Obesity (Disorder)NCT07437430
Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
A study of Obesity (Disorder), 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 pilot cross-over double blind RCT in obese adults aimed to test the feasibility of measuring food consumption over 24 hours after one-time administration of K sorbate versus placebo after participants reduce the background… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Obesity (Disorder)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Males and females age 20-80; BMI 30-39 kg/m2 inclusive; willingness and ability to follow the proposed study interventions and procedures; informed consent.
Who cannot join
- Weight loss of ≥3% in the last 3 months; previous or planned bariatric surgery in the next 1 year; current or planned participation in any structured weight-loss programs; current or recent (within the last 6 months) use of weight-loss-inducing drugs (including GLP-1 agonists); history of frequent intermittent or continuous use of systemic steroids; excessive alcohol consumption; recent or anticipated adjustments to mood, anxiety or anti-psychotic medications; untreated bipolar disorder or attention deficit hyperactivity disorder; eating disorder or any other disorder that may lead to significant weight changes; breastfeeding, pregnancy, planned pregnancy or planned fatherhood in the next 6 months; type 1 diabetes; uncontrolled diabetes mellitus (HbA1C≥9%); diabetes requiring treatment with insulin; aversion to foods that will be served during testing sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1
Natalia McInnes, MD, MSc, 9055212100 ext. 73794, natalia.mcinnes@mcmaster.ca
About this study
The effects of food additives on body weight in humans are largely unknown. This is a pilot cross-over double blind RCT in obese adults aimed to test the feasibility of measuring food consumption over 24 hours after one-time administration of K sorbate versus placebo after participants reduce the background consumption of related food additives.
- Conditions
- Obesity (Disorder)
- Being tested
- Potassium sorbate one-time administration followed by washout then placebo one-time administration, Placebo one-time administration followed by washout then potassium sorbate one-time administration
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium sorbate one-time administration followed by washout then placebo one-time administrationOther
K sorbate 450 mg will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then placebo administration with breakfast during testing session 2
Placebo one-time administration followed by washout then potassium sorbate one-time administrationOther
Placebo will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then K sorbate 450 mg administration with breakfast during testing session 2
| Study group | Role | What they receive |
|---|---|---|
| K sorbate one-time administration followed by washout then placebo one-time administration | Experimental | Not described Receives: Other: Potassium sorbate one-time administration followed by washout then placebo one-time administration |
| Placebo one-time administration followed by washout then K sorbate one-time administration | Experimental | Not described Receives: Other: Placebo one-time administration followed by washout then potassium sorbate one-time administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: Through active recruitment period (from the start of the recruitment period to the date the last participant could still be recruited into the study), anticipated to be 6 weeks.
Randomization rate
Measured: Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks.
Retention rate at the study end
Percentage of randomized participants who complete 2 testing sessions after randomization
Measured: Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks.
Adherence to the proposed dietary modifications on 24-hour dietary recalls conducted at or after randomization
Measured: From randomization till the end of the second testing session for each participant, anticipated average of 2 weeks.
Adverse events after randomization
Measured: From the time of randomization till study completion for each participant, anticipated average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start10 Feb 2026
- Primary completion1 Jun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Principal investigator, Natalia McInnes, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437430
- Sponsor's protocol ID
- 16738
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
- ClinicalTrials.gov ID
- NCT07437430
- Acronym / sponsor ID
- 16738
- Conditions
- Obesity (Disorder)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Feb 2026 (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 pilot cross-over double blind RCT in obese adults aimed to test the feasibility of measuring food consumption over 24 hours after one-time administration of K sorbate versus placebo after participants reduce the background consumption of related food additives.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K sorbate one-time administration followed by washout then placebo one-time administration | Experimental | Other: Potassium sorbate one-time administration followed by washout then placebo one-time administration |
| Placebo one-time administration followed by washout then K sorbate one-time administration | Experimental | Other: Placebo one-time administration followed by washout then potassium sorbate one-time administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and females age 20-80; BMI 30-39 kg/m2 inclusive; willingness and ability to follow the proposed study interventions and procedures; informed consent.
Key exclusion criteria (1 listed)
- Weight loss of ≥3% in the last 3 months; previous or planned bariatric surgery in the next 1 year; current or planned participation in any structured weight-loss programs; current or recent (within the last 6 months) use of weight-loss-inducing drugs (including GLP-1 agonists); history of frequent intermittent or continuous use of systemic steroids; excessive alcohol consumption; recent or anticipated adjustments to mood, anxiety or anti-psychotic medications; untreated bipolar disorder or attention deficit hyperactivity disorder; eating disorder or any other disorder that may lead to significant weight changes; breastfeeding, pregnancy, planned pregnancy or planned fatherhood in the next 6 months; type 1 diabetes; uncontrolled diabetes mellitus (HbA1C≥9%); diabetes requiring treatment with insulin; aversion to foods that will be served during testing sessions.
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 |
|---|---|---|
| Potassium sorbate one-time administration followed by washout then placebo one-time administrationK sorbate 450 mg will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then placebo administration with breakfast during testing session 2 | Other | K sorbate one-time administration followed by washout then placebo one-time administration |
| Placebo one-time administration followed by washout then potassium sorbate one-time administrationPlacebo will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then K sorbate 450 mg administration with breakfast during testing session 2 | Other | Placebo one-time administration followed by washout then K sorbate one-time administration |
Primary outcome
Recruitment rate
Time frame: Through active recruitment period (from the start of the recruitment period to the date the last participant could still be recruited into the study), anticipated to be 6 weeks.
Randomization rate
Time frame: Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks.
Retention rate at the study end
Time frame: Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks.
Percentage of randomized participants who complete 2 testing sessions after randomization
Adherence to the proposed dietary modifications on 24-hour dietary recalls conducted at or after randomization
Time frame: From randomization till the end of the second testing session for each participant, anticipated average of 2 weeks.
Adverse events after randomization
Time frame: From the time of randomization till study completion for each participant, anticipated average of 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity (Disorder), 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia McInnes, MD, MSc (19055212100 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: Through active recruitment period (from the start of the recruitment period to the date the last participant could still be recruited into the study), anticipated to be 6 weeks.). 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 27 Feb 2026.