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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292236
• Other study ID #: QMREC2018/20
• Status: Completed
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: July 22, 2019

Study information

• Verified date: February 2020
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite; Perverted
• Endocrine; Obesity
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Queen Mary University of Queensland	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on appetite and satiety ratings	Effect on appetite measured as change in calorific intake	Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Secondary	Effect on gut hormone levels	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
Secondary	Effect on satiety scores	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)