The Effect of Alginate Supplementation on Weight Management

NCT ID: NCT04589273

Last Updated: 2023-06-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, randomised, placebo controlled trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Neither the researcher or the participant will know which arm of the trial they are part of.

Study Groups

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Alginate capsule

The participants of this arm will be give the alginate capsules

Group Type EXPERIMENTAL

Alginate

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Generally healthy
* BMI over 20

Exclusion Criteria

* Pregnant, lactating,
* BMI under 20
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Newcastle University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Pearson

Role: CONTACT

01912086996

Wilcox

Role: CONTACT

01912085013

Facility Contacts

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Jeffrey P Pearson, PhD

Role: primary

01912086996

Other Identifiers

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1882/1283

Identifier Type: -

Identifier Source: org_study_id

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