Evaluation of Food Additive Contributions to Obesity: Pilot Study 1

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Recruitment rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From randomization till the end of the second testing session for each participant, anticipated average of 2 weeks.]
• Adverse events after randomization [Срок оценки: From the time of randomization till study completion for each participant, anticipated average of 3 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• McMaster University Medical Centre — Hamilton

Идентификаторы

NCT: NCT07437430 · 16738

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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