Butyrate/Hexanoate in Metabolic Health

NCT04662411 | Completed DMC

• 1 other identifier: NL75253.068.20
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Circulating Glucose

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

• Circulating Free Fatty Acids

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

• Circulating Glycerol

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

• Circulating Triglycerides (TG)

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

• Circulating insulin

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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

butyrate and hexanoate amount 1

EXPERIMENTAL

1325 mg of butyrate and hexanoate

Dietary Supplement: butyrate and hexanoate amount 1

butyrate and hexanoate amount 2

EXPERIMENTAL

Dietary Supplement: butyrate and hexanoate amount 2

butyrate and hexanoate amount 3

EXPERIMENTAL

Dietary Supplement: butyrate and hexanoate amount 3

Interventions

Placebo DIETARY_SUPPLEMENT

acute intake of 0 mg butyrate and hexanoate

Placebo

butyrate and hexanoate amount 1 DIETARY_SUPPLEMENT

acute intake of 650 mg butyrate and hexanoate

butyrate and hexanoate amount 1

butyrate and hexanoate amount 2 DIETARY_SUPPLEMENT

acute intake of 1325 mg butyrate and hexanoate

butyrate and hexanoate amount 2

butyrate and hexanoate amount 3 DIETARY_SUPPLEMENT

acute intake of 2000 mg butyrate and hexanoate

butyrate and hexanoate amount 3

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (1)

• van Deuren T, Smolders L, Hartog A, Bouwman FG, Holst JJ, Venema K, Blaak EE, Canfora EE. Butyrate and hexanoate-enriched triglycerides increase postprandrial systemic butyrate and hexanoate in men with overweight/obesity: A double-blind placebo-controlled randomized crossover trial. Front Nutr. 2023 Jan 4;9:1066950. doi: 10.3389/fnut.2022.1066950. eCollection 2022.

  PMID: 36687671 DERIVED

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: January 13, 2021
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

NL (1)