Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT04236713

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Dietary intervention 1

Dietary intervention 2

Study Details

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.

Conditions

Obesity

Study ID

NCT04236713

Start date

Jan 24, 2020

Status verified date

Apr, 2020

Completion date

Oct 15, 2021

Anticipated

Primary completion date

Oct 15, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dietary intervention 1

experimental: Dietary intervention 2

Interventions

Dietary intervention 1

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 2

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.

Primary outcome measure

  • Recruitment rate [ Time Frame: 0 months ]
  • Retention rate in arm 1 [ Time Frame: 5 months ]
  • Retention rate in arm 2 [ Time Frame: 5 months ]
  • Adherence to the dietary intervention in arm 1 [ Time Frame: 2 to 5 months ]
  • Adherence to the dietary intervention in arm 2 [ Time Frame: 2 to 5 months ]

Central Contacts and Locations

Central contacts

Natalia McInnes

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

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Principal Investigator:

Natalia McInnes

More Information

Sponsor

McMaster University

Last update posted

Apr 7, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2020-04-07.