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Coffee Pilot1 2011-04
Coffee_pilot1
Parallel meal study with 21 volunteers randomized to drink 250mL coffee or water after 48 hours abstention from caffeinated foods or drinks. Three urine samples are collected, 1) a second morning void (fasting) before the drink 2) collection from 0-2 hours, 3) collection from 2-4 hours. Urine volume and density is recorded and urine samples are profiled by untargeted metabolomics on a C18 HSS T3 column eluted in reversed phase.
Start date
2022-08-28 00:00:00
Endpoint
Coffee intake biomarkers by metabolomics (explorative)
Objectives
Study designed for teaching metabolomics
Conclusion
Along with two additional studies, Coffee2 an -3 this work identified more than 20 putative biomarkers of coffee intake, see DOI: 10.1021/acs.jafc.1c01155
Exclusion
Pregnant or lactating women, unwilling to comply with study procedures
Inclusion
Providing informed consent
Inclusion
Providing informed consent
Country
Denmark
Consortium
FoodBAll
Published (PubMed)
34143629
Researchdesign
Research design
Blinding
No
Blinding method
Parallel
Research design description
Subjects arrived fasting and were randomized by drawing a number, pre-allocated by a blinded code table to receiving 250 mL coffee or water. The participants delivered a second morning urine void and then received their drink to be consumed within 15-20 minutes. Additional urine voids were collected at 2 and 4 hours. The samples were randomly placed on a 96-well plate, diluted 5x with aqueous internal standard, and profiled by LC-QTOF (see published paper), followed by data preprocessing without annotation. The raw data are available here: The processed dataset is shared in the current record.
Recruitment
Recruitment start year
Recruitment end year
Number of volunteers
Number of volunteers terminated
Factors
Number of treatments
One
Number of factors
1
Number of arms
2
Sea buckthorn decreases and delays insulin response and improves glycaemic profile following a sucrose-containing berry meal: a randomised, controlled, crossover study of Danish sea buckthorn and strawberries in overweight and obese male subjects
M208 - Berry study
The study was conducted as a randomised, controlled, single-blinded, three-way crossover study. Eighteen subjects were studied in three 2-h meal tests followed by a subsequent ad libitum meal. Test meals contained added sucrose and either sea buckthorn, strawberry or no berries with added fructose (control). Blood samples were collected at t = 0, 30, 45, 60, 90 and 120 min. Subjective appetite sensations were recorded at t = 0, 15, 30, 45, 60, 90, 120, and 140 min and subsequent ad libitum intake was recorded. Statistical differences in all continuous measures were evaluated based on the existence of a meal or a time–meal interaction by repeated measures linear model analyses or by differences in AUC by linear mixed models. Sequences of meals are as follows: Startgroup A (sea buckthorn, strawberry, control), Startgroup B (sea buckthorn, control, strawberry), Startgroup C (strawberry, control, sea buckthorn), Startgroup D (strawberry, sea buckthorn, control), and Startgroup E (control, sea buckthorn, strawberry).
Start date
2012-10-01 00:00:00
Endpoint
The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well as on metabolic profiles were examined in overweight or obese male subjects. The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at baseline and several times postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also collected at baseline and at several time intervals until 24 hours. Blood and urine were subjected to metabolic profiling to investigate potential biomarkers of berry intake.
Objectives
Berries and mixed berry products exert acute effects on postprandial glycaemia and insulinemia, but very few berries have been studied, and primarily in normal weight subjects. Sea buckthorn and strawberry are compositionally widely different berries and may likely produce different responses. The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia were examined in overweight or obese male subjects. Subjective appetite sensations and ad libitum intake were also examined. Berries may thus improve health in longer studies; however, accurate assessment of berry intake is still problematic. The discovery of objective biomarkers for intake of berries is therefore important in assessing both intake and compliance. The investigators aimed to identify urinary exposure markers of two very different berries, strawberry and sea buckthorn, in humans.
Conclusion
Exclusion
Any current or chronic clinical conditions Chronic/frequent use of medication Smoking Blood donation High level of strenuous physical activity (>10h/week) High habitual alcohol consumption (>14 drinks/week) Present or previous drug abuse Participation in other human intervention studies, and obesity surgery
Inclusion
Healthy, male, aged 20-50 years and body mass index (BMI) 25-35 kg/m2
Inclusion
Healthy, male, aged 20-50 years and body mass index (BMI) 25-35 kg/m2
Country
Denmark
Consortium
Published (PubMed)
Researchdesign
Research design
Blinding
Yes
Blinding method
Crossover
Research design description
The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at t = 0, 30, 45, 60, 90 and 120 min. Subjective appetite sensations were recorded at t = 0, 15, 30, 45, 60, 90, 120 and 140 min and subsequent ad libitum intake was recorded. Statistical differences in all continuous measures were evaluated based on the existence of a meal or a time-meal interaction by repeated measurements analyses or differences in the area under the curve (AUC) for that measure in a linear mixed model. Urine samples were collected on each test day at t=-15min, t=0-1h, t=1-2h, and t=2-24h and were analyzed by untargeted metabolomics. Multivariate analysis was applied to discover markers, followed by molecular fragmentation to ease their chemical identification.
Recruitment
Recruitment start year
2012
Recruitment end year
2012
Number of volunteers
18
Number of volunteers terminated
0
Factors
Number of treatments
3
Number of factors
3
Number of arms
5
Coffee pilot study 2
Coffee_pilot_2
Parallel meal pilot study from 2011 with 12 volunteers randomized to drink 250mL coffee or water after 12 h fasting. Three urine samples are collected, 1) a second morning void (fasting) before the drink 2) collection from 0-2 hours, 3) collection from 2-4 hours. Urine metabolic profiles in NEG and POS mode are recorded.
Start date
2023-02-09 00:00:00
Endpoint
Objectives
Conclusion
Exclusion
Inclusion
Inclusion
Country
Consortium
Published (PubMed)
Researchdesign
Research design
Blinding
No
Blinding method
Parallel
Research design description
Recruitment
Recruitment start year
2011
Recruitment end year
2011
Number of volunteers
12
Number of volunteers terminated
0
Factors
Number of treatments
2
Number of factors
2
Number of arms
2
Coffee_pilot_3
Coffee_pilot_3
Parallel meal pilot study from 2014 with 7 volunteers randomized to drink 250mL coffee or water after 12 h fasting. Three urine samples are collected, 1) a second morning void (fasting) before the drink 2) collection from 0-2 hours, 3) collection from 2-5 hours. Urine metabolic profiles in NEG and POS mode are recorded, and urine density and volume.
Start date
2023-02-10 00:00:00
Endpoint
Objectives
Conclusion
Exclusion
Inclusion
Inclusion
Country
Consortium
Published (PubMed)
Researchdesign
Research design
Blinding
No
Blinding method
Parallel
Research design description
Recruitment
Recruitment start year
2014
Recruitment end year
2014
Number of volunteers
7
Number of volunteers terminated
0
Factors
Number of treatments
2
Number of factors
2
Number of arms
2
A personal microbiome-dependent glucose response in healthy young volunteers: a meal test study
MIGLUCOSE
The gut microbiome has combined with other person-specific information, such as blood parameters, dietary habits, anthropometrics, and physical activity been found to predict personalized postprandial glucose responses (PPGRs) to various foods. Yet, the contributions of specific microbiome taxa, measures of fermentation, and abiotic factors in the colon to glycemic control remain elusive. We tested whether PPGRs 60 min after a standardized breakfast was associated with gut microbial α-diversity (primary outcome) and explored whether postprandial responses of glucose and insulin were associated with specific microbiome taxa, colonic fermentation as reflected by fecal short-chain fatty acids (SCFAs), and breath hydrogen and methane exhalation, as well as abiotic factors including fecal pH, fecal water content, fecal energy density, intestinal transit time (ITT), and stool consistency. A single-arm meal trial was conducted. A total of 31 healthy (24 female and seven male) subjects consumed a standardized evening meal and a subsequent standardized breakfast (1,499 kJ) where blood was collected for analysis of postprandial glucose and insulin responses. PPGRs to the same breakfast varied across the healthy subjects. The largest inter-individual variability in PPGRs was observed 60 min after the meal but was not associated with gut microbial α-diversity. In addition, no significant associations were observed between postprandial responses and specific taxa of the gut microbiome, measures of colonic fermentation, ITT, or other abiotic factors. However, fasting glucose concentrations were negatively associated with ITT, and fasting insulin was positively associated with fasting breath hydrogen. In conclusion, the gut microbiome, measures of colonic fermentation, and abiotic factors were not shown to be significantly associated with variability in postprandial responses, suggesting that contributions of the gut microbiome, colonic fermentation, and abiotic factors to PPGRs may be subtle in healthy adults.
Start date
2018-10-12 00:00:00
Endpoint
Postprandial plasma glucose at 60 min as a function of gut microbial richness
Objectives
Conclusion
Exclusion
Inclusion
Inclusion
Country
Denmark
Consortium
Published (PubMed)
Researchdesign
Research design
Blinding
No
Blinding method
Research design description
single-arm meal study
Recruitment
Recruitment start year
2018
Recruitment end year
2018
Number of volunteers
31
Number of volunteers terminated
31
Factors
Number of treatments
1
Number of factors
1
Number of arms
1
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