N/A
Completed N=25
The Acute Effect of Propionate on Energy Homeostasis
Source: ClinicalTrials.gov NCT04093453 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Changes in Resting Energy Expenditure — 1.013; 1.040 kcal/min
Summary
The research project aims to examine the effect of a dietary supplement called propionate on how the human body in healthy adults aged (18- 65 years) responds to during fasting, exercise and following a liquid mixed meal test and how that would affect energy homeostasis and substrate oxidation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Resting Energy Expenditure |
1.013; 1.040 | — |
| PRIMARY Changes in Resting Lipid Oxidation |
0.032; 0.042 | — |
| PRIMARY Changes in Energy Expenditure During Exercise |
5.085; 4.991 | — |
| PRIMARY Changes in Lipid Oxidation During Exercise |
0.284; 0.287 | — |
| PRIMARY Changes in Energy Expenditure Post-prandially |
1.057; 1.072 | — |
| PRIMARY Changes in Lipid Oxidation Post-prandially |
0.027; 0.025 | — |
| PRIMARY Changes in Glucose Concentrations Post-prandially |
5.38; 5.40 | — |
| PRIMARY Changes in Glucose Concentrations During Exercise |
4.35; 4.47 | — |
| PRIMARY Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm). |
15.7; 14.5 | — |
| PRIMARY Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm) |
39.8; 46.8 | — |
| PRIMARY Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm) |
2.9; 6.7 | — |
| PRIMARY Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm) |
51.7; 57.2 | — |
| SECONDARY Changes in GLP-1 Concentration |
67.9; 70.5 | — |
| SECONDARY Changes in Insulin Concentration |
29.88; 30.27 | — |
| SECONDARY Changes in Glucose Concentration |
4.12; 4.14 | — |
| SECONDARY Changes in Free Fatty Acid Concentration |
— | — |
| SECONDARY Changes in Subjective Nausea With Visual Analog Scales (100 mm) |
48.0; 44.8 | — |
| SECONDARY Changes in Subjective Hunger With Visual Analog Scales (100 mm) |
48.0; 44.8 | — |
| SECONDARY Changes in Subjective Thirst Using Visual Analog Scales (100 mm) |
24.7; 23.2 | — |
| SECONDARY Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially |
4.7; 5.3 | — |
| SECONDARY Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm) |
48.8; 43.7 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers (body mass index (BMI) of 18-35 kg/m2)
- Age between 18-65 years (inclusive)
Exclusion Criteria
- Weight change of ≥ 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
- Diabetes
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
- Involved in current research or have recently been involved in any research prior to recruitment in the past 12 weeks.
Data sourced from ClinicalTrials.gov (NCT04093453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.