The Acute Effect of Propionate on Energy Homeostasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2019-08-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This protocol consisted of three individual trials.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Placebo + Fasting

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

Group Type PLACEBO_COMPARATOR

Placebo (Sodium Chloride)

Intervention Type OTHER

Participant receive Placebo (Sodium Chloride)

Placebo + Exercise

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.

Group Type PLACEBO_COMPARATOR

Placebo (Sodium Chloride)

Intervention Type OTHER

Participant receive Placebo (Sodium Chloride)

Exercise

Intervention Type OTHER

1 hour exercise

Placebo + Post-prandial

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

Group Type PLACEBO_COMPARATOR

Placebo (Sodium Chloride)

Intervention Type OTHER

Participant receive Placebo (Sodium Chloride)

Propionate and Fasting

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

Group Type EXPERIMENTAL

Sodium Propionate

Intervention Type DIETARY_SUPPLEMENT

Participant receive Sodium Propionate

Propionate and Exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

1 hour exercise

Sodium Propionate

Intervention Type DIETARY_SUPPLEMENT

Participant receive Sodium Propionate

Propionate and Post-prandial

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

Group Type EXPERIMENTAL

Sodium Propionate

Intervention Type DIETARY_SUPPLEMENT

Participant receive Sodium Propionate

Interventions

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Placebo (Sodium Chloride)

Participant receive Placebo (Sodium Chloride)

Intervention Type OTHER

Exercise

1 hour exercise

Intervention Type OTHER

Sodium Propionate

Participant receive Sodium Propionate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes