search
Back to results

Butyrate/Hexanoate in Metabolic Health

Primary Purpose

Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Placebo
butyrate and hexanoate amount 1
butyrate and hexanoate amount 2
butyrate and hexanoate amount 3
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

butyrate and hexanoate amount 1

butyrate and hexanoate amount 2

butyrate and hexanoate amount 3

Arm Description

1325 mg of butyrate and hexanoate

Outcomes

Primary Outcome Measures

Plasma butyrate concentrations
Plasma butyrate concentrations

Secondary Outcome Measures

Circulating Glucose
Circulating Glucose assessed in plasma
Circulating Free Fatty Acids
Circulating Free Fatty Acids assessed in plasma
Circulating Glycerol
Circulating Glycerol assessed in plasma
Circulating Triglycerides (TG)
Circulating Triglycerides assessed in plasma
Circulating insulin
Circulating . insulin will be assessed in plasma
Breath H2
Breath H2 using Gastrolyzer

Full Information

First Posted
December 4, 2020
Last Updated
November 26, 2021
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04662411
Brief Title
Butyrate/Hexanoate in Metabolic Health
Official Title
Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
butyrate and hexanoate amount 1
Arm Type
Experimental
Arm Description
1325 mg of butyrate and hexanoate
Arm Title
butyrate and hexanoate amount 2
Arm Type
Experimental
Arm Title
butyrate and hexanoate amount 3
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
acute intake of 0 mg butyrate and hexanoate
Intervention Type
Dietary Supplement
Intervention Name(s)
butyrate and hexanoate amount 1
Intervention Description
acute intake of 650 mg butyrate and hexanoate
Intervention Type
Dietary Supplement
Intervention Name(s)
butyrate and hexanoate amount 2
Intervention Description
acute intake of 1325 mg butyrate and hexanoate
Intervention Type
Dietary Supplement
Intervention Name(s)
butyrate and hexanoate amount 3
Intervention Description
acute intake of 2000 mg butyrate and hexanoate
Primary Outcome Measure Information:
Title
Plasma butyrate concentrations
Description
Plasma butyrate concentrations
Time Frame
Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement
Secondary Outcome Measure Information:
Title
Circulating Glucose
Description
Circulating Glucose assessed in plasma
Time Frame
Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement
Title
Circulating Free Fatty Acids
Description
Circulating Free Fatty Acids assessed in plasma
Time Frame
Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement
Title
Circulating Glycerol
Description
Circulating Glycerol assessed in plasma
Time Frame
Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement
Title
Circulating Triglycerides (TG)
Description
Circulating Triglycerides assessed in plasma
Time Frame
Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement
Title
Circulating insulin
Description
Circulating . insulin will be assessed in plasma
Time Frame
Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement
Title
Breath H2
Description
Breath H2 using Gastrolyzer
Time Frame
Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Butyrate/Hexanoate in Metabolic Health

We'll reach out to this number within 24 hrs