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

Sponsor

Queen Mary University of London (Other)

Overall Status

Completed

CT.gov ID

NCT04292236

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Endocrine; Obesity Appetite; Perverted	Dietary Supplement: Lauric Acid, Perilla Oil and Diindolylmethane	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Double blinded, randomised, crossover, placebo controlled.Double blinded, randomised, crossover, placebo controlled.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 22, 2019

Actual Primary Completion Date :

Jul 22, 2019

Actual Study Completion Date :

Jul 22, 2019

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Effect on appetite and satiety ratings [Study day 1 and study day 2 (following meal intake at breakfast and lunch)]
Effect on appetite measured as change in calorific intake

Secondary Outcome Measures

Effect on gut hormone levels [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.
Effect on satiety scores [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary University of Queensland	London		United Kingdom

Sponsors and Collaborators

Queen Mary University of London

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Queen Mary University of London

ClinicalTrials.gov Identifier:

NCT04292236

Other Study ID Numbers:

QMREC2018/20

First Posted:

Mar 3, 2020

Last Update Posted:

Mar 3, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Queen Mary University of London

Nutrient

Anorexigenic hormone

Calorific Intake

Additional relevant MeSH terms:

Obesity

3,3'-diindolylmethane

Perilla seed oil

Study Results

No Results Posted as of Mar 3, 2020