- Obesity
- Being tested
- Alginate dietary fiber, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate dietary fiberDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Low dose (1.5 g DF) | Experimental | Not described Receives: Dietary Supplement: Alginate dietary fiber |
| High dose (2.25 gDF) | Experimental | Not described Receives: Dietary Supplement: Alginate dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective appetite ratings including derivative measures
Measured: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart
Secondary outcomes (2)
Ad libitum food intake at the subsequent meal
Measured: Assessed after 4 hours after each of three test meals served at least 5 days apart
Glucose and insulin response including derivative measures
Measured: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arne Astrup
- Sponsor type
- University, hospital or other
- Collaborators
- S-Biotek Holding ApS
- Responsible party
- Sponsor-investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720784
- Sponsor's protocol ID
- H-3-2012-101
- Other IDs
- B295
- Acronym
- ALSAT
- Status last verified
- Sep 2014
- First submitted
- 31 Oct 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia
- ClinicalTrials.gov ID
- NCT01720784
- Acronym / sponsor ID
- ALSAT / H-3-2012-101
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arne AstrupUniversity, hospital or other
- Collaborators
- S-Biotek Holding ApS
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Nov 2012 (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.
Studies report that dietary fiber intake is inversely correlated with body weight gain. Previously, we have shown alginate fiber supplementation increases weight loss, which we ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One property of importance to appetite is the ability of alginate to gel in the acidic environment of the stomach. We hypothesize that the alginate will decrease the feeling of hunger and lower food consumption compared to control.
Here we test three different beverages in a double-blinded crossover design, in which 24 participants will be randomly assigned to the sequence of the test days separated by at least 5 days.
On each test day appetite sensation as well as blood glucose and insulin will be measured over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake calculated. The participants will also rate gastrointestinal confort.
Detailed description
Three different iso-caloric beverages will be tested in a double-blinded crossover design, in which 24 participants will be randomly assigned to the sequence of the test days separated by at least 5 days. Prior to the test days, the participants will follow a standardized fasting procedure: abstention from alcohol hard physical activity for 24 h; furthermore, consumption of the same evening meal no later than 8 pm on the night before all meal tests, after which time point they should be fasting. They are allowed 500 mL of water between 8 pm and the morning of the test days.
On each test day, the participants will meet at the department in a fasting state. After voiding they will be weighed, and a venflon catheter will be inserted in the antecubital vein, allowing repeated blood sampling throughout the test day. Baseline measurements of blood pressure, blood samples, and visual analogue scales (VAS) scores will be conducted at time point of -15 min. A second baseline blood sample will be drawn at time point 0, immediately after which the participants will consume the preload beverage (time point 0) with a 10 min time limit for consumption. After consumption of the preload beverage, blood samples will be taken and VAS scores completed at time points 15 and 30 min, and hereafter the he standardized breakfast will be served for which 15 minutes is allowed (time point 30 min). After the participants have finished the breakfast, blood samples will be drawn and VAS scores completed at time points 45, 60, 90, 120, 180, 210 and 240 min.
Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake calculated, and the final VAS score will be completed at time point 270 min after the participants have finished their lunch. Before leaving, the participants will fill in a questionnaire related to gastrointestinal adverse events (AE).
As a pilot study, the first 6 participants to finish the study will be invited to participate in a fourth test day, on which capsules containing alginate fibers will be administered together with the placebo beverage. This fourth test day is not included in the randomization and will not be blinded for the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Low dose (1.5 g DF) | Experimental | Dietary Supplement: Alginate dietary fiber |
| High dose (2.25 gDF) | Experimental | Dietary Supplement: Alginate dietary fiber |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight (BMI 25-35 kg/m2)
Key exclusion criteria (9 listed)
- Any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian)
- Smoking
- Use of dietary supplements up to 1 month before the first meal test
- Pregnancy or lactation
- Daily use of prescription medication (except for oral contraceptives)
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 dietary fiber | Dietary supplement | High dose (2.25 gDF), Low dose (1.5 g DF) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Subjective appetite ratings including derivative measures
Time frame: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart
2 secondary outcomes
Ad libitum food intake at the subsequent meal
Time frame: Assessed after 4 hours after each of three test meals served at least 5 days apart
Glucose and insulin response including derivative measures
Time frame: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart
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 3 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 dietary fiber in people with Obesity, run by Arne Astrup 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 1 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 3 Sep 2014. 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?
Subjective appetite ratings including derivative measures (time frame: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2014.