Recruiting

K Sorbate

Sponsor:

McMaster University

Code:

NCT07437430

Conditions

Obesity (Disorder)

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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 consumption of related food additives.

Conditions

Obesity (Disorder)

Study ID

NCT07437430

Start date

Feb 10, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: K sorbate one-time administration followed by washout then placebo one-time administration

experimental: Placebo one-time administration followed by washout then K sorbate one-time administration

Interventions

Potassium sorbate one-time administration followed by washout then placebo one-time administration

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 administration

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

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. ]
  • 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. ]
  • 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 ]

Central Contacts and Locations

Central contacts

Natalia McInnes, MD, MSc

19055212100natalia.mcinnes@mcmaster.ca

Locations

McMaster University Medical Centre

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Natalia McInnes, MD, MSc

9055212100natalia.mcinnes@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

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 2026-02-27.