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Completed

NCT Number: NCT04292236

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

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.

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Key information

Conditions

Obesity Appetite; Perverted Body Weight Endocrine; Obesity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary University of Queensland

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lauric Acid, Perilla Oil and Diindolylmethane

Dietary Supplement

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2020
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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