The objective of this project is to identify a well consumable butyrate/hexanoate-enriched oil that increase circulating SCFA levels and improves postprandial substrate metabolism. We will investigate the effects of acute intake of four different…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters:
The effects of acute supplementation of four different concentrations of
butyrate/hexanoate-enriched oil on plasma SCFA availability
Primary endpoint: Plasma SCFA concentrations.
Secondary outcome
- Circulating hormone concentrations (Insulin, GLP-1)
- Circulating metabolite concentrations (Glucose, Free Fatty Acids, Glycerol
and Triglycerides (TG));
- Circulating inflammatory markers (TNFα, IL1β, IL6 and IL8)
- Appetite (Visual Analog Scales (VAS)-scoring system for hunger and satiety).
- Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
- Three-day food record. A three-day food record will be completed three days
prior to each clinical investigation day.
- Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.
Background summary
The gut microbiota is being increasingly recognized as an important factor in
fat distribution, insulin sensitivity and glucose and lipid metabolism.
Accordingly, the intestinal microbiota could play an important role in the
development of obesity and type 2 diabetes. One of the important functions of
the human microbiota is the fermentation of indigestible carbohydrates, i.e.
dietary fiber or resistant starches. The major products of this saccharolytic
fermentation process are short-chain fatty acids (SCFA), such as butyrate. Of
note, several rodent in vivo studies showed that SCFA supplementation prevented
diet-induced obesity and insulin resistance.
Even if the knowledge improved, in the present time, our understanding of the
effects of SCFA on human metabolism is still limited. We previously performed
acute studies where we administered SCFA in the colon of healthy, overweight
men (METC 11-3-079, METC13-3-022). Our results demonstrated that an increase in
circulating levels of SCFA are necessary to elicit beneficial effects on human
substrate and energy metabolism. In another clinical trial, oral sodium
butyrate intake resulted in improved insulin sensitivity in healthy adults and
an improved anti-inflammatory response in adults with metabolic syndrome.
However, the long-term effect of elevated intestinal and systemic butyrate
concentrations on metabolic health has never been studied. Interestingly,
hexanoate (also known as capronic acid, C6), another SCFA, can also be produced
by the gut microbiota and is inversely associated with the inflammatory state.
Therefore, a mixture of butyrate and hexanoate may be an interesting approach
to combat obesity-associated chronic low-grade inflammation and tissue specific
metabolic dysfunctions.
In this public-private partnership project, 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.
Study objective
The objective of this project is to identify a well consumable
butyrate/hexanoate-enriched oil that increase circulating SCFA levels and
improves postprandial substrate metabolism.
We will investigate the effects of acute intake of four different
concentrations of a butyrate/hexanoate-enriched oil (Akovita Postbiotics range)
on plasma SCFA availability and markers of substrate and energy metabolism
during postprandial conditions in overweight/obese men.
Study design
Double blind, placebo-controlled, randomized, crossover design.
Intervention
During the clinical investigation day, participants will ingest a liquid
high-fat mixed meal enriched with four different concentrations of a
butyrate/hexanoate-enriched oil:
1. Placebo: 0 mg butyrate and hexanoate (10g high oleic sunflower oil (Fritex
HOSO, AAK, The Netherlands))
2. 650 mg of butyrate and hexanoate (~8.6 g Akovita SCT-FAT8.5% and 1.4 g high
oleic sunflower oil (AAK, The Netherlands))
3. 1325 mg of butyrate and hexanoate (~7.2 g Akovita SCT-FAT8.5%, 2.7 g Akovita
SCT-FAT30%, and 0.1 g high oleic sunflower oil, (AAK, The Netherlands))
4. 2000 mg of butyrate and hexanoate (8.6g Akovita SCT-FAT30% and 1.4 g high
oleic sunflower oil, (AAK, The Netherlands))
The type of intervention will be blinded for both the volunteers and the
researchers and provided in randomized order.
Study burden and risks
All participants will be screened before participation and thereby receive
information about their health status. In the future there can be general
health benefits for the public, but the volunteers will have no personal
benefits by participating in the study. The general interest of this study is
that there is a great lack in well consumable SCFA enriched foods, which can be
used for long term consumption to improve the control of body weight and
insulin sensitivity.
The products used in this study are evaluated as safe for human use. All
ingredients of the oil are regularly consumed in the form of i.e. food dairy
products such as butter, ghee, raw milk, animal fats, fermented foods and food
additives. In this study the volunteers may experience the following as a
burden. After initial screening, subjects will have to invest approximately 28
hours in the study and have to fill in food diaries at home. During the
clinical investigations days, blood will be collected via a venous catheter.
Venepunctures can occasionally cause a local hematoma or bruise to occur. Some
participants report pain during venepuncture.
*
Universiteitssingel 50
Maastricht 5229ER
NL
Universiteitssingel 50
Maastricht 5229ER
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75253.068.20 |