NCT04236713

Brief Summary

The effects of food additives on body weight in humans are largely unknown. This is a feasibility study in 10 obese adults who will be followed for 5 months. Eligible participants will be non-randomly assigned to 2 groups and will be taught how to limit the exposure to the studied food additives in their diet. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 24, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

January 4, 2020

Last Update Submit

April 4, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

  • Recruitment rate

    Average number of participants recruited per month

    0 months

  • Retention rate in arm 1

    Percent of enrolled participants who complete the study

    5 months

  • Retention rate in arm 2

    Percent of enrolled participants who complete the study

    5 months

  • Adherence to the dietary intervention in arm 1

    Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls

    2 to 5 months

  • Adherence to the dietary intervention in arm 2

    Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls

    2 to 5 months

Study Arms (2)

Dietary intervention 1

EXPERIMENTAL
Other: Dietary intervention 1

Dietary intervention 2

EXPERIMENTAL
Other: Dietary intervention 2

Interventions

Dietary intervention 1OTHER

Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.

Dietary intervention 1
Dietary intervention 2OTHER

Limiting dietary exposure to nitrites, sulfites and related food additives; limiting eating out to a maximum of 2 days per week; limiting drinking wine to a maximum of 2 days per week.

Dietary intervention 2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>/=30 kg/m2
  • willingness and ability to follow the proposed dietary interventions
  • informed consent

You may not qualify if:

  • previous or planned bariatric surgery in the next 1 year
  • current or planned participation in any structured weight-loss programs in the next 6 months
  • current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
  • excessive alcohol consumption
  • bipolar disorder or attention deficit hyperactivity disorder
  • current use of anti-depressant or anti-psychotic medications
  • eating disorder or any other active disorder that may lead to significant weight changes
  • pregnancy or planned pregnancy in the next 1 year
  • uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Natalia McInnes

CONTACT

905-521-2100natalia.mcinnes@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 22, 2020

Study Start

January 24, 2020

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)