Triacylglycerol DigestionNCT03860337
The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal
A study testing Alginate Sausage in people with Triacylglycerol Digestion, run by Newcastle University at 1 site in United Kingdom.
Trial summary
This study will investigate the effect of an extract of brown seaweed, called alginate, on fat digestion. The extract has been cooked into sausages and the alginate sausages will be compared to the same sausages that do not contain alginate. People taking part in the study will come to the study centre twice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Triacylglycerol Digestion
- What is being tested?
- Alginate Sausage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2019to 19 Jun 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle University
Newcastle, Tyne and Wear, NE2 4HH
About this study
Official title: The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal - A Pilot Trial
This study will investigate the effect of an extract of brown seaweed, called alginate, on fat digestion. The extract has been cooked into sausages and the alginate sausages will be compared to the same sausages that do not contain alginate. People taking part in the study will come to the study centre twice. Once to have the alginate sausage meal or the normal sausage meal and on the second visit they will have the other meal so then end up having had both types of sausages. The level of fat in their blood will be monitored over the four hours after the meal. The rate and amount of fat that moves into the blood after a meal is an indication of the amount of fat digestion. We believe that less fat will be digested and move into the blood when the volunteers eat the alginate sausages compared to the normal sausages.
Read the detailed description
Alginate is an extract of brown seaweed and has been shown to reduce lipase activity in vitro. Lipase is a valid target for anti-obesity products as shown by the pharmaceutical drug orlistat which targets the same enzyme. Reducing the amount of lipase activity will reduce the amount of triacylglycerol (TAG) that will be digested and therefore absorbed and will be seen as a reduction in the level of circulating TAG in the blood. Adding alginate to a range of food products that are simple to include into the diet could help with the management of obesity. In this study, sausages containing alginate have been manufactured for us along with matched control sausage. The circulating TAG in the blood will be measured via fingerpick blood samples every 30 minutes for four hours after the volunteers have eaten either alginate sausages or normal sausages. The volunteers will come for two visits and consume the other sausage meal at the second so they will have had both types of sausage.
- Conditions
- Triacylglycerol Digestion
- Being tested
- Alginate Sausage, Control Sausage
- Keywords
- fat digestion, alginate, sausages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate SausageDietary supplement
Alginate sausage
Control SausageOther
Control Sausage
| Study group | Role | What they receive |
|---|---|---|
| Alginate then Control | Experimental | This group will be given the alginate then the control sausages Receives: Dietary Supplement: Alginate Sausage; Other: Control Sausage |
| Control then Alginate | Experimental | This group will be given the control then alginate sausages Receives: Dietary Supplement: Alginate Sausage; Other: Control Sausage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of circulating TAG in blood
mmol/L
Measured: 4 hours after the test meal
Secondary outcomes (1)
Concentration of circulating glucose in blood
mmol/L
Measured: 4 hours after the test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start13 May 2019
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triacylglycerol DigestionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey P Pearson, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860337
- Sponsor's protocol ID
- SAU 01615
- Status last verified
- Sep 2019
- First submitted
- 28 Feb 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal - A Pilot Trial
- ClinicalTrials.gov ID
- NCT03860337
- Acronym / sponsor ID
- SAU 01615
- Conditions
- Triacylglycerol Digestion
- Keywords
- fat digestion, alginate, sausages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 1 Mar 2019 (actual)
- 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.
This study will investigate the effect of an extract of brown seaweed, called alginate, on fat digestion. The extract has been cooked into sausages and the alginate sausages will be compared to the same sausages that do not contain alginate. People taking part in the study will come to the study centre twice. Once to have the alginate sausage meal or the normal sausage meal and on the second visit they will have the other meal so then end up having had both types of sausages. The level of fat in their blood will be monitored over the four hours after the meal. The rate and amount of fat that moves into the blood after a meal is an indication of the amount of fat digestion. We believe that less fat will be digested and move into the blood when the volunteers eat the alginate sausages compared to the normal sausages.
Detailed description
Alginate is an extract of brown seaweed and has been shown to reduce lipase activity in vitro. Lipase is a valid target for anti-obesity products as shown by the pharmaceutical drug orlistat which targets the same enzyme. Reducing the amount of lipase activity will reduce the amount of triacylglycerol (TAG) that will be digested and therefore absorbed and will be seen as a reduction in the level of circulating TAG in the blood. Adding alginate to a range of food products that are simple to include into the diet could help with the management of obesity. In this study, sausages containing alginate have been manufactured for us along with matched control sausage. The circulating TAG in the blood will be measured via fingerpick blood samples every 30 minutes for four hours after the volunteers have eaten either alginate sausages or normal sausages. The volunteers will come for two visits and consume the other sausage meal at the second so they will have had both types of sausage.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Alginate then Control | Experimental | Dietary Supplement: Alginate Sausage, Other: Control SausageThis group will be given the alginate then the control sausages |
| Control then Alginate | Experimental | Dietary Supplement: Alginate Sausage, Other: Control SausageThis group will be given the control then alginate sausages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- pregnant or lactating.
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 SausageAlginate sausage | Dietary supplement | Alginate then Control, Control then Alginate |
| Control SausageControl Sausage | Other | Alginate then Control, Control then Alginate |
Primary outcome
Concentration of circulating TAG in blood
Time frame: 4 hours after the test meal
mmol/L
1 secondary outcome
Concentration of circulating glucose in blood
Time frame: 4 hours after the test meal
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 2 Oct 2019.
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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.
Jeffrey P Pearson, PhD principal investigator
Newcastle University
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 Sausage in people with Triacylglycerol Digestion, run by Newcastle University at 1 site in United Kingdom.
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 1 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 2 Oct 2019. 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 United Kingdom. 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. 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?
Concentration of circulating TAG in blood (time frame: 4 hours after the test meal). 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 2 Oct 2019.