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Recruiting NCT07437430

Evaluation of Food Additive Contributions to Obesity: Pilot Study 1

No phase Interventional Obesity (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Obesity (Disorder). Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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
  • Other 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 measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Other

Study locations

Canada · 1 center
  • McMaster University Medical Centre — Hamilton

Identifiers

NCT: NCT07437430 · 16738

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗