Evaluation of Food Additive Contributions to Obesity: Pilot Study 1

NCT07437430 | Recruiting

• 1 other identifier: 16738
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  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

  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

  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

  From randomization till the end of the second testing session for each participant, anticipated average of 2 weeks.

• Adverse events after randomization

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

Study Arms (2)

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

Interventions

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

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 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

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Academic Health Sciences Organization: collaborator

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Natalia McInnes, MD, MSc

CONTACT

19055212100; natalia.mcinnes@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 27, 2026
• Study Start: February 10, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CA (1)