The Effect of Alginate Supplementation on Weight Management

Newcastle University

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Other: Placebo; Dietary Supplement: Alginate

Study type: Interventional

Funder types: Other

Identifiers

NCT04589273

1882/1283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy
• BMI over 20

Exclusion criteria

• Pregnant, lactating,
• BMI under 20

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups, including a placebo group

Alginate capsule

Experimental group

Description:

The participants of this arm will be give the alginate capsules

Treatment:

Dietary Supplement: Alginate

Placebo

Placebo Comparator group

Description:

The participants of this arm will be give the placebo capsules

Treatment:

Other: Placebo