The purpose of this study is to investigate the effects of a fibre mixture added to a high-protein diet on metabolic, gut and brain health.
The fibre mixture that will be investigated is hypothesized to improved metabolic, gut and brain health. It potentially increases insulin sensitivity, satiety, gut barrier function, improves food-reward related brain activity and decreases inflammation, gut permeability, and ectopic lipid accumulation, among other potential health effects. The fibre mixture will be administrated during 12 weeks combined a high-protein diet. The placebo-controlled parallel design of the study allows for a placebo group to use maltodextrin combined with a high-protein diet for 12 weeks. The high-protein diet is known to increase satiety and might enhance the difference between the intervention and placebo groups in terms of outcome measurements. The potential health effects as described earlier will be investigated using different techniques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Fibre supplement
Maltodextrin
High-protein diet
Maastricht University
Maastricht, Netherlands
Peripheral insulin sensitivity
Change in peripheral insulin sensitivity between the two groups. Measured using a two-step hyperinsulinemic-euglycemic clamp
Time frame: 12 weeks
Insulin sensitivity (hepatic and adipose tissue)
Change in insulin sensitivity between the two groups. Measured using a two-step hyperinsulinemic-euglycemic clamp
Time frame: 12 weeks
Gut permeability
Difference in change between the groups. Measured using multisugar test
Time frame: 12 weeks
Inflammation
Difference in change between the groups. Measured using serum values.
Time frame: 12 weeks
Energy and substrate metabolism
Difference in change between the groups. Measured using serum values (circulating metabolites) and indirect calorimetry (energy harvest and expenditure)
Time frame: 12 weeks
Neurocognitive functioning
Difference in change between the groups. Measured using neurocognitive tests and functional Magnetic Resonance Imaging (fMRI). Neurocognitive functioning will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) (a combination of different digital tests) to assess response time in seconds and quality of delivered results. fMRI assesses food-reward related brain activity.
Time frame: 12 weeks
Food reward related brain activity
Difference in change between the groups. Measured using neurocognitive tests and fMRI. Neurocognitive functioning will be measured using CANTAB (a combination of different digital tests) to assess response time in seconds and quality of delivered results. fMRI assesses food-reward related brain activity
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Time frame: 12 weeks
Tissue metabolism (subcutaneous visceral adipose tissue, skeletal muscle tissue)
Difference in change between the groups regarding receptor expression and metabolic changes in different pathways (lipolysis, insulin signalling etc)
Time frame: 12 weeks
Microbiome composition and functionality
Difference in change between the groups. Measured using 16S-RNA sequencing and faecal analysis of substrates of saccharolytic and proteolytic fermentation.
Time frame: 12 weeks
Gastrointestinal side-effects of dietary supplement
Difference in change between the groups. Measured by gastrointestinal symptom rating scale and questionnaires on general wellbeing. Gastro-intestinal symptom rating scale: 15 questions on 7-point Likert scale (1 = strongly disagree; 7 = strongly agree)
Time frame: 12 weeks
Stool consistency
Difference in change between the groups. Measured by bristol stool scale (7-point scale (1 = solid feces, 7 = severe diarrhoea)
Time frame: 12 weeks