Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
NCT ID: NCT05354245
Last Updated: 2024-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2022-09-08
2024-06-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fibre mixture group
Use of a fibre mixture (3 times daily, 5 grams per gift, total of 15 grams per day) during 12 weeks
Fibre supplement (potato-pectin)
Fibre supplement
High-protein diet
High-protein diet
Placebo group
Use of a placebo (maltodextrin, isocaloric manner, 3 times daily) during 12 weeks.
Placebo
Maltodextrin
High-protein diet
High-protein diet
Interventions
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Fibre supplement (potato-pectin)
Fibre supplement
Placebo
Maltodextrin
High-protein diet
High-protein diet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 β-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.
30 Years
75 Years
ALL
Yes
Sponsors
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Carbohydrate Competence Center
UNKNOWN
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ellen E Blaak, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Maastricht University
Maastricht, , Netherlands
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NL80459.068.22
Identifier Type: -
Identifier Source: org_study_id
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