Clinical trial NCT04714944: Fiber and Insulin Sensitivity
Official title: Gut Microbial Substrate Switch to Improve Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.

The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.


Eligibility criteria: Inclusion criteria:

Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 \< 35 kg/m2)

Exclusion criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
* Gastroenterological diseases or abdominal surgery;
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day;
* Plans to lose weight or following of a hypocaloric diet;
* Regular supplementation of pre- or probiotic products, 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. NSAIDs);
* Regular use of laxation products;
* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
* Follow a vegetarian diet.
* Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)
* The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck
* Claustrophobia

Primary outcomes:
measure: Peripheral insulin sensitivity
timeFrame: Before and 12 week after the start of the intervention
Secondary outcomes:
measure: hepatic and adipose tissue insulin sensitivity
timeFrame: Before and 12 week after the start of the intervention
measure: Energy expenditure (indirect calorimetry)
timeFrame: Before and 12 week after the start of the intervention
measure: Substrate oxidation (indirect calorimetry)
timeFrame: Before and 12 week after the start of the intervention
measure: Faecal and circulating SCFA
timeFrame: Before and 12 week after the start of the intervention
measure: Faecal microbiota composition and in vitro microbial activity testing
timeFrame: Before and 12 week after the start of the intervention
measure: In vitro microbial activity testing
timeFrame: Before and 12 week after the start of the intervention
measure: Circulating hormones such as insulin
timeFrame: Before and 12 week after the start of the intervention
measure: Circulating metabolites such as glucose
timeFrame: Before and 12 week after the start of the intervention
measure: Circulating inflammatory markers such as TNF
timeFrame: Before and 12 week after the start of the intervention
measure: body weight
timeFrame: Before and 12 week after the start of the intervention
measure: body composition
timeFrame: Before and 12 week after the start of the intervention
measure: liver fat content
timeFrame: Before and 12 week after the start of the intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: