Butyrate/Hexanoate in Metabolic Health

Butyrate/Hexanoate-enriched Triglycerides for 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.

Study Overview

• Status: Completed
• Conditions: Metabolic Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: butyrate and hexanoate amount 1; Dietary supplement: butyrate and hexanoate amount 2; Dietary supplement: butyrate and hexanoate amount 3

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; acute intake of 0 mg butyrate and hexanoate
EXPERIMENTAL: butyrate and hexanoate amount 1; 1325 mg of butyrate and hexanoate	Dietary supplement: butyrate and hexanoate amount 1; acute intake of 650 mg butyrate and hexanoate
EXPERIMENTAL: butyrate and hexanoate amount 2	Dietary supplement: butyrate and hexanoate amount 2; acute intake of 1325 mg butyrate and hexanoate
EXPERIMENTAL: butyrate and hexanoate amount 3	Dietary supplement: butyrate and hexanoate amount 3; acute intake of 2000 mg butyrate and hexanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma butyrate concentrations	Plasma butyrate concentrations	Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating Glucose	Circulating Glucose assessed in plasma	Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement
Circulating Free Fatty Acids	Circulating Free Fatty Acids assessed in plasma	Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement
Circulating Glycerol	Circulating Glycerol assessed in plasma	Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement
Circulating Triglycerides (TG)	Circulating Triglycerides assessed in plasma	Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement
Circulating insulin	Circulating . insulin will be assessed in plasma	Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement
Breath H2	Breath H2 using Gastrolyzer	Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2021
• Primary Completion (ACTUAL): July 26, 2021
• Study Completion (ACTUAL): July 26, 2021

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: NL75253.068.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No