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Trial record 1 of 1 for:    NCT04292236
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The Effect of Food Supplements on Food Intake and Gut Hormone Levels

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ClinicalTrials.gov Identifier: NCT04292236
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : February 22, 2019
Actual Primary Completion Date : July 22, 2019
Actual Study Completion Date : July 22, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292236


Locations
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United Kingdom
Queen Mary University of Queensland
London, United Kingdom
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Madusha Peiris, PhD Queen Mary University of London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT04292236    
Other Study ID Numbers: QMREC2018/20
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Queen Mary University of London:
Nutrient
Anorexigenic hormone
Calorific Intake
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
3,3'-diindolylmethane
 Perilla seed oil
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents