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

Study Overview
=================
Brief 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.

Official Title
-----------------
The Effect of Food Supplements on Food Intake and Gut Hormone Levels

Conditions
-----------------
Obesity, Endocrine; Obesity, Appetite; Perverted

Intervention / Treatment
-----------------
* Dietary Supplement: Lauric Acid, Perilla Oil and Diindolylmethane


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double blinded, randomised, crossover, placebo controlled.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Administered at time 0 min and 300 min. Cellulose was used as the placebo. | Dietary Supplement: Lauric Acid, Perilla Oil and Diindolylmethane<br>* 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.<br>|
| Active Comparator: Dietary Supplement<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrient, Anorexigenic hormone, Calorific Intake