Skip to main content
OpenTrials
Completed

NCT Number: NCT04662411

Butyrate/Hexanoate in Metabolic Health

In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be further used for a long-term study.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overweight/obese men (BMI ≥ 25 kg/m2 and ≤ 34.9 kg/m2);
  • Aged 40 - 70 years;
  • Caucasian;
  • Normal blood pressure (systolic blood pressure 100-140mmHg, diastolic blood pressure 60-90 mmHg);
  • Weight stable for at least 3 months (± 2 kg).

Exclusion criteria

  • Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L)
  • Gastroenterological diseases or abdominal surgery (gallbladder removal and appendix removal are allowed)
  • Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
  • Lactose intolerance or other disorders that affect digestion (such as celiac disease)
  • Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day; and excessive alcohol use defined as (> 15 units/week)
  • Plans to lose weight or following of a hypocaloric diet in the following three months;
  • Regular supplementation of pre- or probiotic products (for example Yakult, Activia), use of pre- or probiotics 3 months prior to the start of the study;
  • Intensive exercise training more than three hours a week;
  • Use of any medication that influences glucose or fat metabolism and inflammation (i.e. betablockers, corticosteroids, statins or NSAIDs);
  • Regular use of laxation products in 3 months prior start of study or during study period;
  • Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
  • Follow a vegan diet or vegetarian diet.

Treatment and study plan

Placebo

Dietary Supplement

acute intake of 0 mg butyrate and hexanoate

butyrate and hexanoate amount 1

Dietary Supplement

acute intake of 650 mg butyrate and hexanoate

butyrate and hexanoate amount 2

Dietary Supplement

acute intake of 1325 mg butyrate and hexanoate

butyrate and hexanoate amount 3

Dietary Supplement

acute intake of 2000 mg butyrate and hexanoate

Primary outcomes

  1. Plasma butyrate concentrations

    Time frame: Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement

    Plasma butyrate concentrations

Secondary outcomes

  1. Circulating Glucose

    Time frame: Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement

    Circulating Glucose assessed in plasma

  2. Circulating Free Fatty Acids

    Time frame: Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement

    Circulating Free Fatty Acids assessed in plasma

  3. Circulating Glycerol

    Time frame: Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement

    Circulating Glycerol assessed in plasma

  4. Circulating Triglycerides (TG)

    Time frame: Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement

    Circulating Triglycerides assessed in plasma

  5. Circulating insulin

    Time frame: Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement

    Circulating . insulin will be assessed in plasma

  6. Breath H2

    Time frame: Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement

    Breath H2 using Gastrolyzer

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2020
Registry last updated
Nov 29, 2021

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.

Published trials that share one or more normalized conditions with this study.