Maastricht University
Maastricht, Limburg, 5229ER, Netherlands
NCT Number: NCT05378295
In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives:
1. To investigate whether a mixture of fermentable fibres, which differ in DP and side chains, will stimulate a broad range of SCFA-producing bacterial genera, resulting in enhanced chronic SCFA production throughout the whole colon with a large variation between individuals; 2. To unravel whether providing personalized fibre mixtures, selected based on the individuals' initial microbiota and capacity for SCFA production is crucial to successfully improve host insulin sensitivity and metabolic health
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Notify Me30 year–70 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 5229ER, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 < 40 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 (m-value) 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 concentrations of circulating SCFA
Time frame: Before and 12 week after the start of the intervention
The change in concentrations of faecal SCFA
Time frame: Before and 12 week after the start of the intervention
The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene
Time frame: Before and 12 week after the start of the intervention
The change in concentrations of circulating hormones in peripheral blood
Time frame: Before and 12 week after the start of the intervention
The change in concentrations of metabolites in peripheral blood
Time frame: Before and 12 week after the start of the intervention
The change in body fat percentage as assessed using DEXA scans
Time frame: Before and 12 week after the start of the intervention
The change in fat mass in kg as assessed using DEXA scans
Time frame: Before and 12 week after the start of the intervention
The change in lean mass in kg as assessed using DEXA scans
Time frame: Before and 12 week after the start of the intervention
The change in visceral fat in gram as assessed using DEXA scans
Time frame: Before and 12 week after the start of the intervention
The change in body weight in kg using a weight scale
Maastricht University Medical Center
Other
Personalized Microbial Substrates to Prevent Type 2 Diabetes
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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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