The Effect of Alginate Supplementation on Weight Management

NCT04589273 | Unknown

• 1 other identifier: 1882/1283
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

obesity; overweight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in waist circumference

  12 weeks

• Change in fasting Cholesterol

  12 weeks

• Change in fasting Glucose

  12 weeks

• Change in fasting triacylglycerol

  12 weeks

Study Arms (2)

Alginate capsule

EXPERIMENTAL

The participants of this arm will be give the alginate capsules

Dietary Supplement: Alginate

Placebo

PLACEBO COMPARATOR

The participants of this arm will be give the placebo capsules

Other: Placebo

Interventions

Alginate DIETARY_SUPPLEMENT

Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.

Alginate capsule

Placebo OTHER

Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy
• BMI over 20

You may not qualify if:

• Pregnant, lactating,
• BMI under 20

Sponsors & Collaborators

• Newcastle University: lead

Study Sites (1)

Newcastle University

Newcastle, Tyne and Wear, NE2 4HH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Alginates

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Study Officials

• Pearson

  Newcastle University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pearson

CONTACT

01912086996; jeffrey.pearson@ncl.ac.uk

Wilcox

CONTACT

01912085013

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the researcher or the participant will know which arm of the trial they are part of.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomised, placebo controlled trial

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: October 19, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)