The Effect of Alginate Supplementation on Weight Management

Not Applicable

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Alginate; Other: Placebo

• Registration Number: NCT04589273
• Lead Sponsor: Newcastle University

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.

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-08
• Study Start: 2020-10-19
• Study First Posted: 2020-10-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Generally healthy
• BMI over 20

Exclusion Criteria

• Pregnant, lactating,
• BMI under 20

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alginate capsule	Alginate	The participants of this arm will be give the alginate capsules
Placebo	Placebo	The participants of this arm will be give the placebo capsules

Primary Outcome Measures

Name	Time	Method
Change in amount of body fat	12 weeks	A change in body fat (as a percentage) as measured by impedance
Change in Weight	12 weeks	A change in weight measured in kg

Secondary Outcome Measures

Name	Time	Method
Change in fasting Glucose	12 weeks	A Change in fasting circulating glucose
Change in waist circumference	12 weeks	A change in waist circumference measured in cm
Change in fasting Cholesterol	12 weeks	A change in fasting circulating cholesterol
Change in fasting triacylglycerol	12 weeks	A change in fasting circulating triacylglycerol

Trial Locations

Locations (1)

Newcastle University; 🇬🇧 Newcastle, Tyne And Wear, United Kingdom