Safety and User Experience of BP-CBB

Официальное название

A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein CBB (BP-CBB)

Обзор

This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer experience with using the product, and to set the scene for future human studies documenting the health-benefits of daily supplementation with BP-CBB for diverse populations.

Вмешательства

• Пищевая добавка BP-CBB
  Dietary supplement containing BP-CBB
• Пищевая добавка Placebo
  Receives dietary supplement without BP-CBB

Первичные конечные точки

• To evaluate the safety and tolerability of once daily intake of the novel food ingredient BP-CBB in healthy adults [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Be able to give written informed consent.
• Be between 18-65 years, both inclusive.
• Record greater than 3 bowel movements recorded during the one-week run-in period.
• In general, in good health, as determined by the investigator.
• Willing to consume the Study Product once daily for the duration of the study.
• Willing to avoid pro, pre post biotics and any new supplements for the duration of the study

Критерии исключения

• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:

• Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
• Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
• Sexual partner(s) is/are exclusively female.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
• Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
• Has a history of drug and/or alcohol abuse.
• Has known food allergies, history of Type I (IgE-mediated) food allergies, or hypersensitivity or other issues with foods or ingredients that would preclude intake of the Study Product (i.e. soya).
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:

• Diagnosed gastrointestinal conditions
• Previous bariatric surgery
• Immunocompromised health conditions
• Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:

• Systemic antibiotics - in the 4 weeks prior to Visit 1
• Proton pump inhibitors (PPIs) - in the past 4 prior to Visit 1
• Non-steroidal anti-inflammatory drugs (NSAIDs) - in the past 2 weeks prior to Visit 1
• GLP-1 agonists - in the 12 weeks prior to Visit 1
• SGLT-2 inhibitors - in the 12 weeks prior to Visit 1
• Current or recent (in the 4-weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:

• Probiotics
• Prebiotics
• Synbiotics
• Postbiotics
• Regular (weekly) consumption of fermented food products (e.g. kefir, kombucha)
• Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, exercise, diet, change in body weight).
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
• Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Ирландия · 1 центр

• Atlantia Clinical Trials — Cork

Идентификаторы

NCT: NCT07628608 · AFCRO-204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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