The Effect of Alginate Supplementation on Weight Management

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Alginate; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pearson; Phone Number: 01912086996; Email: jeffrey.pearson@ncl.ac.uk
• Study Contact Backup: Name: Wilcox; Phone Number: 01912085013

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle, Tyne And Wear, United Kingdom, NE2 4HH
      • Recruiting
      • Newcastle University
      • Contact: Jeffrey P Pearson, PhD; Phone Number: 01912086996

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Generally healthy
• BMI over 20

Exclusion Criteria:

• Pregnant, lactating,
• BMI under 20

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alginate capsule; The participants of this arm will be give the alginate capsules	Dietary supplement: Alginate; Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.
Placebo Comparator: Placebo; The participants of this arm will be give the placebo capsules	Other: Placebo; Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	A change in weight measured in kg	12 weeks
Change in amount of body fat	A change in body fat (as a percentage) as measured by impedance	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in waist circumference	A change in waist circumference measured in cm	12 weeks
Change in fasting Cholesterol	A change in fasting circulating cholesterol	12 weeks
Change in fasting Glucose	A Change in fasting circulating glucose	12 weeks
Change in fasting triacylglycerol	A change in fasting circulating triacylglycerol	12 weeks

Collaborators and Investigators

• Sponsor: Newcastle University
• Investigators: Principal Investigator: Pearson, Newcastle University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: obesity; overweight
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 1882/1283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No