The Effect of Food Supplements on Food Intake and Gut Hormone Levels

February 27, 2020 updated by: Queen Mary University of London
When a meal is eaten, nutrients activate the release of hormones from the bowel into the blood stream. Normally there is a large amount of hormone released, which tells the brain that an individual is full and to stop eating. When people gain weight and become overweight or obese, these hormone signals are reduced, resulting in these people eating more and gaining more weight. This study is investigating mechanisms which may break this cycle by using particular nutrients to restore reduced hormone levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Queen Mary University of Queensland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese but otherwise healthy volunteers,
  • body mass index (BMI) of 30-40 kg/m2
  • agreement to consume scheduled meals
  • ability to understand the study information sheet and instructions in English and able to provide informed consent.

Exclusion Criteria:

  • Not meeting any of the exclusion criteria above.
  • Major gut surgery
  • Major health problems
  • Taking medication for diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Administered at time 0 min and 300 min. Cellulose was used as the placebo.
Dietary supplement: Lauric Acid, Perilla Oil and Diindolylmethane
Colonic release capsules containing lauric acid (2400mg), perilla oil (2100mg) and diinodlylmethane (500mg) given to volunteers 1 hour prior to standardised breakfast and lunch meal. Placebo group given cellulose capsules of same volume prior to standardised breakfast and lunch meal.
Active Comparator: Dietary Supplement
Administered at 0 min and 300 min. Combination of lauric acid, perilla oil and diindolylmethane was used as the dietary supplement.
Dietary supplement: Lauric Acid, Perilla Oil and Diindolylmethane
Colonic release capsules containing lauric acid (2400mg), perilla oil (2100mg) and diinodlylmethane (500mg) given to volunteers 1 hour prior to standardised breakfast and lunch meal. Placebo group given cellulose capsules of same volume prior to standardised breakfast and lunch meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on appetite and satiety ratings
Time Frame: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Effect on appetite measured as change in calorific intake
Study day 1 and study day 2 (following meal intake at breakfast and lunch)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on gut hormone levels
Time Frame: Study day 1 and study day 2 with samples taken every 30 min
Assess changes to circulating levels of anorectic hormones GLP-1, PYY and orexigenic hormone Ghrelin.
Study day 1 and study day 2 with samples taken every 30 min
Effect on satiety scores
Time Frame: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Using a visual analogue scale measuring changes to hunger, satiety and fullness scores
Study day 1 and study day 2 (following meal intake at breakfast and lunch)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Principal Investigator: Madusha Peiris, PhD, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2019

Primary Completion (Actual)

July 22, 2019

Study Completion (Actual)

July 22, 2019

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QMREC2018/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Lauric Acid, Perilla Oil and Diindolylmethane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe