Overweight and Obesity
Conditions
Keywords
obesity, overweight
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.
Interventions
DIETARY_SUPPLEMENTAlginate
Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.
OTHERPlacebo
Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.
Sponsors
Newcastle University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither the researcher or the participant will know which arm of the trial they are part of.
Intervention model description
Double blind, randomised, placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy * BMI over 20
Exclusion criteria
* Pregnant, lactating, * BMI under 20
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 12 weeks | A change in weight measured in kg |
| Change in amount of body fat | 12 weeks | A change in body fat (as a percentage) as measured by impedance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Glucose | 12 weeks | A Change in fasting circulating glucose |
| Change in fasting triacylglycerol | 12 weeks | A change in fasting circulating triacylglycerol |
Countries
United Kingdom
Contacts
Primary ContactPearson
Backup ContactWilcox
Outcome results
None listed