Danish Pulses Meal Study

Официальное название

Danish Pulses: Tasty, Healthy, and Safe Danish Pulses With Added Value for The Users

Обзор

The goal of this clinical trial is to learn whether daily intake of lactic acid bacteria fermented or unfermented legumes can improve metabolic and gut health in healthy adults. The main questions it aims to answer are: * Does eating 100 g per day of legumes for 2 weeks lower blood glucose, measured primarily by continuous glucose monitoring, compared with a control period of habitual diet? * Does eating 100 g per day of legumes for 2 weeks improve inflammation, cholesterol, gut microbiome composition, and short-chain fatty acid (SCFA) levels, and do fermented legumes have additional effects on body composition compared with unfermented legumes? Researchers will compare participants consuming LAB-fermented legumes with participants consuming unfermented legumes to see if fermented legumes produce greater health benefits, particularly for body composition and other metabolic outcomes. Participants will: * Follow their habitual diet for 14 days during a control period. * Complete baseline measurements after the control period. * Be randomly assigned to consume 100 g per day of either LAB-fermented or unfermented legumes for 14 days. * Eat the provided standardized legume foods as part of their usual meals. * Undergo continuous glucose monitoring and other assessments, incl. inflammation, cholesterol, long-term blood glucose, blood pressure, body composition, fecal microbiome, dietary intake, and digestive symptoms.

Вмешательства

• Пищевая добавка Pulses meal study
  The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period) followed by the second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of lactic acid fermented pulses every day, seven days a week, for two weeks. Fermented pulses will be provided and packed as standardized food items to their habitual meals e.g. as hummus, or pasta with legume
• Пищевая добавка Pulses Meal Study
  The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period) followed by the second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of unfermented pulses every day, seven days a week, for two weeks. The unfermented pulses will be provided and packed as standardized food items to their habitual meals e.g. as hummus, or pasta with legume flou

Первичные конечные точки

• Continuous glucose monitoring [Срок оценки: From day zero to 14 days and from day 14 to day 28]

Вторичные конечные точки (8)

• Inflammation CRP level [Срок оценки: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).]
• Fasting Cholesterol [Срок оценки: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).]
• Long-term blood glucose [Срок оценки: Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).]
• Blood pressure [Срок оценки: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).]
• Body composition [Срок оценки: Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).]
• Fecal sample [Срок оценки: Three measurements: at baseline (day 0), follow up 1 (day 14), and at follow up 2 (day 28).]
• Dietary intake [Срок оценки: Three measurements: at baseline (day 0), follow-up 1 (day 14) and follow-ip 2 (day 28).]
• Digestive abnormalities [Срок оценки: Three measurements: at baseline (day 0) , follow-up 1 (day 14), and at follow-up 2 (day 28).]

Критерии участия

Критерии включения

• No diabetes

Критерии исключения

• Treatment with antibiotics within the last three months.
• Ongoing treatment with non-steroidal anti-inflammatory drugs.
• Metabolic diseases, including diabetes.
• Inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis.
• Allergies or intolerance to legumes.
• People that report eating > 25 g per day of legumes as part of their habitual diet.

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

Открытое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• University College Absalon — Slagelse

Идентификаторы

NCT: NCT07574008 · SJ-1132-120770 · 34009-23-2191

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗