The Acute Effect of Propionate on Energy Homeostasis (PROEM)

Imperial College London

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Sodium Propionate; Other: Placebo (Sodium Chloride); Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04093453

18hh4373

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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53 participants in 6 patient groups, including a placebo group

Placebo + Fasting

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo (Sodium Chloride)

Placebo + Exercise

Placebo Comparator group

Description:

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.

Treatment:

Other: Exercise

Other: Placebo (Sodium Chloride)

Placebo + Post-prandial

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo (Sodium Chloride)

Propionate and Fasting

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sodium Propionate

Propionate and Exercise

Experimental group

Description:

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.

Treatment:

Other: Exercise

Dietary Supplement: Sodium Propionate

Propionate and Post-prandial

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sodium Propionate