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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05354245
Other study ID # NL80459.068.22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2022
Est. completion date December 2024

Study information

Verified date April 2024
Source Maastricht University Medical Center
Contact Colin AJ van Kalkeren, M.D.
Phone +31 (0)43 3881638
Email c.vankalkeren@maastrichtuniversity.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria: - Age 30-75 years - Male/female - BMI 28-40 kg/m2 - Impaired fasting glucose or glucose tolerance, determined using the following criteria (participant should meet at least one criteria): - HbA1c 42-47 mmol/mol OR fasting glucose (>10h fasted) 5.6-6.9 mmol/l OR Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) >1.85 Exclusion Criteria: - Diabetes mellitus (type 1 or 2) - Cardiovascular disease (except hypertension (<160/100mmHg is allowed), pulmonary disease, kidney disease/failure, liver disease/failure - Gastrointestinal disease or a history of abdominal surgery (except appendectomy and cholecystectomy) - Diseases affecting glucose and/or lipid metabolism - Malignancy (except non-invasive skin cancer) - Auto-immune disease - Major mental disorders - Ongoing (infectious) disease or any disease with a life expectancy =5 years - Substance abuse (nicotine abuse (including e-cigarettes) defined as >20 cigarettes per day; alcohol abuse defined as =8 drinks/week for females and =15 drinks/week for males(38); any drugs) - A change in weight =3kg over the last 3 months or plans to lose weight or follow a hypocaloric diet during the study period - Pre/pro/antibiotic use in the last 3 months or during the study - Use of medication that influences glucose or fat metabolism and inflammation, such as: - Use of statins (stable use =3 months prior to and during study is allowed) - Use of antidepressants (stable use =3 months prior to and during study is allowed) - Use of specific anticoagulants - Use of medication known to interfere with study outcomes - Use of ß-blockers - Chronic corticosteroid treatment (>7 consecutive days) - Regular use of laxatives 3 months prior to the study or during study period - Change in physical activity or diet during study period - Intensive physical activity (>3h per week) - Pregnancy - Following a vegan or vegetarian diet; presence of food allergies, intolerances or diet restrictions interfering with the study.

Study Design


Intervention

Dietary Supplement:
Fibre supplement (potato-pectin)
Fibre supplement
Placebo
Maltodextrin
High-protein diet
High-protein diet

Locations

Country Name City State
Netherlands Maastricht University Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Carbohydrate Competence Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Blaak EE, Canfora EE, Theis S, Frost G, Groen AK, Mithieux G, Nauta A, Scott K, Stahl B, van Harsselaar J, van Tol R, Vaughan EE, Verbeke K. Short chain fatty acids in human gut and metabolic health. Benef Microbes. 2020 Sep 1;11(5):411-455. doi: 10.3920/BM2020.0057. Epub 2020 Aug 31. — View Citation

Blaak EE. Current metabolic perspective on malnutrition in obesity: towards more subgroup-based nutritional approaches? Proc Nutr Soc. 2020 Aug;79(3):331-337. doi: 10.1017/S0029665120000117. Epub 2020 Mar 3. — View Citation

Canfora EE, Jocken JW, Blaak EE. Short-chain fatty acids in control of body weight and insulin sensitivity. Nat Rev Endocrinol. 2015 Oct;11(10):577-91. doi: 10.1038/nrendo.2015.128. Epub 2015 Aug 11. — View Citation

Canfora EE, Meex RCR, Venema K, Blaak EE. Gut microbial metabolites in obesity, NAFLD and T2DM. Nat Rev Endocrinol. 2019 May;15(5):261-273. doi: 10.1038/s41574-019-0156-z. — View Citation

Canfora EE, van der Beek CM, Jocken JWE, Goossens GH, Holst JJ, Olde Damink SWM, Lenaerts K, Dejong CHC, Blaak EE. Colonic infusions of short-chain fatty acid mixtures promote energy metabolism in overweight/obese men: a randomized crossover trial. Sci Rep. 2017 May 24;7(1):2360. doi: 10.1038/s41598-017-02546-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Peripheral insulin sensitivity Change in peripheral insulin sensitivity between the two groups. Measured using a two-step hyperinsulinemic-euglycemic clamp 12 weeks
Secondary Insulin sensitivity (hepatic and adipose tissue) Change in insulin sensitivity between the two groups. Measured using a two-step hyperinsulinemic-euglycemic clamp 12 weeks
Secondary Gut permeability Difference in change between the groups. Measured using multisugar test 12 weeks
Secondary Inflammation Difference in change between the groups. Measured using serum values. 12 weeks
Secondary Energy and substrate metabolism Difference in change between the groups. Measured using serum values (circulating metabolites) and indirect calorimetry (energy harvest and expenditure) 12 weeks
Secondary 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.
12 weeks
Secondary 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
12 weeks
Secondary 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) 12 weeks
Secondary 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. 12 weeks
Secondary 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)
12 weeks
Secondary Stool consistency Difference in change between the groups. Measured by bristol stool scale (7-point scale (1 = solid feces, 7 = severe diarrhoea) 12 weeks
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