Timmers 2016.
Methods | Study design: cross‐over randomised controlled clinical trial; randomisation ratio not reported | |
Participants |
Inclusion criteria
Exclusion criteria
Diagnostic criteria: not reported Setting: outpatients Age group: adults Gender distribution: males Country where study was performed: Netherlands |
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Interventions |
Intervention(s): trans‐resveratrol Softgel Comparator(s): placebo Duration of intervention: 2 × 30 days intervention period with 30 days washout period (cross‐over study) Duration of follow‐up: 30 days Run‐in period: not reported Number of study centres: 1 Extension period: none |
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Outcomes | Reported outcome(s) in full text of publication: insulin sensitivity, intrahepatic lipid content, intramyocellular lipids, mitochondrial function (in vivo and ex vivo), blood pressure, and cardiac function | |
Study details |
Trial identifier:NCT01638780 Study terminated early: no |
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Publication details |
Language of publication: English Funding: non‐commercial funding (European Foundation for the Study of Diabetes Clinical Research Grant) Publication status: peer‐reviewed journal |
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Stated aim for study | Quote: "to examine if 30 days of resveratrol (resVida) supplementation leads to an improvement in peripheral and hepatic insulin sensitivity in subjects with well‐controlled T2D" | |
Notes | "In randomized order, participants underwent two experimental trials: a placebo and a resVida (150 mg/day trans‐resveratrol [99.9%]; provided by DSM Nutritional Products Ltd.) condition, with a washout period of at least 30 days" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote from publication: "Randomization was performed according to standard procedures as described in Statistical Methods by Snedecor and Cochran" Comment: probably performed correctly |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not reported |
Blinding of participants and personnel (performance bias) adverse events | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of participants and personnel (performance bias) all‐cause mortality | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of participants and personnel (performance bias) fasting blood glucose | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of participants and personnel (performance bias) HbA1c | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of participants and personnel (performance bias) insulin sensitivity | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of outcome assessment (detection bias) adverse events | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of outcome assessment (detection bias) all‐cause mortality | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of outcome assessment (detection bias) fasting blood glucose | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of outcome assessment (detection bias) HbA1c | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Blinding of outcome assessment (detection bias) insulin sensitivity | Low risk |
Quote from publication: "Subjects with well‐controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day resveratrol (resVida) in a randomized double‐blind crossover study for 30 days" Quote from trials register: "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
Incomplete outcome data (attrition bias) adverse events | Low risk | Comment: no missing data |
Incomplete outcome data (attrition bias) all‐cause mortality | Low risk | Comment: no missing data |
Incomplete outcome data (attrition bias) fasting blood glucose | Low risk | Comment: no missing data |
Incomplete outcome data (attrition bias) HbA1c | Low risk | Comment: no missing data |
Incomplete outcome data (attrition bias) insulin sensitivity | Low risk | Comment: no missing data |
Selective reporting (reporting bias) | Low risk | Comment: protocol available; outcomes reported in the protocol match the outcomes reported in the results section |
Other bias | Low risk | Quote: "potential carryover effect between treatment and period was examined by unpaired t test analyses according to Pocock (29)" |
Note: Where the judgement is 'Unclear' and the description is blank, the study did not report that particular outcome.
BMI: body mass index, eGFR: estimated glomerular filtration rate, GLP‐1: glucagon‐peptide 1, HbA1c: glycosylated haemoglobin A1c, IFCC: International Federation of Clinical Chemistry, WHO: World Health Organization.