Overweight and ObesityNCT04589273
The Effect of Alginate Supplementation on Weight Management
A study testing Alginate in people with Overweight and Obesity, run by Newcastle University at 1 site in United Kingdom.
Trial summary
This project will assess the effect of the alginate (in a capsules) on the weight of generally healthy volunteers over a 12 week period. To achieve this, will recruit 150 (non-smoking) generally healthy volunteers to attend the study centre on four separate occasions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Alginate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2020to 31 Dec 2023
- 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
- Generally healthy
- BMI over 20
Who cannot join
- Pregnant, lactating,
- BMI under 20
Trial locations and contacts
1 site in 1 country.
Wilcox contact
United Kingdom1 site, 1 recruiting
- Recruiting
Newcastle University
Newcastle, Tyne and Wear, NE2 4HH
Jeffrey P Pearson, PhD, 01912086996
About this study
Official title: The Effect of Alginate Supplementation on Weight Management - A Randomised Double Blind Placebo Controlled Pilot Trial
This project will assess the effect of the alginate (in a capsules) on the weight of generally healthy volunteers over a 12 week period.
To achieve this, will recruit 150 (non-smoking) generally healthy volunteers to attend the study centre on four separate occasions. Volunteers will be randomly allocated into active or placebo arm of the trial, both will receive capsules with the same appearance.
The volunteers will have their height, weight, waist circumference, body composition, and fasting levels of circulating glucose, triacylglycerol and cholesterol measured at each for the four visits.
Read the detailed description
The study will last approximately 12 weeks depending on your availability.
Volunteers will be asked to come to the research facility in Newcastle University, before they have had any breakfast, on four separate occasions. The volunteers must not eat or drink anything (except water) after 8 pm the evening before they come in. This includes not drinking any alcohol, tea or coffee.
Each time the volunteers come in, their height (first assessment only), weight, waist circumference and body composition will be measured. Body composition is measured using scales which can determine the percentage of their body is fat or bone or muscle. This is done using a small harmless electrical current passing through their body, they will not detect or feel this at all. Their height will also be measured at the first visit. Cholesterol, triglyceride and glucose levels in the blood will also be measured at each visit. This will be done through a single finger prick blood sample.
Enough capsules will be given to the volunteers to last you four weeks at the first three visits. The capsules will be filled with either alginate or another dietary fibre believed to have no effect on weight management.
Volunteers will be asked to take four of these capsules with their three main meals per day over the 12 week study.
- Conditions
- Overweight and Obesity
- Being tested
- Alginate, Placebo
- Keywords
- obesity, overweight
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlginateDietary supplement
Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.
PlaceboOther
Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.
| Study group | Role | What they receive |
|---|---|---|
| Alginate capsule | Experimental | The participants of this arm will be give the alginate capsules Receives: Dietary Supplement: Alginate |
| Placebo | Placebo comparator | The participants of this arm will be give the placebo capsules Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
A change in weight measured in kg
Measured: 12 weeks
Change in amount of body fat
A change in body fat (as a percentage) as measured by impedance
Measured: 12 weeks
Secondary outcomes (4)
Change in waist circumference
A change in waist circumference measured in cm
Measured: 12 weeks
Change in fasting Cholesterol
A change in fasting circulating cholesterol
Measured: 12 weeks
Change in fasting Glucose
A Change in fasting circulating glucose
Measured: 12 weeks
Change in fasting triacylglycerol
A change in fasting circulating triacylglycerol
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 posted19 Oct 2020
- Study start19 Oct 2020
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomised, placebo controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pearson, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589273
- Sponsor's protocol ID
- 1882/1283
- Status last verified
- May 2023
- First submitted
- 8 Oct 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alginate Supplementation on Weight Management - A Randomised Double Blind Placebo Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04589273
- Acronym / sponsor ID
- 1882/1283
- Conditions
- Overweight and Obesity
- Keywords
- obesity, overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 2020 (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 project will assess the effect of the alginate (in a capsules) on the weight of generally healthy volunteers over a 12 week period.
To achieve this, will recruit 150 (non-smoking) generally healthy volunteers to attend the study centre on four separate occasions. Volunteers will be randomly allocated into active or placebo arm of the trial, both will receive capsules with the same appearance.
The volunteers will have their height, weight, waist circumference, body composition, and fasting levels of circulating glucose, triacylglycerol and cholesterol measured at each for the four visits.
Detailed description
The study will last approximately 12 weeks depending on your availability.
Volunteers will be asked to come to the research facility in Newcastle University, before they have had any breakfast, on four separate occasions. The volunteers must not eat or drink anything (except water) after 8 pm the evening before they come in. This includes not drinking any alcohol, tea or coffee.
Each time the volunteers come in, their height (first assessment only), weight, waist circumference and body composition will be measured. Body composition is measured using scales which can determine the percentage of their body is fat or bone or muscle. This is done using a small harmless electrical current passing through their body, they will not detect or feel this at all. Their height will also be measured at the first visit. Cholesterol, triglyceride and glucose levels in the blood will also be measured at each visit. This will be done through a single finger prick blood sample.
Enough capsules will be given to the volunteers to last you four weeks at the first three visits. The capsules will be filled with either alginate or another dietary fibre believed to have no effect on weight management.
Volunteers will be asked to take four of these capsules with their three main meals per day over the 12 week study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind, randomised, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Alginate capsule | Experimental | Dietary Supplement: AlginateThe participants of this arm will be give the alginate capsules |
| Placebo | Placebo comparator | Other: PlaceboThe participants of this arm will be give the placebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generally healthy
- BMI over 20
Key exclusion criteria (2 listed)
- Pregnant, lactating,
- BMI under 20
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 |
|---|---|---|
| AlginateVolunteers will be asked to consume the alginate capsules with each of their three main meals per day. | Dietary supplement | Alginate capsule |
| PlaceboVolunteers will be asked to consume the placebo capsules with each of their three main meals per day. | Other | Placebo |
Primary outcome
Change in Weight
Time frame: 12 weeks
A change in weight measured in kg
Change in amount of body fat
Time frame: 12 weeks
A change in body fat (as a percentage) as measured by impedance
4 secondary outcomes
Change in waist circumference
Time frame: 12 weeks
Change in fasting Cholesterol
Time frame: 12 weeks
Change in fasting Glucose
Time frame: 12 weeks
Change in fasting triacylglycerol
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Wilcox contact
Pearson 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 in people with Overweight and Obesity, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pearson (01912086996, jeffrey.pearson@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 1 Jun 2023.