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The Effect of Alginate Supplementation on Weight Management

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Alginate
Placebo
Sponsored by
Newcastle University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring obesity, overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Generally healthy
  • BMI over 20

Exclusion Criteria:

  • Pregnant, lactating,
  • BMI under 20

Sites / Locations

  • Newcastle UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alginate capsule

Placebo

Arm Description

The participants of this arm will be give the alginate capsules

The participants of this arm will be give the placebo capsules

Outcomes

Primary Outcome Measures

Change in Weight
A change in weight measured in kg
Change in amount of body fat
A change in body fat (as a percentage) as measured by impedance

Secondary Outcome Measures

Change in waist circumference
A change in waist circumference measured in cm
Change in fasting Cholesterol
A change in fasting circulating cholesterol
Change in fasting Glucose
A Change in fasting circulating glucose
Change in fasting triacylglycerol
A change in fasting circulating triacylglycerol

Full Information

First Posted
October 8, 2020
Last Updated
May 31, 2023
Sponsor
Newcastle University
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1. Study Identification

Unique Protocol Identification Number
NCT04589273
Brief Title
The Effect of Alginate Supplementation on Weight Management
Official Title
The Effect of Alginate Supplementation on Weight Management - A Randomised Double Blind Placebo Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
obesity, overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, randomised, placebo controlled trial
Masking
ParticipantInvestigator
Masking Description
Neither the researcher or the participant will know which arm of the trial they are part of.
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alginate capsule
Arm Type
Experimental
Arm Description
The participants of this arm will be give the alginate capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The participants of this arm will be give the placebo capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Alginate
Intervention Description
Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.
Primary Outcome Measure Information:
Title
Change in Weight
Description
A change in weight measured in kg
Time Frame
12 weeks
Title
Change in amount of body fat
Description
A change in body fat (as a percentage) as measured by impedance
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in waist circumference
Description
A change in waist circumference measured in cm
Time Frame
12 weeks
Title
Change in fasting Cholesterol
Description
A change in fasting circulating cholesterol
Time Frame
12 weeks
Title
Change in fasting Glucose
Description
A Change in fasting circulating glucose
Time Frame
12 weeks
Title
Change in fasting triacylglycerol
Description
A change in fasting circulating triacylglycerol
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Generally healthy BMI over 20 Exclusion Criteria: Pregnant, lactating, BMI under 20
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pearson
Phone
01912086996
Email
jeffrey.pearson@ncl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Wilcox
Phone
01912085013
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pearson
Organizational Affiliation
Newcastle University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newcastle University
City
Newcastle
State/Province
Tyne And Wear
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey P Pearson, PhD
Phone
01912086996

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Alginate Supplementation on Weight Management

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