NCT04292236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

February 20, 2020

Last Update Submit

February 27, 2020

Conditions

ObesityEndocrine; ObesityAppetite; Perverted

Keywords

NutrientAnorexigenic hormoneCalorific Intake

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Effect on gut hormone levels

    Study day 1 and study day 2 with samples taken every 30 min

  • Effect on satiety scores

    Study day 1 and study day 2 (following meal intake at breakfast and lunch)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Administered at time 0 min and 300 min. Cellulose was used as the placebo.

Dietary Supplement: Lauric Acid, Perilla Oil and Diindolylmethane

Dietary Supplement

ACTIVE COMPARATOR

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

Interventions

Lauric Acid, Perilla Oil and DiindolylmethaneDIETARY_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.

Dietary SupplementPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Major gut surgery
  • Major health problems
  • Taking medication for diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University of Queensland

London, United Kingdom

Location

Related Publications (1)

  • Peiris M, Aktar R, Reed D, Cibert-Goton V, Zdanaviciene A, Halder W, Robinow A, Corke S, Dogra H, Knowles CH, Blackshaw A. Decoy bypass for appetite suppression in obese adults: role of synergistic nutrient sensing receptors GPR84 and FFAR4 on colonic endocrine cells. Gut. 2022 May;71(5):928-937. doi: 10.1136/gutjnl-2020-323219. Epub 2021 Jun 3.

    PMID: 34083384DERIVED

MeSH Terms

Conditions

Obesity

Interventions

lauric acidperilla seed oil3,3'-diindolylmethane

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Madusha Peiris, PhD

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Double blinded, randomised, crossover, placebo controlled.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 3, 2020

Study Start

February 22, 2019

Primary Completion

July 22, 2019

Study Completion

July 22, 2019

Last Updated

March 3, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)