Butyrate/Hexanoate in Metabolic Health

Metabolic Disease Clinical Trial

Official title:

Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662411
• Other study ID #: NL75253.068.20
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: July 26, 2021

Study information

• Verified date: November 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases

Intervention

Dietary Supplement:
• Placebo
acute intake of 0 mg butyrate and hexanoate
• butyrate and hexanoate amount 1
acute intake of 650 mg butyrate and hexanoate
• butyrate and hexanoate amount 2
acute intake of 1325 mg butyrate and hexanoate
• butyrate and hexanoate amount 3
acute intake of 2000 mg butyrate and hexanoate

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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