Clinical trial NCT04589273: The Effect of Alginate Supplementation on Weight Management
Official title: The Effect of Alginate Supplementation on Weight Management - A Randomised Double Blind Placebo Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Keywords: obesity
overweight
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomised, placebo controlled trial
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Generally healthy
* BMI over 20

Exclusion Criteria:

* Pregnant, lactating,
* BMI under 20

Primary outcomes:
measure: Change in Weight
timeFrame: 12 weeks
measure: Change in amount of body fat
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in waist circumference
timeFrame: 12 weeks
measure: Change in fasting Cholesterol
timeFrame: 12 weeks
measure: Change in fasting Glucose
timeFrame: 12 weeks
measure: Change in fasting triacylglycerol
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Newcastle University
state: Tyne And Wear
Study officials:
affiliation: Newcastle University
name: Pearson
role: PRINCIPAL_INVESTIGATOR
References: