Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | isocaloric placebo |
|
| whole fiber product | Experimental | 15 g for 2 weeks, followed by 30 g for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Supplementation period 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral insulin sensitivity | The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp | Before and 12 week after the start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| hepatic and adipose tissue insulin sensitivity | The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp | Before and 12 week after the start of the intervention |
| Energy expenditure (indirect calorimetry) |
Not provided
Inclusion criteria:
Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 kg/m2)
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Limburg | 5229ER | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40669445 | Derived | Omary L, Canfora EE, Puhlmann ML, Gavriilidou A, Rijnaarts I, Holst JJ, Op den Kamp-Bruls YMH, de Vos WM, Blaak EE. Intrinsic chicory root fibers modulate colonic microbial butyrate-producing pathways and improve insulin sensitivity in individuals with obesity. Cell Rep Med. 2025 Jul 15;6(7):102237. doi: 10.1016/j.xcrm.2025.102237. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Whole fiber product |
| Dietary Supplement |
Supplementation period 12 weeks |
|
The change in energy expenditure as measured via ventilated hood system |
| Before and 12 week after the start of the intervention |
| Substrate oxidation (indirect calorimetry) | The change in substrate oxidation as measured via ventilated hood system | Before and 12 week after the start of the intervention |
| Faecal and circulating SCFA | The change in faecal and circulating SCFA | Before and 12 week after the start of the intervention |
| Faecal microbiota composition and in vitro microbial activity testing | The change in faecal microbiota composition as assessed via 16s rRNA gene sequencing | Before and 12 week after the start of the intervention |
| In vitro microbial activity testing | The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon | Before and 12 week after the start of the intervention |
| Circulating hormones such as insulin | The change in circulating hormones in peripheral blood | Before and 12 week after the start of the intervention |
| Circulating metabolites such as glucose | The change in metabolites in peripheral blood | Before and 12 week after the start of the intervention |
| Circulating inflammatory markers such as TNF | The change in inflammatory markers in peripheral blood | Before and 12 week after the start of the intervention |
| body weight | The change in body weight in kg | Before and 12 week after the start of the intervention |
| body composition | The change in body compostion as assessed using DEXA scans | Before and 12 week after the start of the intervention |
| liver fat content | The change in liver fat content as assessed by proton magnetic resonance spectrometry | Before and 12 week after the start of the intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |