The Acute Effect of Propionate on Energy Homeostasis

Imperial College London53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

Placebo (Sodium Chloride)OTHER

Participant receive Placebo (Sodium Chloride)

ExerciseOTHER

1 hour exercise

Sodium PropionateDIETARY_SUPPLEMENT

Participant receive Sodium Propionate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Imperial Clinical Research Facility

London, United Kingdom

Outcomes

Primary Outcomes

Changes in Resting Energy Expenditure

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

Time frame: 6 hours

Changes in Resting Lipid Oxidation

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

Time frame: 6 hours

Changes in Energy Expenditure During Exercise

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

Time frame: 240 minutes

Changes in Lipid Oxidation During Exercise

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

Time frame: 240 minutes

Changes in Energy Expenditure Post-prandially

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

Time frame: 300 minutes

Changes in Lipid Oxidation Post-prandially

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

Time frame: 300 minutes

Changes in Glucose Concentrations Post-prandially

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

Time frame: 300 minutes

Changes in Glucose Concentrations During Exercise

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Changes in GLP-1 Concentration

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

Time frame: 300 minutes

Changes in Insulin Concentration

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

Time frame: 360 minutes

Changes in Glucose Concentration

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

Time frame: 360 minutes

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

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

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

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

Changes in Insulin Concentration

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

Time frame: 240 minutes

Changes in Insulin Concentration

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

Time frame: 300 minutes

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

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