Metabolic Effects of Short-Chain Fatty Acids in Healthy Individuals
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Propionate followed by Butyrate, Butyrate followed by Propionate, Propionate followed by Butyrate, Butyrate followed by Propionate.
- Кому может быть актуально
- Состояния в реестре: Healhty, Other: Short-Chain Fatty Acid (SCFA), Other: Butyrate (C4), Other: Propionate (C3). Базовые параметры: 18 лет — 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The primary objective of this study is to investigate the acute physiological and metabolic effects of ingesting the short-chain fatty acids (SCFA)s propionate (three carbon atoms long; C3:0) and butyrate (C4:0) in healthy men and women. This aim will be addressed through a block-randomized cross-over study including two visits with acute intake of propionate and butyrate, respectively. The hypothesis is that plasma ketone body levels will increase during the first three hours after intake of butyrate, but not propionate, in healthy individuals in the overnight fasted state.
Подробное описание
The study will be conducted as a block-randomized cross-over study in healty participants (n=10). The participants will undergo two experimental days of three hours separated by a two to four weeks wash-out period. At the test days, participants will consume 3 grams of either propionate or butyrate in the form of sodium-propionate or sodium-butyrate together with 250 ml of water. The order of ingestion is determined by randomization.
The day prior to the experimental days, participants will consume a standardized control dinner and evening snack and abstain from alcohol and vigorous physical activity to ensure similar conditions on the experimental days. The standardized meal will be provided to the participants. On the test days, participants will be instructed to arrive by passive transport in an overnight fasted state (10 hours). Upon arrival, a DXA scan will be performed, after which a catheter will be inserted into an antecubital vein. Following 30 minutes of supine rest, baseline measurements will be performed, including indirect calorimetry, blood pressure measurement, flow-mediated vasodilation (FMD), and a fasting venous blood sample. Participants will then ingest 3 grams of propionate or butyrate within 5 minutes, together with 250 ml of water. After ingestion, participants will remain resting in bed for 3 hours, during which blood samples (15 ml each) will be collected continuously throughout the test day. Indirect calorimetry, blood pressure measurements, and FMD will be repeated at various time points post-ingestion. The test day will end with an ad libitum meal. The entire procedure will be repeated on the second test day.
Вмешательства
- Другое Propionate followed by Butyrate
The participants will consume Short-chain fatty acid propionate (SCFA-PRO) followed by Short-Chain Fatty Acid Butyrate (SCFA-BUT). - Другое Butyrate followed by Propionate
• The participants will consume Short-chain fatty acid Butyrate (SCFA-BUT) followed by Short-Chain Fatty Acid Propionate (SCFA-PRO). - Другое Propionate followed by Butyrate
• The participants will consume Short-Chain Fatty Acid propionate (SCFA-PRO) followed by Short-Chain Fatty Acid Butyrate (SCFA-BUT). - Другое Butyrate followed by Propionate
The participants will consume Short-Chain Fatty Acid Butyrate (SCFA-BUT) followed by Short-Chain Fatty Acid Propionate (SCFA-PRO).
Первичные конечные точки
- Ketone Bodies [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).]
Вторичные конечные точки (10)
- Glucose [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).]
- Fatty acids [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).]
- Flow mediated dilation measurement [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (min 90).]
- Resting metabolic rate [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (30 min, 60 min, 120 min)]
- Respiratory exchange ratio [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (30 min, 60 min, 120 min)]
- Fatty Acid Composition [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).]
- Metabolites [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).]
- Hepatokines [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).]
- HOMA-Index [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).]
- Satiety [Срок оценки: On day 1 (test day 1) and day 2 (test day 2) at baseline (-15 min) and post intake (30 min, 60 min, 90 min and 120 min).]
Критерии участия
Критерии включения
- Male or female.
- Age between 18-40 years old
- BMI between 18.5-29
Критерии исключения
- Diabetes
- Kidney- or liver disease
- Pregnant, lactating or planning to become pregnant within the study period
- Supplementation with SCFAs
- Supplementation with B12 vitamin
- Special dietary habits (e.g. vegan/ketogenic diet)
- Ongoing cancer treatment
- Metabolic or absorptive disorders, gastric bypass operation, or use of medication affecting metabolism or food absorption
- Crohn's disease, ulcerative colitis or short bowel syndrome
- Inability, physically or mentally, to comply with the procedure required by the study protocol as evaluated by the primary investigator, study manager or clinical responsible
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
- Фундаментальное исследование
Центры проведения
Дания · 1 центр
- University of Copenhagen — Copenhagen
Идентификаторы
NCT: NCT07183488 · H-25038908