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Trial record 8 of 134 for:    SRT501 AND Platelet Aggregation

Long-term Resveratrol and Metabolism

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ClinicalTrials.gov Identifier: NCT02565979
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : October 18, 2017
Sponsor:
Collaborators:
Diabetes Fonds
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
The main objective of the study is to investigate if 6 months resveratrol supplementation can improve glucose tolerance in overweight/obese individuals. As secondary objectives we want to investigate whether resting energy metabolism, intra-hepatic lipid content, physical performance, body composition and quality of life change by 6 months resveratrol supplementation in these individuals.

Condition or disease Intervention/treatment Phase
Pre-diabetes Dietary Supplement: resveratrol Dietary Supplement: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Long-term Resveratrol Supplementation on Metabolic Health
Study Start Date : April 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Active Comparator: Resveratrol
resveratrol will be given for 6 months, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.
Dietary Supplement: resveratrol
Resveratrol will be given for 6 months, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
Other Name: resVida (99% trans-resveratrol)

Placebo Comparator: Placebo
placebo will be given for 6 months, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.
Dietary Supplement: placebo
A placebo will given for 6 months, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.




Primary Outcome Measures :
  1. Change in Glucose Tolerance [ Time Frame: 2x baseline and 2x after 6 months of supplemenation ]
    Matsuda Index calculated from double 2-hour Oral Glucose Tolerance Test (OGTT)


Secondary Outcome Measures :
  1. Change in Intra-hepatic lipid content [ Time Frame: baseline and after 6 months of supplemenation ]
    Intra-hepatic lipid content measured with 1H-MRS

  2. Change in Resting energy expenditure [ Time Frame: baseline and after 6 months of supplemenation ]
    energy expenditure and substrate oxidation will be measured by an automated ventilated hood system (45 minutes) to determine whole body energy metabolism

  3. Change in Body composition [ Time Frame: baseline and after 6 months of supplemenation ]
    Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan

  4. Change in Blood plasma markers [ Time Frame: Once a month for a period of 6 months ]
    Markers related to energy metabolism (for instance glucose, insulin, free fatty acids, cholesterol, glycerol and triglycerides) will be measured regularly

  5. Change in Blood pressure [ Time Frame: Once a month for a period of 6 months ]
    blood pressure (diastolic and systolic blood pressure and heart rate) will be measured once a month

  6. Change in Physical performance [ Time Frame: baseline and after 6 months of supplemenation ]
    Physical performance will be assessed by the following tests: the Timed Chair Stand Test; the 6-minute walk test while they wear a MOX Activity Monitor; and a dynamometer (Biodex) will be used to determine isometric and isokinetic muscle strength of the extensor and flexor muscles of the knee joint

  7. Change in Quality of life [ Time Frame: baseline and after 6 months of supplemenation ]
    Quality of life (QoL) will be tested using a 32-item questionnaire. This measure quantifies QoL on the dimensions Social, Spiritual, Emotional, Cognitive, Physical, Activities of Daily Living, and Integrated QoL

  8. Change in Quality of sleep [ Time Frame: baseline and after 6 months of supplemenation ]
    Sleep quality will be measured by the 10-item Pittsburg Sleep Quality Index



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men aged 40-70 years and postmenopausal women aged 50-70 years
  • BMI: 27-35 kg/m2
  • Stable dietary habits: no weight gain or loss > 5kg in the last three months
  • Willingness to limit consumption of resveratrol-containing food products and willingness to refrain from using resveratrol containing supplements
  • Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening

Exclusion Criteria:

  • Uncontrolled hypertension
  • HbA1c > 6.5%
  • Previously diagnosed with type 2 diabetes
  • Medication use known to interfere with glucose homeostasis/metabolism
  • Current alcohol consumption > 20 grams alcohol/day
  • Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
  • Participation in another biomedical study within 1 month before the start of the intervention
  • Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565979


Contacts
Contact: Marlies de Ligt, MSc 0031 43 3881587 marlies.deligt@maastrichtuniversity.nl
Contact: Patrick Schrauwen, Prof. Dr. 0031 43 3881502 p.schrauwen@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University and Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Marlies de Ligt, MSc    +31 433 881587    marlies.deligt@maastrcihtuniversity.nl   
Contact: Patrick Schrauwen, Prof., Dr.    +31 433 881502    p.schrauwen@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Diabetes Fonds
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Patrick Schrauwen, Prof. Dr. Maastricht University Medical Centre

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02565979     History of Changes
Other Study ID Numbers: 15-3-037
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Maastricht University Medical Center:
Resveratrol
Diabetes Mellitus, Type 2
Insulin Resistance
Metabolic Diseases
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Resveratrol
Platelet Aggregation Inhibitors
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents