ObesityNCT03757962
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1
A study testing Dietary intervention 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 before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants will meet with the study team 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2018to 16 Jul 2019
- 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 intervention
- 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
- 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
Show all 9Show fewer
- working night shifts
- 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.
About this study
The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants will meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.
- Conditions
- Obesity
- Being tested
- Dietary intervention
- Keywords
- dietary modification
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Not described Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: 0 months
Retention rate
Measured: 5 months
Adherence to the dietary intervention
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months
Measured: 2 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start13 Nov 2018
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
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
- NCT03757962
- Sponsor's protocol ID
- 5157
- Status last verified
- Aug 2019
- First submitted
- 23 Nov 2018
- Last updated
- 20 Aug 2019
- 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 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1
- ClinicalTrials.gov ID
- NCT03757962
- Acronym / sponsor ID
- 5157
- Conditions
- Obesity
- Keywords
- dietary modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 29 Nov 2018 (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 before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants will meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: Dietary intervention |
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 intervention
- 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
- bipolar disorder or attention deficit hyperactivity disorder
- current use of anti-depressant or anti-psychotic medications
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 interventionLimiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week. | Other | Dietary intervention |
Primary outcome
Recruitment rate
Time frame: 0 months
Retention rate
Time frame: 5 months
Adherence to the dietary intervention
Time frame: 2 to 4 months
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 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: finished, as of the sponsor's last update on 20 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 0 months). The study lists 3 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 20 Aug 2019.