Metabolic Effects of Short-Chain Fatty Acids in Healthy Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propionate followed by Butyrate, Butyrate followed by Propionate, Propionate followed by Butyrate, Butyrate followed by Propionate.
- Who it may be relevant to
- Registry conditions: Healhty, Other: Short-Chain Fatty Acid (SCFA), Other: Butyrate (C4), Other: Propionate (C3). Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other Propionate followed by Butyrate
The participants will consume Short-chain fatty acid propionate (SCFA-PRO) followed by Short-Chain Fatty Acid Butyrate (SCFA-BUT). - Other Butyrate followed by Propionate
• The participants will consume Short-chain fatty acid Butyrate (SCFA-BUT) followed by Short-Chain Fatty Acid Propionate (SCFA-PRO). - Other Propionate followed by Butyrate
• The participants will consume Short-Chain Fatty Acid propionate (SCFA-PRO) followed by Short-Chain Fatty Acid Butyrate (SCFA-BUT). - Other Butyrate followed by Propionate
The participants will consume Short-Chain Fatty Acid Butyrate (SCFA-BUT) followed by Short-Chain Fatty Acid Propionate (SCFA-PRO).
Primary outcome measures
- Ketone Bodies [Time frame: 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).]
Secondary outcome measures (10)
- Glucose [Time frame: 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 [Time frame: 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 [Time frame: On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (min 90).]
- Resting metabolic rate [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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).]
Eligibility criteria
Inclusion criteria
- Male or female.
- Age between 18-40 years old
- BMI between 18.5-29
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- University of Copenhagen — Copenhagen
Identifiers
NCT: NCT07183488 · H-25038908