Mitochondrial FunctionsNCT04919876
Phytochemicals on "Metabolic Aging" in Older Overweight Adults
A study testing fruit/vegetable supplement (FVS) in people with Mitochondrial Functions, run by Biofortis, Merieux NutriSciences at 1 site in United States.
Trial summary
Aging is a complex and inevitable biological process that is associated with numerous chronic health conditions and the development and progression of diseases. It is manifested partly by a progressive decline in fitness and an increase in death. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Functions
- What is being tested?
- fruit/vegetable supplement (FVS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy
- Age, ≥55 y old
- BMI, ≥27 and <35 kg/m2
- Consume a typical American diet, <3 servings of combined fruits and vegetables daily
- Waist:hip ratio >0.8 for women and >0.9 for men, and waist:height ratio ≥0.5
- Willing to consume study meals for 8 wk
- Do not have allergic reaction to plant foods
- Willing to take the assigned supplement for 6 wk
Who cannot join
- Unusual dietary pattern, including vegan/vegetarian
- Cigarette smoking and/or nicotine replacement use in the last 6 months
- Intend to be pregnant, pregnancy, and breastfeeding
- Use of medications known to change lipid metabolism
- Steroid use, except nasal and non-prescription topical treatments
- Active treatment for cancer of any type >1 y, except non-melanoma skin cancer
Show all 25Show fewer
- Have an immunodeficiency condition
- Use of immunosuppressive medications within the last 6 months
- Weekly alcoholic intake >14 drinks (168 oz beer, 56 oz wine, 14 oz hard liquor)
- Drugs known to influence fecal microbiota: Regular use of fiber supplements such as Metamucil, probiotics, prebiotics, laxatives, stool softeners, H2 blockers, proton pump inhibitors (PPI) or antacids.
- Antibiotic use within 3 months prior to or during study participation
- Colonoscopy or colonoscopy prep within 3 months prior to or during study
- Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
- History of a bilateral mastectomy with nodal dissection
- Consume ≥3 servings of fruits and vegetables daily one average
- Gastrointestinal diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease or inflammatory bowel disease which will be found based on the self-report during the screening visit
- Diabetes and/or use of diabetes medications
- Unstable thyroid disease or adjustment of thyroid medication in past 6 months
- Abnormal values of standard blood biochemistries that interfere with study outcomes based on study physician's discretion
- Infection or immunization within 30 days prior to study admission
- Use anticoagulants, such as heparin, warfarin (coumadin), or Plavix in past 6 months
- On or planning to be on a weight loss regimen
- Gain or loss of ≥5% body weight in the last 6 months
- Inability to refrain from ASA/NSAID/Tylenol use x 720 prior to study blood draws
- Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) prebiotics, probiotics or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements 30 days prior to enrollment and throughout the entire study may be considered eligible
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
Chery H Gilhooly, PhD, 617-556-3154, Cheryl.Gilhooly@tufts.edu
About this study
Official title: The Impact of a Phytochemical Supplement on "Metabolic Aging" in Older Overweight Adults Relative to Young Lean Adults
Aging is a complex and inevitable biological process that is associated with numerous chronic health conditions and the development and progression of diseases. It is manifested partly by a progressive decline in fitness and an increase in death. The key to healthy aging is a healthy lifestyle, including eating a variety of healthy foods and frequently participating in physical activities. Supplements made from widely consumed plant products have the potential for promoting healthy aging. However, more human data is required to substantiate this potential. Thus, the purpose of this study is to determine examining whether older adults taking a fruit/vegetable supplement for 6 weeks will have biochemical values of stool, blood, and urine similar to those of younger adults. The fruit/vegetable supplement contains a variety of vitamins and minerals and other nutrients that have been known to be beneficial to human health and many Americans may consume inadequate amounts in their daily diet. In order for us to understand how these nutrients may benefit health, we are interested in determining whether they can modify biochemical values of blood that occur in the body after taking the supplement for 6 weeks. We aim to have 40 older subjects and 20 younger subjects complete the trial. The enrolled subjects will consume prepackaged study meals for approximately 8 weeks and provide blood samples. The study meals will comprise foods most Americans eat every day. The older subjects, but not younger subjects, will take the assigned supplement. The younger subjects will consume the study meals for 2 weeks and provide one blood sample during the study.
Read the detailed description
Advanced age is associated with reduced mitochondrial capacity and altered metabolomic signatures relative to those at younger ages. We hypothesize that supplemental fruit and vegetable phytochemicals will slow or reverse signs of metabolic aging by enhancing mitochondrial capacity in older, overweight/obese adults as well as shift their metabolomic signature toward those of younger, leaner adults. To test this hypothesis, we will pursue the following specific aims in a controlled feeding trial to diminish the confounding effect of concurrent and confounding dietary factors.
Specific Aim 1: To determine the extent to which supplemental fruit and vegetable concentrates will shift the mitochondrial capacity of peripheral blood mononuclear cells in older, overweight older adults toward that of young, lean adults.
Specific Aim 2: To determine the extent to which supplemental fruit and vegetable concentrates will shift the plasma metabolomic signature of older, overweight adults toward that of young, lean adults.
The experimental design is a randomized, double-blind, placebo-controlled, parallel design, controlled feeding trial. This trial will enroll 40 older adults, as well as 20 younger adults to serve as a reference, to complete the study. They will be generally healthy. The older adults will be ≥55 y and have BMI >27.0 and <35 kg/m2, and the younger adults will be 18-30 y and have BMI >18.5 and <27 kg/m2. The older subjects will be randomized to receive either placebo (PLA) or fruit/vegetable supplement (FVS) for 6 weeks after a 2-wk run-in period. The younger adults serving as the reference group for the older subjects will only participate in the run-in period and will not receive any dietary supplements. During the whole study, including the run-in period, all subjects will consume provided meals. The total duration of the trial will be ~10 weeks for the older subjects, including screening, 2-wk run-in, and 6 wk of intervention, as well as ~4 weeks for the younger subjects including screening and 2-wk run-in. In addition to consuming the provided meals for 6 weeks, the older volunteers will take an assigned supplement daily. Blood samples of the older volunteers will be collected at the end of the run-in and the end of the 6-wk intervention. These same samples will only be collected from the younger volunteers at the end of the run-in period.
Older subjects will be randomly assigned to receive one of the supplements (PLA vs. FVS) after their eligibility is confirmed. A randomization scheme will be prepared by a biostatistician using a standardized computer program for two treatment groups using a parallel design.
The study supplements will be generously provided by Juice PLUS (Collierville, TN). A matching placebo product will be manufactured by the Juice PLUS under the FDA GMP guidelines. The main ingredient of the placebo will be microcrystalline cellulose-containing 0.5% magnesium stearate. The Juice PLUS products that will be used in this intervention have been marketed in the US. Microcrystalline cellulose and magnesium stearate have a GRAS status under FDA Code of Federal Regulations (CFR) title 21. FVS in a capsule form will be the combination of Juice Plus+ Garden Blend, Juice Plus+ Orchard Blend, and Juice Plus+ Berry Blend. All Juice Plus+ supplements contain a fine, granular powder, mainly from botanical ingredients. This powder is encapsulated in a size 00 gelatin capsule. These three formulas will be blended to produce a uniform brown powder and packaged into study opaque capsules.
Juice Plus+ Garden Blend consists of vegetable juice powder and pulp from carrot, parsley, beet, kale, broccoli, cabbage, spinach, oat, rice, and tomato; gelatin, glucomannan, calcium ascorbate, mixed tocopherols, calcium carbonate, garlic powder, Spirulina Pacifica, natural mixed carotenoids, natural enzyme blend, Lactobacillus acidophilus, folic acid. The powder looks pale green in color and smells like cabbage. Juice Plus+ Orchard Blend consists of fruit juice powder and pulp from apple, orange, pineapple, cranberry, peach, acerola cherry, beet, prune, date, and papaya; gelatin, calcium ascorbate, citrus pectin, citrus bioflavonoids, glucomannan, natural mixed carotenoids, natural enzyme blend, bromelain, papain, mixed tocopherols, Lactobacillus acidophilus, folic acid. The powder looks pink in color and smells like apple/cranberry. Juice Plus+ Berry Blend consists of fruit juice and pulp powder of Concord grape, blueberry, cranberry, blackberry, bilberry, raspberry, black currant, elderberry, cocoa powder, pomegranate powder, green tea, ginger root, grape seed, and artichoke leaf powder, gelatin, mixed tocopherols, calcium ascorbate, natural enzyme blend, silicon dioxide, vegetable-derived magnesium stearate, citrus bioflavonoids from tangerine, folic acid. The powder looks purple in color and smells faintly of berry and cocoa.
During the trial, older subjects will be required to attend 1 screening visit and 3 study visits over 10 weeks, and younger subjects will be required to attend 1 screening visit and 2 study visits over 4 weeks. An initial screening visit (Visit 1) is employed to obtain informed consent and determine each subject's eligibility. A blood sample will be collected only if the subject is fasting >12 hours. At Visit 2, subjects will begin to consume the provided meals for 2 weeks during the run-in period. At Visit 3, all subjects will be asked to arrive at the study site after fasting for >12 h, blood will be collected. For younger subjects, the study will complete at end of Visit 3. Older subjects will be randomly assigned to one of 2 supplements, starting on the next day of Visit 3 for 6 weeks. They will be instructed to take 3 capsules each with breakfast and dinner. At Visit 4 (final visit), older subjects will be asked to arrive at the study site after fasting for >12 h, blood will be collected for analyses.
Younger and older subjects will consume provided meals for 2 and 8 weeks. The study meals will be designed to be comparable to a diet that most average Americans are consuming. Subjects may consume the study meals longer than 2 or 8 weeks because of a visit scheduling conflict or other unexpected events.
- Conditions
- Mitochondrial Functions
- Being tested
- fruit/vegetable supplement (FVS), Placebo
- Keywords
- phytochemicals, fruit, vegetables, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruit/vegetable supplement (FVS)Dietary supplement
The supplement contains polyphenols, carotenoids, and other phytochemicals present in plant foods.
PlaceboDietary supplement
The product does not contain nutrients present in the FVS.
| Study group | Role | What they receive |
|---|---|---|
| fruit/vegetable supplement (FVS) | Experimental | The experimental product will be prepared by combing Juice Plus+ Garden Blend, Juice Plus+ Orchard Blend, and Juice Plus+ Berry Blend in an equal proportion. Receives: Dietary Supplement: fruit/vegetable supplement (FVS) |
| placebo | Placebo comparator | The placebo comprises microcrystalline cellulose and 0.5% magnesium stearate. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mitochondrial function
Targeted central carbon metabolomic in peripheral blood mononuclear cells
Measured: at end of 6-week intervention
Secondary outcomes (1)
metabolomics
non-targeting plasma metabolomics
Measured: at end of 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Nov 2016
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial FunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind, placebo-controlled, parallel design, controlled feeding trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biofortis, Merieux NutriSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Oliver Chen, Biofortis, Merieux NutriSciences
- Investigators
- Oliver Chen, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919876
- Sponsor's protocol ID
- 2920
- Status last verified
- Jul 2021
- First submitted
- 10 Apr 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Phytochemical Supplement on "Metabolic Aging" in Older Overweight Adults Relative to Young Lean Adults
- ClinicalTrials.gov ID
- NCT04919876
- Acronym / sponsor ID
- 2920
- Conditions
- Mitochondrial Functions
- Keywords
- phytochemicals, fruit, vegetables, older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Biofortis, Merieux NutriSciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aging is a complex and inevitable biological process that is associated with numerous chronic health conditions and the development and progression of diseases. It is manifested partly by a progressive decline in fitness and an increase in death. The key to healthy aging is a healthy lifestyle, including eating a variety of healthy foods and frequently participating in physical activities. Supplements made from widely consumed plant products have the potential for promoting healthy aging. However, more human data is required to substantiate this potential. Thus, the purpose of this study is to determine examining whether older adults taking a fruit/vegetable supplement for 6 weeks will have biochemical values of stool, blood, and urine similar to those of younger adults. The fruit/vegetable supplement contains a variety of vitamins and minerals and other nutrients that have been known to be beneficial to human health and many Americans may consume inadequate amounts in their daily diet. In order for us to understand how these nutrients may benefit health, we are interested in determining whether they can modify biochemical values of blood that occur in the body after taking the supplement for 6 weeks. We aim to have 40 older subjects and 20 younger subjects complete the trial. The enrolled subjects will consume prepackaged study meals for approximately 8 weeks and provide blood samples. The study meals will comprise foods most Americans eat every day. The older subjects, but not younger subjects, will take the assigned supplement. The younger subjects will consume the study meals for 2 weeks and provide one blood sample during the study.
Detailed description
Advanced age is associated with reduced mitochondrial capacity and altered metabolomic signatures relative to those at younger ages. We hypothesize that supplemental fruit and vegetable phytochemicals will slow or reverse signs of metabolic aging by enhancing mitochondrial capacity in older, overweight/obese adults as well as shift their metabolomic signature toward those of younger, leaner adults. To test this hypothesis, we will pursue the following specific aims in a controlled feeding trial to diminish the confounding effect of concurrent and confounding dietary factors.
Specific Aim 1: To determine the extent to which supplemental fruit and vegetable concentrates will shift the mitochondrial capacity of peripheral blood mononuclear cells in older, overweight older adults toward that of young, lean adults.
Specific Aim 2: To determine the extent to which supplemental fruit and vegetable concentrates will shift the plasma metabolomic signature of older, overweight adults toward that of young, lean adults.
The experimental design is a randomized, double-blind, placebo-controlled, parallel design, controlled feeding trial. This trial will enroll 40 older adults, as well as 20 younger adults to serve as a reference, to complete the study. They will be generally healthy. The older adults will be ≥55 y and have BMI >27.0 and <35 kg/m2, and the younger adults will be 18-30 y and have BMI >18.5 and <27 kg/m2. The older subjects will be randomized to receive either placebo (PLA) or fruit/vegetable supplement (FVS) for 6 weeks after a 2-wk run-in period. The younger adults serving as the reference group for the older subjects will only participate in the run-in period and will not receive any dietary supplements. During the whole study, including the run-in period, all subjects will consume provided meals. The total duration of the trial will be ~10 weeks for the older subjects, including screening, 2-wk run-in, and 6 wk of intervention, as well as ~4 weeks for the younger subjects including screening and 2-wk run-in. In addition to consuming the provided meals for 6 weeks, the older volunteers will take an assigned supplement daily. Blood samples of the older volunteers will be collected at the end of the run-in and the end of the 6-wk intervention. These same samples will only be collected from the younger volunteers at the end of the run-in period.
Older subjects will be randomly assigned to receive one of the supplements (PLA vs. FVS) after their eligibility is confirmed. A randomization scheme will be prepared by a biostatistician using a standardized computer program for two treatment groups using a parallel design.
The study supplements will be generously provided by Juice PLUS (Collierville, TN). A matching placebo product will be manufactured by the Juice PLUS under the FDA GMP guidelines. The main ingredient of the placebo will be microcrystalline cellulose-containing 0.5% magnesium stearate. The Juice PLUS products that will be used in this intervention have been marketed in the US. Microcrystalline cellulose and magnesium stearate have a GRAS status under FDA Code of Federal Regulations (CFR) title 21. FVS in a capsule form will be the combination of Juice Plus+ Garden Blend, Juice Plus+ Orchard Blend, and Juice Plus+ Berry Blend. All Juice Plus+ supplements contain a fine, granular powder, mainly from botanical ingredients. This powder is encapsulated in a size 00 gelatin capsule. These three formulas will be blended to produce a uniform brown powder and packaged into study opaque capsules.
Juice Plus+ Garden Blend consists of vegetable juice powder and pulp from carrot, parsley, beet, kale, broccoli, cabbage, spinach, oat, rice, and tomato; gelatin, glucomannan, calcium ascorbate, mixed tocopherols, calcium carbonate, garlic powder, Spirulina Pacifica, natural mixed carotenoids, natural enzyme blend, Lactobacillus acidophilus, folic acid. The powder looks pale green in color and smells like cabbage. Juice Plus+ Orchard Blend consists of fruit juice powder and pulp from apple, orange, pineapple, cranberry, peach, acerola cherry, beet, prune, date, and papaya; gelatin, calcium ascorbate, citrus pectin, citrus bioflavonoids, glucomannan, natural mixed carotenoids, natural enzyme blend, bromelain, papain, mixed tocopherols, Lactobacillus acidophilus, folic acid. The powder looks pink in color and smells like apple/cranberry. Juice Plus+ Berry Blend consists of fruit juice and pulp powder of Concord grape, blueberry, cranberry, blackberry, bilberry, raspberry, black currant, elderberry, cocoa powder, pomegranate powder, green tea, ginger root, grape seed, and artichoke leaf powder, gelatin, mixed tocopherols, calcium ascorbate, natural enzyme blend, silicon dioxide, vegetable-derived magnesium stearate, citrus bioflavonoids from tangerine, folic acid. The powder looks purple in color and smells faintly of berry and cocoa.
During the trial, older subjects will be required to attend 1 screening visit and 3 study visits over 10 weeks, and younger subjects will be required to attend 1 screening visit and 2 study visits over 4 weeks. An initial screening visit (Visit 1) is employed to obtain informed consent and determine each subject's eligibility. A blood sample will be collected only if the subject is fasting >12 hours. At Visit 2, subjects will begin to consume the provided meals for 2 weeks during the run-in period. At Visit 3, all subjects will be asked to arrive at the study site after fasting for >12 h, blood will be collected. For younger subjects, the study will complete at end of Visit 3. Older subjects will be randomly assigned to one of 2 supplements, starting on the next day of Visit 3 for 6 weeks. They will be instructed to take 3 capsules each with breakfast and dinner. At Visit 4 (final visit), older subjects will be asked to arrive at the study site after fasting for >12 h, blood will be collected for analyses.
Younger and older subjects will consume provided meals for 2 and 8 weeks. The study meals will be designed to be comparable to a diet that most average Americans are consuming. Subjects may consume the study meals longer than 2 or 8 weeks because of a visit scheduling conflict or other unexpected events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double blind, placebo-controlled, parallel design, controlled feeding trial
| Arm | Type | Receives |
|---|---|---|
| fruit/vegetable supplement (FVS) | Experimental | Dietary Supplement: fruit/vegetable supplement (FVS)The experimental product will be prepared by combing Juice Plus+ Garden Blend, Juice Plus+ Orchard Blend, and Juice Plus+ Berry Blend in an equal proportion. |
| placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo comprises microcrystalline cellulose and 0.5% magnesium stearate. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Generally healthy
- Age, ≥55 y old
- BMI, ≥27 and <35 kg/m2
- Consume a typical American diet, <3 servings of combined fruits and vegetables daily
- Waist:hip ratio >0.8 for women and >0.9 for men, and waist:height ratio ≥0.5
Key exclusion criteria (25 listed)
- Unusual dietary pattern, including vegan/vegetarian
- Cigarette smoking and/or nicotine replacement use in the last 6 months
- Intend to be pregnant, pregnancy, and breastfeeding
- Use of medications known to change lipid metabolism
- Steroid use, except nasal and non-prescription topical treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fruit/vegetable supplement (FVS)The supplement contains polyphenols, carotenoids, and other phytochemicals present in plant foods. | Dietary supplement | fruit/vegetable supplement (FVS) |
| PlaceboThe product does not contain nutrients present in the FVS. | Dietary supplement | placebo |
Primary outcome
mitochondrial function
Time frame: at end of 6-week intervention
Targeted central carbon metabolomic in peripheral blood mononuclear cells
1 secondary outcome
metabolomics
Time frame: at end of 6-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Chen, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fruit/vegetable supplement (FVS) in people with Mitochondrial Functions, run by Biofortis, Merieux NutriSciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Chen, PhD (6175563128, oliver.chen@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mitochondrial function (time frame: at end of 6-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.