The Effect of Alginate Supplementation on Weight Management

Overweight and Obesity Clinical Trial

Official title:

The Effect of Alginate Supplementation on Weight Management - A Randomised Double Blind Placebo Controlled Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589273
• Other study ID #: 1882/1283
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Newcastle University
• Contact: Pearson
• Phone: 01912086996
• Email: jeffrey.pearson[@]ncl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Generally healthy

• BMI over 20

Exclusion Criteria:

• Pregnant, lactating,

• BMI under 20

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Alginate
Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.

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

Locations

Country	Name	City	State
United Kingdom	Newcastle University	Newcastle	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	A change in weight measured in kg	12 weeks
Primary	Change in amount of body fat	A change in body fat (as a percentage) as measured by impedance	12 weeks
Secondary	Change in waist circumference	A change in waist circumference measured in cm	12 weeks
Secondary	Change in fasting Cholesterol	A change in fasting circulating cholesterol	12 weeks
Secondary	Change in fasting Glucose	A Change in fasting circulating glucose	12 weeks
Secondary	Change in fasting triacylglycerol	A change in fasting circulating triacylglycerol	12 weeks