Butyrate/Hexanoate in Metabolic Health

Study Overview
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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.

Official Title
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Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health

Conditions
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Metabolic Disease

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: butyrate and hexanoate amount 1
* Dietary Supplement: butyrate and hexanoate amount 2
* Dietary Supplement: butyrate and hexanoate amount 3


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* acute intake of 0 mg butyrate and hexanoate<br>|
| Experimental: butyrate and hexanoate amount 1<br>1325 mg of butyrate and hexanoate | Dietary Supplement: butyrate and hexanoate amount 1<br>* acute intake of 650 mg butyrate and hexanoate<br>|
| Experimental: butyrate and hexanoate amount 2<br> | Dietary Supplement: butyrate and hexanoate amount 2<br>* acute intake of 1325 mg butyrate and hexanoate<br>|
| Experimental: butyrate and hexanoate amount 3<br> | Dietary Supplement: butyrate and hexanoate amount 3<br>* acute intake of 2000 mg butyrate and hexanoate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |