Obesity
Conditions
Keywords
Short Chain Fatty Acids, Propionate, Energy Expenditure, Lipid Oxidation
Brief 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.
Detailed description
Dietary fibres have long been recognised for their important role in a healthy diet due to their negative association with, and even management of, chronic diseases such as obesity, diabetes, metabolic syndrome, cardiovascular disease and inflammatory-bowel disease among others.Emerging evidence has suggested that these benefits could largely be attributed to short chain fatty acids (SCFA) (acetate, propionate and butyrate), the main by-products of fibre fermentation in the gut. Previous research has demonstrated that a long-term elevation in the SCFA propionate significantly reduced body weight gain in overweight adults and reduced liver fat storage. The current project will examine potential mechanisms for the positive effect of propionate on energy homeostasis and metabolic profile.The effects of propionate on circulating glucose, insulin, gut hormones and lipid levels at rest, following moderate-intensity exercise and mixed meal tolerance test will be examined. To acutely increase propionate absorption from the gut the present project will use a simple nutritional supplement: sodium propionate in a hydroxypropylmethyl cellulose (HPMC) capsule. This capsule is coated with an enteric film which prevents gastric digestion until the capsule reaches the intestine. This nutritional supplement has been used in human volunteers in a previously approved ethics application (12/LO/1769: Oral propionate and glucose homeostasis). A 5g acute dose of sodium propionate had previously been tested and reported no adverse effects . The MHRA have confirmed that encapsulated sodium propionate is not classed as an investigative medicinal product.
Interventions
Participant receive Placebo (Sodium Chloride)
OTHERExercise
1 hour exercise
DIETARY_SUPPLEMENTSodium Propionate
Participant receive Sodium Propionate
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators will be masked to the contents of the capsules (sodium propionate or sodium chloride). They will not be masked to whether it is a resting or exercise or fasting condition as this is not possible.
Intervention model description
This protocol consisted of three individual trials.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm) | 240 minutes | Changes in subjective hunger between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger. |
| Changes in Resting Lipid Oxidation | 6 hours | Changes in Resting Lipid Oxidation between sodium propionate and sodium chloride (control). |
| Changes in Energy Expenditure During Exercise | 240 minutes | Changes in Energy Expenditure between sodium propionate and sodium chloride (control) during exercise. |
| Changes in Energy Expenditure Post-prandially | 300 minutes | Changes in Energy Expenditure between sodium propionate and sodium chloride (control) post-prandially. |
| Changes in Lipid Oxidation Post-prandially | 300 minutes | Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) post-prandially. |
| Changes in Glucose Concentrations Post-prandially | 300 minutes | Changes in glucose concentrations between sodium propionate and sodium chloride (control) post-prandially. |
| Changes in Glucose Concentrations During Exercise | 240 minutes | Changes in glucose concentrations between sodium propionate and sodium chloride (control) during exercise. |
| Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm). | 300 minutes | Changes in subjective thirst between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst. |
| Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm) | 240 minutes | Changes in subjective thirst between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst. |
| Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm) | 240 minutes | Changes in subjective nausea between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea. |
| Changes in Lipid Oxidation During Exercise | 240 minutes | Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) during exercise. |
| Changes in Resting Energy Expenditure | 6 hours | Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in GLP-1 Concentration | 300 minutes | Changes in GLP-1 concentrations between sodium propionate and sodium chloride (control) post-prandially. |
| Changes in Insulin Concentration | 360 minutes | Changes in insulin concentrations between sodium propionate and sodium chloride (control) during fasting |
| Changes in Glucose Concentration | 360 minutes | Changes in glucose concentrations between sodium propionate and sodium chloride (control) during fasting |
| Changes in Subjective Nausea With Visual Analog Scales (100 mm) | 360 minutes | Changes in subjective nausea between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea. |
| Changes in Subjective Hunger With Visual Analog Scales (100 mm) | 360 minutes | Changes in subjective hunger between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger. |
| Changes in Subjective Thirst Using Visual Analog Scales (100 mm) | 360 minutes | Changes in subjective thirst between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst. |
| Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially | 300 minutes | Changes in subjective nausea between sodium propionate and sodium chloride (control) post-prandially. |
| Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm) | 300 minutes | Changes in subjective hunger between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger. |
| Changes in Free Fatty Acid Concentration | 360 minutes | Changes in free fatty acid concentrations between sodium propionate and sodium chloride (control) during fasting |
Countries
United Kingdom
Participant flow
Pre-assignment details
53 individual participants were enrolled in the entire study. 25 enrolled in Fasted Study (all new). 25 enrolled in Postprandial Study (16 new, 9 had previously enrolled in Fasted study). 25 enrolled in Exercise Study (12 new, 13 had previously enrolled in Fasted or Postprandial studies). The participant flow is therefore presented for the three individual study periods (25 starting each study period).
Participants by arm
| Arm | Count |
|---|---|
| Fasted Study Sodium Chloride tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes).
Placebo (Sodium Chloride): Participant receive Placebo (Sodium Chloride)
Theb
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes).
Sodium Propionate: Participant receive Sodium Propionate | 25 |
| Post-prandial Study Sodium Chloride tested in a post-prandial state. Participants will have the placebo then a mixed liquid meal test is given.
Placebo (Sodium Chloride): Participant receive Placebo (Sodium Chloride)
Then
Sodium Propionate tested in a post-prandial state. Participants will have the sodium propionate then a mixed liquid meal test is given. | 16 |
| Exercise Study Sodium Chloride tested in an exercise state. Participants will have the placebo then exercise will be performed at 40% of maximal aerobic capacity for one hour.
Placebo (Sodium Chloride): Participant receive Placebo (Sodium Chloride)
Exercise: 1 hour exercise
Then
Sodium Propionate tested in an exercise state. Participants will have the sodium propionate then exercise will be performed at 40% of maximal aerobic capacity for one hour.
Exercise: 1 hour exercise
Sodium Propionate: Participant receive Sodium Propionate | 12 |
| Total | 53 |
Baseline characteristics
| Characteristic | Fasted Study | Post-prandial Study | Exercise Study | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 16 Participants | 12 Participants | 53 Participants |
| BMI | 23.1 kg/m^2 STANDARD_DEVIATION 0.7 | 24.7 kg/m^2 STANDARD_DEVIATION 0.8 | 24.5 kg/m^2 STANDARD_DEVIATION 0.7 | 24.1 kg/m^2 STANDARD_DEVIATION 0.7 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 25 participants | 16 participants | 12 participants | 53 participants |
| Sex: Female, Male Female | 12 Participants | 7 Participants | 4 Participants | 23 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 8 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 20 |
Outcome results
Primary
Changes in Energy Expenditure During Exercise
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) during exercise.
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Energy Expenditure During Exercise | 5.085 kcal/min | Standard Deviation 0.33 |
| Propionate and Fasting | Changes in Energy Expenditure During Exercise | 4.991 kcal/min | Standard Deviation 0.328 |
Primary
Changes in Energy Expenditure Post-prandially
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) post-prandially.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Energy Expenditure Post-prandially | 1.057 kcal/min | Standard Deviation 0.044 |
| Propionate and Fasting | Changes in Energy Expenditure Post-prandially | 1.072 kcal/min | Standard Deviation 0.046 |
Primary
Changes in Glucose Concentrations During Exercise
Changes in glucose concentrations between sodium propionate and sodium chloride (control) during exercise.
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Glucose Concentrations During Exercise | 4.35 mmol/L | Standard Deviation 0.09 |
| Propionate and Fasting | Changes in Glucose Concentrations During Exercise | 4.47 mmol/L | Standard Deviation 0.07 |
Primary
Changes in Glucose Concentrations Post-prandially
Changes in glucose concentrations between sodium propionate and sodium chloride (control) post-prandially.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Glucose Concentrations Post-prandially | 5.38 mmol/L | Standard Deviation 0.133 |
| Propionate and Fasting | Changes in Glucose Concentrations Post-prandially | 5.40 mmol/L | Standard Deviation 0.141 |
Primary
Changes in Lipid Oxidation During Exercise
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) during exercise.
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Lipid Oxidation During Exercise | 0.284 g/min | Standard Deviation 0.032 |
| Propionate and Fasting | Changes in Lipid Oxidation During Exercise | 0.287 g/min | Standard Deviation 0.03 |
Primary
Changes in Lipid Oxidation Post-prandially
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) post-prandially.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Lipid Oxidation Post-prandially | 0.027 g/min | Standard Deviation 0.005 |
| Propionate and Fasting | Changes in Lipid Oxidation Post-prandially | 0.025 g/min | Standard Deviation 0.005 |
Primary
Changes in Resting Energy Expenditure
Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control).
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Resting Energy Expenditure | 1.013 kcal/min | Standard Deviation 0.034 |
| Propionate and Fasting | Changes in Resting Energy Expenditure | 1.040 kcal/min | Standard Deviation 0.039 |
Primary
Changes in Resting Lipid Oxidation
Changes in Resting Lipid Oxidation between sodium propionate and sodium chloride (control).
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Resting Lipid Oxidation | 0.032 g/min | Standard Deviation 0.007 |
| Propionate and Fasting | Changes in Resting Lipid Oxidation | 0.042 g/min | Standard Deviation 0.007 |
Primary
Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm)
Changes in subjective hunger between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm) | 51.7 mm | Standard Deviation 5.7 |
| Propionate and Fasting | Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm) | 57.2 mm | Standard Deviation 5.3 |
Primary
Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm)
Changes in subjective nausea between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea.
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm) | 2.9 mm | Standard Deviation 1.1 |
| Propionate and Fasting | Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm) | 6.7 mm | Standard Deviation 3.4 |
Primary
Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm)
Changes in subjective thirst between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm) | 39.8 mm | Standard Deviation 5.3 |
| Propionate and Fasting | Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm) | 46.8 mm | Standard Deviation 5.4 |
Primary
Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm).
Changes in subjective thirst between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm). | 15.7 mm | Standard Deviation 4.3 |
| Propionate and Fasting | Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm). | 14.5 mm | Standard Deviation 4 |
Secondary
Changes in Free Fatty Acid Concentration
Changes in free fatty acid concentrations between sodium propionate and sodium chloride (control) during fasting
Time frame: 360 minutes
Population: Data not yet analysed.
Secondary
Changes in GLP-1 Concentration
Changes in GLP-1 concentrations between sodium propionate and sodium chloride (control) post-prandially.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in GLP-1 Concentration | 67.9 mmol/L | Standard Deviation 7.1 |
| Propionate and Fasting | Changes in GLP-1 Concentration | 70.5 mmol/L | Standard Deviation 6.2 |
Secondary
Changes in Glucose Concentration
Changes in glucose concentrations between sodium propionate and sodium chloride (control) during fasting
Time frame: 360 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Glucose Concentration | 4.12 mmol/L | Standard Deviation 0.08 |
| Propionate and Fasting | Changes in Glucose Concentration | 4.14 mmol/L | Standard Deviation 0.08 |
Secondary
Changes in Insulin Concentration
Changes in insulin concentrations between sodium propionate and sodium chloride (control) post-prandially.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Insulin Concentration | 29.88 μU/mL | Standard Deviation 2.69 |
| Propionate and Fasting | Changes in Insulin Concentration | 30.27 μU/mL | Standard Deviation 2.17 |
Secondary
Changes in Insulin Concentration
Changes in insulin concentrations between sodium propionate and sodium chloride (control) during fasting
Time frame: 360 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Insulin Concentration | 7.70 μU/mL | Standard Deviation 0.48 |
| Propionate and Fasting | Changes in Insulin Concentration | 7.87 μU/mL | Standard Deviation 0.59 |
Secondary
Changes in Insulin Concentration
Changes in insulin concentrations between sodium propionate and sodium chloride (control) during exercise
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Insulin Concentration | 5.34 μU/mL | Standard Deviation 0.39 |
| Propionate and Fasting | Changes in Insulin Concentration | 5.63 μU/mL | Standard Deviation 0.55 |
Secondary
Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm)
Changes in subjective hunger between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm) | 48.8 mm | Standard Deviation 5 |
| Propionate and Fasting | Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm) | 43.7 mm | Standard Deviation 5.4 |
Secondary
Changes in Subjective Hunger With Visual Analog Scales (100 mm)
Changes in subjective hunger between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
Time frame: 360 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Hunger With Visual Analog Scales (100 mm) | 48.0 mm | Standard Deviation 4.11 |
| Propionate and Fasting | Changes in Subjective Hunger With Visual Analog Scales (100 mm) | 44.8 mm | Standard Deviation 5.25 |
Secondary
Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially
Changes in subjective nausea between sodium propionate and sodium chloride (control) post-prandially.
Time frame: 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially | 4.7 mm | Standard Deviation 1.8 |
| Propionate and Fasting | Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially | 5.3 mm | Standard Deviation 1.8 |
Secondary
Changes in Subjective Nausea With Visual Analog Scales (100 mm)
Changes in subjective nausea between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea.
Time frame: 360 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Nausea With Visual Analog Scales (100 mm) | 48.0 mm | Standard Deviation 4.11 |
| Propionate and Fasting | Changes in Subjective Nausea With Visual Analog Scales (100 mm) | 44.8 mm | Standard Deviation 5.25 |
Secondary
Changes in Subjective Thirst Using Visual Analog Scales (100 mm)
Changes in subjective thirst between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Time frame: 360 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Fasting | Changes in Subjective Thirst Using Visual Analog Scales (100 mm) | 24.7 mm | Standard Deviation 5.43 |
| Propionate and Fasting | Changes in Subjective Thirst Using Visual Analog Scales (100 mm) | 23.2 mm | Standard Deviation 5.25 |