Trial Outcomes & Findings for The Acute Effect of Propionate on Energy Homeostasis (NCT NCT04093453)

NCT ID: NCT04093453

Last Updated: 2024-08-23

Results Overview

Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

6 hours

Results posted on

2024-08-23

Participant Flow

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).

Participant milestones

Participant milestones
Measure
Fasted Study: Placebo/Propionate
Sodium Chloride tested in a fasted state. Participants will be fasting for duration of study visit (360 minutes). Placebo (Sodium Chloride): Participant receive Placebo (Sodium Chloride) then Sodium Propionate tested in a fasted state. Participants will be fasting for duration of study visit (360 minutes). Propionate (Sodium Propionate): Participant receive Propionate (Sodium Propionate)
Fasted Study: Propionate/Placebo
Sodium Propionate tested in a fasted state. Participants will be fasting for duration of study visit (360 minutes). Propionate (Sodium Propionate): Participant receive Propionate (Sodium Propionate) then Sodium Chloride tested in a fasted state. Participants will be fasting for duration of study visit (360 minutes). Placebo (Sodium Chloride): Participant receive Placebo (Sodium Chloride)
Post-Prandial Study: Placebo/Propionate
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 Propionate then a mixed liquid meal test is given. Propionate (Sodium Propionate): Participant receive Propionate (Sodium Propionate)
Post-Prandial Study: Propionate/Placebo
Sodium Propionate tested in a post-prandial state. Participants will have the Propionate then a mixed liquid meal test is given. Propionate (Sodium Propionate): Participant receive Propionate (Sodium Propionate) then 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)
Exercise Study: Placebo/Propionate
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 Propionate then exercise will be performed at 40% of maximal aerobic capacity for one hour. Propionate (Sodium Propionate): Participant receive Propionate (Sodium Propionate) Exercise: 1 hour exercise
Exercise Study: Propionate/Placebo
Sodium Propionate tested in an exercise state. Participants will have the Propionate then exercise will be performed at 40% of maximal aerobic capacity for one hour. Propionate (Sodium Propionate): Participant receive Propionate (Sodium Propionate) Exercise: 1 hour exercise then 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
Fasted Study
STARTED
12
13
0
0
0
0
Fasted Study
COMPLETED
10
9
0
0
0
0
Fasted Study
NOT COMPLETED
2
4
0
0
0
0
Postprandial Study
STARTED
0
0
12
13
0
0
Postprandial Study
COMPLETED
0
0
9
11
0
0
Postprandial Study
NOT COMPLETED
0
0
3
2
0
0
Exercise Study
STARTED
0
0
0
0
13
12
Exercise Study
COMPLETED
0
0
0
0
10
9
Exercise Study
NOT COMPLETED
0
0
0
0
3
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fasted Study
n=25 Participants
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
Post-prandial Study
n=16 Participants
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.
Exercise Study
n=12 Participants
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
Total
n=53 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=25 Participants
0 Participants
n=16 Participants
0 Participants
n=12 Participants
0 Participants
n=53 Participants
Age, Categorical
Between 18 and 65 years
25 Participants
n=25 Participants
16 Participants
n=16 Participants
12 Participants
n=12 Participants
53 Participants
n=53 Participants
Age, Categorical
>=65 years
0 Participants
n=25 Participants
0 Participants
n=16 Participants
0 Participants
n=12 Participants
0 Participants
n=53 Participants
Sex: Female, Male
Female
12 Participants
n=25 Participants
7 Participants
n=16 Participants
4 Participants
n=12 Participants
23 Participants
n=53 Participants
Sex: Female, Male
Male
13 Participants
n=25 Participants
9 Participants
n=16 Participants
8 Participants
n=12 Participants
30 Participants
n=53 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United Kingdom
25 participants
n=25 Participants
16 participants
n=16 Participants
12 participants
n=12 Participants
53 participants
n=53 Participants
BMI
23.1 kg/m^2
STANDARD_DEVIATION 0.7 • n=25 Participants
24.7 kg/m^2
STANDARD_DEVIATION 0.8 • n=16 Participants
24.5 kg/m^2
STANDARD_DEVIATION 0.7 • n=12 Participants
24.1 kg/m^2
STANDARD_DEVIATION 0.7 • n=53 Participants

PRIMARY outcome

Timeframe: 6 hours

Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control).

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Resting Energy Expenditure
1.013 kcal/min
Standard Deviation 0.034
1.040 kcal/min
Standard Deviation 0.039

PRIMARY outcome

Timeframe: 6 hours

Changes in Resting Lipid Oxidation between sodium propionate and sodium chloride (control).

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Resting Lipid Oxidation
0.032 g/min
Standard Deviation 0.007
0.042 g/min
Standard Deviation 0.007

PRIMARY outcome

Timeframe: 240 minutes

Changes in Energy Expenditure between sodium propionate and sodium chloride (control) during exercise.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Energy Expenditure During Exercise
5.085 kcal/min
Standard Deviation 0.330
4.991 kcal/min
Standard Deviation 0.328

PRIMARY outcome

Timeframe: 240 minutes

Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) during exercise.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Lipid Oxidation During Exercise
0.284 g/min
Standard Deviation 0.032
0.287 g/min
Standard Deviation 0.030

PRIMARY outcome

Timeframe: 300 minutes

Changes in Energy Expenditure between sodium propionate and sodium chloride (control) post-prandially.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Energy Expenditure Post-prandially
1.057 kcal/min
Standard Deviation 0.044
1.072 kcal/min
Standard Deviation 0.046

PRIMARY outcome

Timeframe: 300 minutes

Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) post-prandially.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Lipid Oxidation Post-prandially
0.027 g/min
Standard Deviation 0.005
0.025 g/min
Standard Deviation 0.005

PRIMARY outcome

Timeframe: 300 minutes

Changes in glucose concentrations between sodium propionate and sodium chloride (control) post-prandially.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Glucose Concentrations Post-prandially
5.38 mmol/L
Standard Deviation 0.133
5.40 mmol/L
Standard Deviation 0.141

PRIMARY outcome

Timeframe: 240 minutes

Changes in glucose concentrations between sodium propionate and sodium chloride (control) during exercise.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Glucose Concentrations During Exercise
4.35 mmol/L
Standard Deviation 0.09
4.47 mmol/L
Standard Deviation 0.07

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm).
15.7 mm
Standard Deviation 4.3
14.5 mm
Standard Deviation 4.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm)
39.8 mm
Standard Deviation 5.3
46.8 mm
Standard Deviation 5.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm)
2.9 mm
Standard Deviation 1.1
6.7 mm
Standard Deviation 3.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm)
51.7 mm
Standard Deviation 5.7
57.2 mm
Standard Deviation 5.3

SECONDARY outcome

Timeframe: 300 minutes

Changes in GLP-1 concentrations between sodium propionate and sodium chloride (control) post-prandially.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in GLP-1 Concentration
67.9 mmol/L
Standard Deviation 7.1
70.5 mmol/L
Standard Deviation 6.2

SECONDARY outcome

Timeframe: 360 minutes

Changes in insulin concentrations between sodium propionate and sodium chloride (control) during fasting

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Insulin Concentration
7.70 μU/mL
Standard Deviation 0.48
7.87 μU/mL
Standard Deviation 0.59

SECONDARY outcome

Timeframe: 360 minutes

Changes in glucose concentrations between sodium propionate and sodium chloride (control) during fasting

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Glucose Concentration
4.12 mmol/L
Standard Deviation 0.08
4.14 mmol/L
Standard Deviation 0.08

SECONDARY outcome

Timeframe: 360 minutes

Population: Data not yet analysed.

Changes in free fatty acid concentrations between sodium propionate and sodium chloride (control) during fasting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Nausea With Visual Analog Scales (100 mm)
48.0 mm
Standard Deviation 4.11
44.8 mm
Standard Deviation 5.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Hunger With Visual Analog Scales (100 mm)
48.0 mm
Standard Deviation 4.11
44.8 mm
Standard Deviation 5.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Thirst Using Visual Analog Scales (100 mm)
24.7 mm
Standard Deviation 5.43
23.2 mm
Standard Deviation 5.25

SECONDARY outcome

Timeframe: 240 minutes

Changes in insulin concentrations between sodium propionate and sodium chloride (control) during exercise

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=19 Participants
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)
Propionate and Fasting
n=19 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Insulin Concentration
5.34 μU/mL
Standard Deviation 0.39
5.63 μU/mL
Standard Deviation 0.55

SECONDARY outcome

Timeframe: 300 minutes

Changes in insulin concentrations between sodium propionate and sodium chloride (control) post-prandially.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Insulin Concentration
29.88 μU/mL
Standard Deviation 2.69
30.27 μU/mL
Standard Deviation 2.17

SECONDARY outcome

Timeframe: 300 minutes

Changes in subjective nausea between sodium propionate and sodium chloride (control) post-prandially.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially
4.7 mm
Standard Deviation 1.8
5.3 mm
Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo + Fasting
n=20 Participants
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)
Propionate and Fasting
n=20 Participants
Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Sodium Propionate: Participant receive Sodium Propionate
Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm)
48.8 mm
Standard Deviation 5.0
43.7 mm
Standard Deviation 5.4

Adverse Events

Placebo + Fasting Then Propionate and Fasting

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo + Exercise Then Propionate and Exercise

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo + Postprandial Then Propionate and Postprandial

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Edward Chambers

Imperial College London

Phone: +44 20 7594 0959

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place