Effects of Functional Ingredients in an Acute Metabolic Challenge Context
NCT ID: NCT02623608
Last Updated: 2019-08-22
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
15 participants
INTERVENTIONAL
2015-08-31
2016-07-31
Brief Summary
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Detailed Description
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A randomized crossover design will be followed, in which the postprandial metabolic responses to a high fat breakfast (HF) will be compared with those registered after an identical breakfast containing a functional ("active") ingredient. Each meal will be tested in an independent experimental session. Experimental sessions will take place with1 week interval. The study will be carried out at the Food for Health Laboratory, Food for Health Science Centre - Lund University (Medicon Village, Lund).
The volunteers will consume the challenge HF alone and with 4 active ingredients, i.e. each volunteer will undergo five experimental sessions. Additionally, the plan contemplates an initial information visit that includes the screening of fasting blood glucose. In total, each volunteer completing the study will pay six visits to the Food for Health Laboratory.
Based on the results from the above-described phase, a second step of the study will focus on the impact of the order of consumption -i.e. "active ingredient" before HF and vice versa on cardiometabolic risk outcomes, as a way to optimize putative protective actions.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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High fat meal
Subjects eat a high fat breakfast (reference breakfast) at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
Reference breakfast
A high fat, high calorie breakfast
High fat meal + Active Ingredient 1
Subjects eat the same high fat breakfast with the "active ingredient 1" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
Active Ingredient 1
A high fat, high calorie breakfast including the Active Ingredient 1
High fat meal + Active Ingredient 2
Subjects eat the same high fat breakfast with the "active ingredient 2" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
Active Ingredient 2
A high fat, high calorie breakfast including the Active Ingredient 2
High fat meal + Active Ingredient 3
Subjects eat the same high fat breakfast with the "active ingredient 3" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
Active Ingredient 3
A high fat, high calorie breakfast including the Active Ingredient 3
High fat meal + Active Ingredient 4
Subjects eat the same high fat breakfast with the "active ingredient 4" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
Active Ingredient 4
A high fat, high calorie breakfast including the Active Ingredient 4
Interventions
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Reference breakfast
A high fat, high calorie breakfast
Active Ingredient 1
A high fat, high calorie breakfast including the Active Ingredient 1
Active Ingredient 2
A high fat, high calorie breakfast including the Active Ingredient 2
Active Ingredient 3
A high fat, high calorie breakfast including the Active Ingredient 3
Active Ingredient 4
A high fat, high calorie breakfast including the Active Ingredient 4
Eligibility Criteria
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Inclusion Criteria
* fasting blood glucose value ≤ 6.1 mmol/l.
Exclusion Criteria
* treatment for hypertension
50 Years
73 Years
ALL
Yes
Sponsors
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Vinnova
OTHER_GOV
Antidiabetic Food Centre AFC
UNKNOWN
Lund University
OTHER
Responsible Party
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Juscelino Tovar
Project Leader
Principal Investigators
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Juscelino Tovar, PhD
Role: STUDY_DIRECTOR
Lund University
Locations
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Food for Health Science Centre. Lund University Medicon Village
Lund, , Sweden
Countries
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References
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O'Keefe JH, Bell DS. Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol. 2007 Sep 1;100(5):899-904. doi: 10.1016/j.amjcard.2007.03.107. Epub 2007 Jun 26.
Johnston KL, Clifford MN, Morgan LM. Coffee acutely modifies gastrointestinal hormone secretion and glucose tolerance in humans: glycemic effects of chlorogenic acid and caffeine. Am J Clin Nutr. 2003 Oct;78(4):728-33. doi: 10.1093/ajcn/78.4.728.
Strassburg K, Esser D, Vreeken RJ, Hankemeier T, Muller M, van Duynhoven J, van Golde J, van Dijk SJ, Afman LA, Jacobs DM. Postprandial fatty acid specific changes in circulating oxylipins in lean and obese men after high-fat challenge tests. Mol Nutr Food Res. 2014 Mar;58(3):591-600. doi: 10.1002/mnfr.201300321. Epub 2013 Oct 14.
Herieka M, Erridge C. High-fat meal induced postprandial inflammation. Mol Nutr Food Res. 2014 Jan;58(1):136-46. doi: 10.1002/mnfr.201300104. Epub 2013 Jul 12.
Related Links
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Food for Health Science Centre/Antidiabetic Food Centre, hosts of the study
Published results
Published results
Other Identifiers
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AFC-JT-Ac.Ch
Identifier Type: -
Identifier Source: org_study_id
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