Propionate and Energy Homeostasis

Obesity Clinical Trial

— PROEM  

Official title:

The Acute Effect of Propionate on Energy Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093453
• Other study ID #: 18hh4373
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: August 7, 2019

Study information

• Verified date: October 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Placebo (Sodium Chloride)
Participant receive Placebo (Sodium Chloride)
• Exercise
1 hour exercise

Dietary Supplement:
• Sodium Propionate
Participant receive Sodium Propionate

Locations

Country	Name	City	State
United Kingdom	Imperial Clinical Research Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Resting Energy Expenditure	Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control).	6 hours
Primary	Changes in Resting Lipid Oxidation	Changes in Resting Lipid Oxidation between sodium propionate and sodium chloride (control).	6 hours
Primary	Changes in Energy Expenditure during Exercise	Changes in Energy Expenditure between sodium propionate and sodium chloride (control) during exercise.	240 minutes
Primary	Changes in Lipid Oxidation during Exercise	Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) during exercise.	240 minutes
Primary	Changes in Energy Expenditure post-prandially	Changes in Energy Expenditure between sodium propionate and sodium chloride (control) post-prandially.	300 minutes
Primary	Changes in Lipid Oxidation post-prandially	Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) post-prandially.	300 minutes
Secondary	Changes in GLP-1 Concentration	Changes in GLP-1 concentrations between sodium propionate and sodium chloride (control) during fasting, exercise and post-prandially.	360, 240 and 300 minutes
Secondary	Changes in Insulin Concentration	Changes in insulin concentrations between sodium propionate and sodium chloride (control) during fasting, exercise and post-prandially.	360, 240 and 300 minutes
Secondary	Changes in glucose concentration	Changes in glucose concentrations between sodium propionate and sodium chloride (control) during fasting, exercise and post-prandially.	360, 240 and 300 minutes
Secondary	Changes in free fatty acid concentration	Changes in free fatty acid concentrations between sodium propionate and sodium chloride (control) during fasting, exercise and post-prandially.	360, 240 and 300 minutes
Secondary	Changes in subjective nausea	Changes in subjective nausea between sodium propionate and sodium chloride (control) during fasting, exercise and post-prandially.	360, 240 and 300 minutes
Secondary	Changes in subjective hunger	Changes in subjective hunger between sodium propionate and sodium chloride (control) during fasting, exercise and post-prandially.	360, 240 and 300 minutes
Secondary	Changes in subjective thirst	Changes in subjective thirst between sodium propionate and sodium chloride (control) during fasting, exercise and post-prandially.	360, 240 and 300 minutes