Human Milk Oligossaccharide and Acetate Production in Vivo
NCT ID: NCT04795804
Last Updated: 2021-11-03
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
19 participants
INTERVENTIONAL
2020-02-04
2021-10-15
Brief Summary
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To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo
11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day
Maltodextrin
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Human milk-like oligosaccharide alone
12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day
Human Milk Oligossaccharide
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Human milk-like oligosaccharide and resistant starch
12 g (3 x 4 g) of the human milk-like oligosaccharide and 7.5g resistant starch (3 x 2.5 g) the day before the clinical investigation day
Human Milk Oligossaccharide and resistant starch
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Interventions
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Human Milk Oligossaccharide
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Maltodextrin
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Human Milk Oligossaccharide and resistant starch
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Eligibility Criteria
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Inclusion Criteria
as well as
overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years
Exclusion Criteria
* Gastroenterological diseases or abdominal surgery;
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day;
* Plans to lose weight or following of a hypocaloric diet;
* Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
* Intensive exercise training more than three hours a week;
* Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
* Regular use of laxation products;
* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
* Follow a vegan diet.
30 Years
65 Years
MALE
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Maastricht University
Maastricht, Limburg, Netherlands
Countries
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References
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Canfora EE, Vliex LMM, Wang T, Nauta A, Bouwman FG, Holst JJ, Venema K, Zoetendal EG, Blaak EE. 2'-fucosyllactose alone or combined with resistant starch increases circulating short-chain fatty acids in lean men and men with prediabetes and obesity. Front Nutr. 2023 Jul 17;10:1200645. doi: 10.3389/fnut.2023.1200645. eCollection 2023.
Other Identifiers
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NL71611.068.19
Identifier Type: -
Identifier Source: org_study_id