Feasibility and Colorectal Benefits of Pulses Supplementation

Официальное название

Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study

Обзор

Beans are a forgotten staple food that shows promise in improving health. The goal of this study is to look at how bean supplementation affects metabolic and bowel health. In the long-term, the investigators believe this research will lead to a better understanding of the impact of beans on bowel health. The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future.

Подробное описание

Investigators are seeking adults planning for a standard of care colonoscopies (part of the participant's usual care). As part of this feeding study, a participant will be randomly assigned to either two weeks of a dry bean smoothie that the investigators will provide in addition to the participant's usual diet or continue with participant's usual diet without the bean smoothie (including the food and drink guidelines for the colonoscopy) 2 weeks before or after the participant colonoscopy.

Participants' involvement in this research will also include 2 research visits plus a visit on the day of their scheduled standard-of-care colonoscopy (each research visit will be 30-60 minutes in length, scheduled close to 2-4 weeks prior to the colonoscopy, day of the colonoscopy, as well as 2-12 weeks after the colonoscopy, depending on participant availability. The investigators expect about 25 people aged 35-75 to participate in this research.

Participation in this study will involve collecting breath tests, fecal (stool) samples, 8 Teaspoons of blood, clinical data, and participant questionnaire data. At the time of colonoscopy, the investigators will also sample the mucosa lining of the bowel and remnant (leftover or discarded) tissue from an intestine biopsy obtained as part of the participant's clinical care. Participants will be asked to sign a separate HIPAA authorization form to allow the investigators to collect information from participant's medical records. This information will become part of the research data.

Вмешательства

• Пищевая добавка Dry beans
  0.5 cup of Bush's Best Cannellini Beans, three times per day before meals blended into a smoothie. If interested and depending on tolerance, participants will also have the opportunity to gradually increase the bean smoothie to a maximum of 1 cup three times per day before meals during the last week of the two-week bean smoothie intervention. If patient cannot not tolerate 1.5 cup of canned cannellini bean, we will reduce per tolerance or offer the option of choosing a bean-based flour (100 gram
• Пищевая добавка Usual diet
  Usual diet without adding the bean smoothie

Первичные конечные точки

• Compliance with the bean smoothie intervention [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Tolerance to the bean smoothie intervention [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Effect of the bean smoothie intervention on serum biomarkers of health [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change in fecal abundance of microbiome genes with bean smoothie intervention [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change from baseline in the fecal and serum metabolome with bean smoothie intervention [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Impact of bean intervention on colonic tissue RNA markers of health [Срок оценки: 2-4 weeks prior to colonoscopy till colonoscopy]

Вторичные конечные точки (5)

• Change from baseline in body composition [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change from baseline in body mass index (BMI) [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change from baseline in waist circumference [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Reported change from baseline in fitness level [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Reported change from baseline in and exercise per week [Срок оценки: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]

Критерии участия

Inclusions:

• 30-80 years-old
• Overweight or obesity (body mass index ≥ 25 kg/m2)
• Planned for a standard of care colonoscopy for colon cancer screening

Exclusions:

• Intolerance to a bean or high bean consumer based on a screening survey
• Pregnancy or actively planning to get pregnant
• Any active gastrointestinal disease resulting in disturbed gut function or malabsorption (e.g., chronic diarrhea or inflammatory bowel disease)
• Current or history of any malignancy in the past 10 years.
• Chronic use of opioids, anti-inflammatory drugs, antibiotics, prebiotics, or probiotics within 1 month of study endpoints
• History of a significant systemic condition (e.g., heart disease, chronic kidney disease, liver dysfunction or immune suppression), or abnormal laboratory markers (e.g., abnormal liver enzymes, creatinine, clotting factors, or low platelets count). The severity of the intolerance to fiber/ the medical conditions/lab markers and eligibility will be defined after the careful interview of the patient/review of the medical records by Dr. Hussan)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of California Davis — Sacramento

Идентификаторы

NCT: NCT06032104 · 2012455

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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