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Completed

NCT Number: NCT04093453

The Acute Effect of Propionate on Energy Homeostasis

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo (Sodium Chloride)

Other

Participant receive Placebo (Sodium Chloride)

Exercise

Other

1 hour exercise

Sodium propionate

Dietary Supplement

Participant receive Sodium Propionate

Primary outcomes

  1. Changes in Resting Energy Expenditure

    Time frame: 6 hours

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

  2. Changes in Resting Lipid Oxidation

    Time frame: 6 hours

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

  3. Changes in Energy Expenditure During Exercise

    Time frame: 240 minutes

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

  4. Changes in Lipid Oxidation During Exercise

    Time frame: 240 minutes

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

  5. Changes in Energy Expenditure Post-prandially

    Time frame: 300 minutes

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

  6. Changes in Lipid Oxidation Post-prandially

    Time frame: 300 minutes

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

  7. Changes in Glucose Concentrations Post-prandially

    Time frame: 300 minutes

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

  8. Changes in Glucose Concentrations During Exercise

    Time frame: 240 minutes

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

  9. Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm).

    Time frame: 300 minutes

    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.

  10. Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm)

    Time frame: 240 minutes

    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.

  11. Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm)

    Time frame: 240 minutes

    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.

  12. Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm)

    Time frame: 240 minutes

    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.

Secondary outcomes

  1. Changes in GLP-1 Concentration

    Time frame: 300 minutes

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

  2. Changes in Insulin Concentration

    Time frame: 360 minutes

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

  3. Changes in Glucose Concentration

    Time frame: 360 minutes

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

  4. Changes in Free Fatty Acid Concentration

    Time frame: 360 minutes

    Changes in free fatty acid concentrations between sodium propionate and sodium chloride (control) during fasting

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

    Time frame: 360 minutes

    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.

  6. Changes in Subjective Hunger With Visual Analog Scales (100 mm)

    Time frame: 360 minutes

    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.

  7. Changes in Subjective Thirst Using Visual Analog Scales (100 mm)

    Time frame: 360 minutes

    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.

  8. Changes in Insulin Concentration

    Time frame: 240 minutes

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

  9. Changes in Insulin Concentration

    Time frame: 300 minutes

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

  10. Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially

    Time frame: 300 minutes

    Changes in subjective nausea between sodium propionate and sodium chloride (control) post-prandially.

  11. Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm)

    Time frame: 300 minutes

    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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: PROEM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2019
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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