ObesityNCT04236713
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3
A study testing Dietary intervention 1 and Dietary intervention 2 in people with Obesity, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary intervention 1 and Dietary intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2020to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >/=30 kg/m2
- willingness and ability to follow the proposed dietary interventions
- informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4K1
Natalia McInnes, MD, MSc
Natalia McInnes
About this study
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
- Being tested
- Dietary intervention 1, Dietary intervention 2
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention 1 | Experimental | Not described Receives: Other: Dietary intervention 1 |
| Dietary intervention 2 | Experimental | Not described Receives: Other: Dietary intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Average number of participants recruited per month
Measured: 0 months
Retention rate in arm 1
Percent of enrolled participants who complete the study
Measured: 5 months
Retention rate in arm 2
Percent of enrolled participants who complete the study
Measured: 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
Measured: 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
Measured: 2 to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start24 Jan 2020
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia McInnes, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236713
- Sponsor's protocol ID
- 7992
- Status last verified
- Apr 2020
- First submitted
- 4 Jan 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3
- ClinicalTrials.gov ID
- NCT04236713
- Acronym / sponsor ID
- 7992
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention 1 | Experimental | Other: Dietary intervention 1 |
| Dietary intervention 2 | Experimental | Other: Dietary intervention 2 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI >/=30 kg/m2
- willingness and ability to follow the proposed dietary interventions
- informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention 1Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week. | Other | Dietary intervention 1 |
| Dietary intervention 2Limiting 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. | Other | Dietary intervention 2 |
Primary outcome
Recruitment rate
Time frame: 0 months
Average number of participants recruited per month
Retention rate in arm 1
Time frame: 5 months
Percent of enrolled participants who complete the study
Retention rate in arm 2
Time frame: 5 months
Percent of enrolled participants who complete the study
Adherence to the dietary intervention in arm 1
Time frame: 2 to 5 months
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Adherence to the dietary intervention in arm 2
Time frame: 2 to 5 months
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention 1 and Dietary intervention 2 in people with Obesity, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia McInnes (905-521-2100 ext. 73794, natalia.mcinnes@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 0 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.