NCT02053025

Brief Summary

The purpose of this study is to investigate the effect of eating various levels of mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in overweight volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

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

March 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

2.6 years

First QC Date

January 22, 2014

Last Update Submit

October 14, 2019

Conditions

AppetiteEnergy Intake

Keywords

appetiteoverweightenergy intakeobesitygut hormones

Outcome Measures

Primary Outcomes (1)

  • Energy intake at ad-libitum meal

    Energy intake will be assessed during an ad-libitum meal at 180 minutes at the end of each study visit. Participants will be offered a meal in excess and asked to eat until they feel comfortably full. The meal will be weighed before and after consumption and energy intake will be calculated from the manufacturer's reported nutritional composition.

    upon completion of all participants, expected timeframe: 2 years

Secondary Outcomes (2)

  • Glucagon-like peptide-1 (GLP-1)

    upon completion of all participants, expected at 2 years

  • peptide tyrosine-tyrosine (PYY) levels

    upon completion of all participants, expected at 2 years

Study Arms (2)

mycoprotein

ACTIVE COMPARATOR

3 levels of mycoprotein will be consumed

Dietary Supplement: mycoprotein

control protein

ACTIVE COMPARATOR

3 levels of a control protein will be consumed

Dietary Supplement: control protein

Interventions

mycoproteinDIETARY_SUPPLEMENT
mycoprotein
control proteinDIETARY_SUPPLEMENT
control protein

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between the ages of 18 and 65
  • body mass index (BMI) 25-32kg/m2
  • Weight stable over the past 6 months
  • No known major illness or eating disorder nor on any medication that may impact on appetite or hormone levels.
  • No paracetamol or other analgesic in the previous 48 hours
  • A score of \<2.5 in the Dutch Eating Behaviour Questionnaire (DEBQ)
  • A score of \<2 in the SCOFF questionnaire

You may not qualify if:

  • Persons outside the age and BMI ranges stated above
  • Pregnant and lactating women
  • Weight variation of greater than 5% in the last 6 months
  • Any diagnosed major illness
  • Any paracetamol or analgesic intake in the last 48 hours
  • Diagnosed eating disorder
  • Allergy to mycoprotein or mushrooms
  • Regular consumption of Quorn products
  • Dislike of any of the test foods or drinks
  • A score of \>2.5 in the Dutch Eating Behaviour questionnaire
  • A score of 2 or more in the SCOFF questionaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College NIHR CRF

London, W12 0NN, United Kingdom

Location

Related Publications (1)

  • Bottin JH, Swann JR, Cropp E, Chambers ES, Ford HE, Ghatei MA, Frost GS. Mycoprotein reduces energy intake and postprandial insulin release without altering glucagon-like peptide-1 and peptide tyrosine-tyrosine concentrations in healthy overweight and obese adults: a randomised-controlled trial. Br J Nutr. 2016 Jul;116(2):360-74. doi: 10.1017/S0007114516001872. Epub 2016 May 20.

    PMID: 27198187RESULT

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gary Frost

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

February 3, 2014

Study Start

March 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)