Butyrate/Hexanoate in Metabolic Health

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04662411
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 4
• Actual Duration (Months): 6.4
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disease	Dietary Supplement: Placebo; Dietary Supplement: butyrate and hexanoate amount 1; Dietary Supplement: butyrate and hexanoate amount 2; Dietary Supplement: butyrate and hexanoate amount 3	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health
• Actual Study Start Date: Jan 13, 2021
• Actual Primary Completion Date: Jul 26, 2021
• Actual Study Completion Date: Jul 26, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Plasma butyrate concentrations [Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement]

   Plasma butyrate concentrations

Secondary Outcome Measures

1. Circulating Glucose [Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement]

   Circulating Glucose assessed in plasma

2. 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 Free Fatty Acids assessed in plasma

3. Circulating Glycerol [Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement]

   Circulating Glycerol assessed in plasma

4. Circulating Triglycerides (TG) [Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement]

   Circulating Triglycerides assessed in plasma

5. Circulating insulin [Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement]

   Circulating . insulin will be assessed in plasma

6. Breath H2 [Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement]

   Breath H2 using Gastrolyzer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Centre	Maastricht		Netherlands

Sponsors and Collaborators

• Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT04662411
• Other Study ID Numbers: NL75253.068.20
• First Posted: Dec 10, 2020
• Last Update Posted: Nov 29, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases

Study Results

No Results Posted as of Nov 29, 2021