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Butyrate/Hexanoate in Metabolic Health

NCT ID: NCT04662411

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2021-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

acute intake of 0 mg butyrate and hexanoate

butyrate and hexanoate amount 1

1325 mg of butyrate and hexanoate

Group Type EXPERIMENTAL

butyrate and hexanoate amount 1

Intervention Type DIETARY_SUPPLEMENT

acute intake of 650 mg butyrate and hexanoate

butyrate and hexanoate amount 2

Group Type EXPERIMENTAL

butyrate and hexanoate amount 2

Intervention Type DIETARY_SUPPLEMENT

acute intake of 1325 mg butyrate and hexanoate

butyrate and hexanoate amount 3

Group Type EXPERIMENTAL

butyrate and hexanoate amount 3

Intervention Type DIETARY_SUPPLEMENT

acute intake of 2000 mg butyrate and hexanoate

Interventions

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Placebo

acute intake of 0 mg butyrate and hexanoate

Intervention Type DIETARY_SUPPLEMENT

butyrate and hexanoate amount 1

acute intake of 650 mg butyrate and hexanoate

Intervention Type DIETARY_SUPPLEMENT

butyrate and hexanoate amount 2

acute intake of 1325 mg butyrate and hexanoate

Intervention Type DIETARY_SUPPLEMENT

butyrate and hexanoate amount 3

acute intake of 2000 mg butyrate and hexanoate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Centre

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 36687671 (View on PubMed)

Other Identifiers

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NL75253.068.20

Identifier Type: -

Identifier Source: org_study_id