The Effect of Alginate Supplementation on Weight Management

Study Overview
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Alginate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy BMI over 20 Exclusion Criteria: Pregnant, lactating, BMI under 20

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, randomised, placebo controlled trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight