Maastricht University
Maastricht, Limburg, 5229ER, Netherlands
NCT Number: NCT04714944
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.
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Notify Me45 year–70 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 5229ER, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 kg/m2)
Exclusion criteria
Supplementation period 12 weeks
Supplementation period 12 weeks
Time frame: Before and 12 week after the start of the intervention
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Time frame: Before and 12 week after the start of the intervention
The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Time frame: Before and 12 week after the start of the intervention
The change in energy expenditure as measured via ventilated hood system
Time frame: Before and 12 week after the start of the intervention
The change in substrate oxidation as measured via ventilated hood system
Time frame: Before and 12 week after the start of the intervention
The change in faecal and circulating SCFA
Time frame: Before and 12 week after the start of the intervention
The change in faecal microbiota composition as assessed via 16s rRNA gene sequencing
Time frame: Before and 12 week after the start of the intervention
The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon
Time frame: Before and 12 week after the start of the intervention
The change in circulating hormones in peripheral blood
Time frame: Before and 12 week after the start of the intervention
The change in metabolites in peripheral blood
Time frame: Before and 12 week after the start of the intervention
The change in inflammatory markers in peripheral blood
Time frame: Before and 12 week after the start of the intervention
The change in body weight in kg
Time frame: Before and 12 week after the start of the intervention
The change in body compostion as assessed using DEXA scans
Time frame: Before and 12 week after the start of the intervention
The change in liver fat content as assessed by proton magnetic resonance spectrometry
Maastricht University Medical Center
Other
Gut Microbial Substrate Switch to Improve Metabolic Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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