The Acute Effect of Propionate on Energy Homeostasis

NCT04093453 | Completed Results

• 1 other identifier: 18hh4373
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Short Chain Fatty Acids; Propionate; Energy Expenditure; Lipid Oxidation

Outcome Measures

Primary Outcomes (12)

• Changes in Resting Energy Expenditure

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

  6 hours

• Changes in Resting Lipid Oxidation

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

  6 hours

• Changes in Energy Expenditure During Exercise

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

  240 minutes

• Changes in Lipid Oxidation During Exercise

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

  240 minutes

• Changes in Energy Expenditure Post-prandially

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

  300 minutes

• Changes in Lipid Oxidation Post-prandially

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

  300 minutes

• Changes in Glucose Concentrations Post-prandially

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

  300 minutes

• Changes in Glucose Concentrations During Exercise

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

  240 minutes

• 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.

  300 minutes

• 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.

  240 minutes

• 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.

  240 minutes

• 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.

  240 minutes

Secondary Outcomes (11)

• Changes in GLP-1 Concentration

  300 minutes

• Changes in Insulin Concentration

  360 minutes

• Changes in Glucose Concentration

  360 minutes

• Changes in Free Fatty Acid Concentration

  360 minutes

• Changes in Subjective Nausea With Visual Analog Scales (100 mm)

  360 minutes

Study Arms (6)

Placebo + Fasting

PLACEBO COMPARATOR

Sodium Chloride tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes).

Other: Placebo (Sodium Chloride)

Placebo + Exercise

PLACEBO COMPARATOR

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.

Other: Placebo (Sodium Chloride); Other: Exercise

Placebo + Post-prandial

PLACEBO COMPARATOR

Sodium Chloride tested in a post-prandial state. Participants will have the placebo then a mixed liquid meal test is given.

Other: Placebo (Sodium Chloride)

Propionate and Fasting

EXPERIMENTAL

Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes).

Dietary Supplement: Sodium Propionate

Propionate and Exercise

EXPERIMENTAL

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.

Other: Exercise; Dietary Supplement: Sodium Propionate

Propionate and Post-prandial

EXPERIMENTAL

Sodium Propionate tested in a post-prandial state. Participants will have the sodium propionate then a mixed liquid meal test is given.

Dietary Supplement: Sodium Propionate

Interventions

Placebo (Sodium Chloride) OTHER

Participant receive Placebo (Sodium Chloride)

Placebo + Exercise; Placebo + Fasting; Placebo + Post-prandial

Exercise OTHER

1 hour exercise

Placebo + Exercise; Propionate and Exercise

Sodium Propionate DIETARY_SUPPLEMENT

Participant receive Sodium Propionate

Propionate and Exercise; Propionate and Fasting; Propionate and Post-prandial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers (body mass index (BMI) of 18-35 kg/m2)
• Age between 18-65 years (inclusive)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Sodium Chloride; Exercise; sodium propionate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Edward Chambers
• Organization: Imperial College London

e.chambers@imperial.ac.uk

+44 20 7594 0959

Study Officials

• Edward Chambers, PhD

  Imperial College London

  STUDY DIRECTOR

• Gary Frost, Professor

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This protocol consisted of three individual trials.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: September 18, 2019
• Study Start: February 12, 2018
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)