The Effect of Alginate Supplementation on Weight Management
NCT ID: NCT04589273
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
190 participants
INTERVENTIONAL
2020-10-19
2023-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Alginate capsule
The participants of this arm will be give the alginate capsules
Alginate
Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.
Placebo
The participants of this arm will be give the placebo capsules
Placebo
Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.
Interventions
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Alginate
Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.
Placebo
Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.
Eligibility Criteria
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Inclusion Criteria
* BMI over 20
Exclusion Criteria
* BMI under 20
18 Years
ALL
Yes
Sponsors
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Newcastle University
OTHER
Responsible Party
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Principal Investigators
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Pearson
Role: PRINCIPAL_INVESTIGATOR
Newcastle University
Locations
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Newcastle University
Newcastle, Tyne and Wear, United Kingdom
Countries
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Central Contacts
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Wilcox
Role: CONTACT
Facility Contacts
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Jeffrey P Pearson, PhD
Role: primary
Other Identifiers
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1882/1283
Identifier Type: -
Identifier Source: org_study_id
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