跳至主要内容
临床试验/NCT07183488
NCT07183488招募中不适用

Metabolic Effects of Short-Chain Fatty Acids in Healthy Individuals

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年9月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Ketone Bodies

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female.
  • Age between 18-40 years old
  • BMI between 18.5-29

排除标准

  • 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

研究组 & 干预措施

Female

Experimental

干预措施: Propionate followed by Butyrate (Other)

Female

Experimental

干预措施: Butyrate followed by Propionate (Other)

Male

Experimental

干预措施: Propionate followed by Butyrate (Other)

Male

Experimental

干预措施: Butyrate followed by Propionate (Other)

结局指标

主要结局

Ketone Bodies

时间窗: 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).

To measure the effect of Short-Chain Fatty Acid Butyrate (SCFA-BUT) and Short-Chain Fatty Acid Propionate (SCFA-PRO) on circulating ketone body concentrations.

次要结局

  • Glucose(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(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(On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (min 90).)
  • Resting metabolic rate(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(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(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(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).)
  • Metabolites(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(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(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).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验