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NCT Number: NCT07437430

Evaluation of Food Additive Contributions to Obesity: Pilot Study 1

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.

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Key information

Conditions

Obesity (Disorder) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location status: Recruiting

Location contact

Natalia McInnes, MD, MSc

CONTACT

[email protected]

9055212100 ext. 73794

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. Adverse events after randomization

    Time frame: From the time of randomization till study completion for each participant, anticipated average of 3 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia McInnes, MD, MSc

CONTACT

[email protected]

19055212100 ext. 73794

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Academic Health Sciences Organization

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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