Phase IIa Study of Resveratrol to Enhance Mitochondrial and Physical Function in Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mitochondrial Respiration in Muscle
研究概览
简要总结
Resveratrol, a compound found in red wine and dark-skinned grapes, will improve the function of mitochondria (energy producing components) within the leg muscles of moderate functioning older adults.
The investigators will look at the role Resveratrol plays in improving physical function by studying the connection of changes in mitochondrial function and changes in physical function.
详细描述
An initial telephone screening indicated that the subject may be eligible to participate in the study. The first study visit ("Screening visit") will further determine if the subject is eligible to participate. Should the subject be eligible to participate in the study, the subject will be asked to participate in a daily resveratrol or placebo supplementation program for approximately 90 days. The subject will also be asked to return to the clinic for two additional assessment visits to monitor his/her safety and measure study results.
Details regarding the tests to be conducted during this screening visit and other study visits are described below. Visits will take place at the University of Florida Institute on Aging (IOA).
The Screening Visit is approximately 1.5 to 2 hours and will include:
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Blood Draw: The subject is asked to fast before the appointment because blood will be collected during this visit. The investigator will collect approximately 2 tablespoons of blood. The purpose of this blood draw is to determine levels of certain compounds in the subject's blood that will help determine eligibility.
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Questionnaires: The subject will be asked questions about medical history and medications as well as mood and will also be asked to complete a short test of memory and reasoning.
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Physical Measurements: measurements of the subject's height, body weight, waist circumference, pulse, and blood pressure.
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Physical Exam: A licensed health care provider will perform a brief physical exam to determine if it is safe to continue with the study. This exam will include a review of medical history, medications, and measurement of height, blood pressure, radial pulse, weight, and waist circumference.
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Tests of physical performance: The subject will be asked to complete tests of physical ability that include:
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Walking at the usual pace for a distance of 13 feet (4 meters) two (2) separate times
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The subject will be asked to go from a standing to a sitting position, without using their arms. If the subject is able to perform this task, then they will be asked to stand up from and sit down on chair five (5) times as fast as possible.
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Maintaining balance while standing in three (3) different positions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand study procedures and to comply with them for the entire length of the study;
- •Age 65 years and older;
- •Moderate to high functioning (i.e. a summary score of 4 - 10 on the Short Physical Performance Battery [SPPB]);
- •Body Mass Index (BMI) range: 20-39.9 kg/m2;
- •Willingness to undergo all testing procedures.
排除标准
- •Failure to provide informed consent;
- •Allergy/sensitivity to grapes or Japanese knotweed;
- •Current dietary supplementation of grape seed extract or ginko biloba;
- •Consumption of ≥ 8 oz. of red wine/dealcoholized red wine/red or purple grape juice more than once weekly;
- •Consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum in the previous 90 days;
- •Active treatment for cancer, stroke (< 6 months), peripheral vascular disease, coronary artery disease, myocardial infarction (< 6 months), congestive heart failure (stage III or IV), valvular heart disease, major psychiatric disease, severe anemia (blood levels of Hemoglobin < 8 g/dl), liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity ( < 6 months), upper or lower extremity amputation, or Parkinson's disease;
- •Cognitive impairment (i.e. Mini Mental Status Exam ≤ 23);
- •History of significant head injury;
- •Physical activity (i.e. running, bicycling, etc.) ≥ 120 min/week;
- •Excessive alcohol use (> 2 drinks/day) or alcohol abuse (> 5 drinks/day for males, or > 4 drinks/day for females);
- •History of substance abuse within the past six months;
- •Mood disorder (i.e. Center for Epidemiological Studies - Depression (CES-D) ≥ 16);
- •History of tobacco use within the past three years;
- •Resting heart rate > 120 bpm at screening visit;
- •Systolic blood pressure > 160 mm Hg at screening visit;
- •Diastolic blood pressure > 90 mm Hg at screening visit;
- •Fasting glucose ≥ 126 mg/dL at screening visit;
- •Abnormalities in blood chemistry parameters, defined by blood chemistry marker outside of healthy range);
- •Current use of anabolic treatments (e.g. growth hormone or testosterone), anticholinesterase inhibitor (e.g. Aricept), hormone replacement (e.g. Estrogen), or anticoagulant therapies (note: aspirin use (≤ 81mg/day) is permitted);
- •Participation in another clinical trial, or has received an investigational product within 30 days prior to screening/enrollment;
- •Refuse to refrain from CoQ10 or alpha-lipoic acid while enrolled in the study.
- •Temporary Exclusion Criteria
- •Recent bacterial/viral infection (< 2 weeks);
- •Acute febrile illness in past 2 months;
- •High blood pressure (i.e. ≥ 140/90 mm Hg but ≤ 160/90) at the screening visit;
- •Major surgery or hip/knee replacement (< 6 months).
研究组 & 干预措施
Vegetable cellulose
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
干预措施: Vegetable cellulose (Other)
Vegetable cellulose
Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
干预措施: All groups (Other)
Resveratrol 1000 mg/day
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
干预措施: Resveratrol 1000 mg/day (Drug)
Resveratrol 1000 mg/day
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
干预措施: All groups (Other)
Resveratrol 1500 mg/day
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
干预措施: Resveratrol 1500 mg/day (Drug)
Resveratrol 1500 mg/day
Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
干预措施: All groups (Other)
结局指标
主要结局
Change From Baseline in Mitochondrial Respiration in Muscle
时间窗: Baseline to 90 Days
Change in mitochondrial respiration (State 3) in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days).
Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples
时间窗: Baseline to 90 Days
Change in citrate synthase (CS) enzymes in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days).
Change From Baseline in Mitochondrial DNA Content in Muscle Samples
时间窗: Baseline and 90 Days
Change in mitochondrial DNA content in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days).
Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples
时间窗: Baseline to 90 days
Change in cytochrome oxidase (COX) in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days).
次要结局
- Blood Glucose Level(Baseline to 90 Days)
- Physical Activity Levels(Baseline to 90 Days)
- Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels.(Baseline to 90 Days)
- Change From Baseline in PGC-1α Muscle Protein Levels(Baseline to 90 Days)
- Change From Baseline in Walking Speed.(Baseline to 90 Days)
- Change From Baseline in AMPK Muscle Protein Levels.(Baseline to 90 Days)
- Change From Baseline in Physical Performance(Baseline to 90 Days)
- Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels.(Baseline to 90 days)