DynapeniaPhase 1/2VitE-muscleNCT03708354
Tocotrienols for Skeletal Muscle Health
A Phase 1/2 study testing DeltaGold® Tocotrienol 70% in people with Dynapenia and Postmenopausal Women, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Sarcopenia, defined as a reduction in muscle mass and strength, is a major health concern for postmenopausal women. Evidence suggests that lowering inflammation levels is an important strategy to help mitigate age-related muscle dysfunction and loss. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dynapenia, Postmenopausal Women
- What is being tested?
- DeltaGold® Tocotrienol 70%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 31 Dec 2022
- Phase
- Phase 1/2
- 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 60 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (60-85 yr) not on hormone replacement therapy in the past year.
- Normal liver, kidney, thyroid function (TSH), serum 25-OH vitamin D (≥ 20 ng/ml)-sent to Quest Diagnostic Laboratory.
- Grip strength weakness (<20 kg).
- Sedentary -evaluated by using self-administered International Physical Activity Questionnaire (IPAQ) short form.
Who cannot join
- Serious chronic disease (e.g., unstable CVD, uncontrolled diabetes, uncontrolled hypertension, active cancer, Parkinson's disease).
- Taking hormone replacement therapy within 3 months before study starts.
- Taking medications (i.e., steroids) within 3 months before study starts, since steroids could affect muscle function.
- Taking supplements (i.e., fish oil) that have anti-inflammatory action during the past 3 months.
- Having dementia or other medical/eating disorder (i.e. currently receiving an appetite stimulant).
- Self-report of >10% body weight loss in the past month.
- Taking anticoagulants that may interact with tocotrienols.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Tocotrienols Supplementation for Postmenopausal Women With Low Muscle Strength
Sarcopenia, defined as a reduction in muscle mass and strength, is a major health concern for postmenopausal women. Evidence suggests that lowering inflammation levels is an important strategy to help mitigate age-related muscle dysfunction and loss. In this pilot study, the investigators will study a tocotrienol (vitamin-E isomer) intervention for feasibility and quantify its effects on postmenopausal women with low muscle strength. A double blind, placebo controlled trial will be conducted on fifty-two qualified subjects. The participants will be assigned to placebo or tocotrienols for 24 weeks. All participants will receive an Omron Alvita Optimized Pedometer. The investigators will measure muscular endurance, strength, and size and gut microbiome profiles at 0, 12, and 24 weeks. In addition, the investigators will measure serum and muscle inflammatory levels at 0 and 24 weeks. All data will be analyzed statistically at p<0.05.
Read the detailed description
Sarcopenia is a major health issue in postmenopausal women (PMW). The long-term goal is to develop a new strategy featuring a dietary supplement for alleviating sarcopenia in postmenopausal women. The objective is to test a dietary supplement intervention (delta-tocotrienols, TT) for feasibility, and to quantitatively assess its effects on postmenopausal women with sarcopenia. Due to the limited budget, the investigators will not assess appendicular muscle mass in this pilot study and will focus on muscle strength and function. The central hypotheses are that (i) TT supplementation will alleviate age-associated skeletal muscular dysfunction of postmenopausal women with low muscle strength, and (ii) such changes in skeletal muscle are associated with lowered oxidative stress and inflammation wherein the targets are oxylipins (OxL) and endocannabinoids (eCB), and possible modification of gut microbiota. This is a randomized double-blinded placebo-controlled trial. Fifty-two qualified subjects will be assigned to placebo or TT for 24 weeks. There are 4 specific aims (SA) in this study. SA 1 is to evaluate the effects of TT intervention on endurance, strength, function and size of the lower-extremity musculature in PMW with low muscle strength. SA 2 is to measure the effects of TT intervention on oxidative stress and inflammatory levels. SA 3 is to measure the effects of TT intervention on inflammatory OxL and eCB levels in plasma and muscle tissue. SA 4 is to evaluate the effects of TT intervention on abundance and composition of intestinal bacterial in feces. The outcome measures of SA 1 will be assessed at the baseline, after 12 and 24 weeks. The outcome measures of SA 2, SA 3, and SA 4 will be assessed at the baseline and after 24 weeks. In addition, at 0 and 24 weeks, the investigators will monitor (i) compliance by pill count and (ii) changes in lifestyle throughout the study via food intake surveys and physical activity surveys. Descriptive statistics, bivariate tests, and general/generalized linear mixed modeling will be used for the quantitative analysis on the effects of the TT intervention.
- Conditions
- Dynapenia, Postmenopausal Women
- Being tested
- placebo softgel, DeltaGold® Tocotrienol 70%
- Keywords
- skeletal muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo softgelDrug
Also called olive oil
One 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels.
DeltaGold® Tocotrienol 70%Drug
Also called tocotrienol
Each TT softgel (DeltaGold® Tocotrienol 70%) contains 430 mg TT (90% δ-TT+10% γ-TT) with a 70% purity, representing 300 mg TT.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | One 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels. Receives: Drug: placebo softgel |
| Intervention | Active comparator | One 430 mg tocotrienol softgel daily for 24 weeks. Each tocotrienol softgel (DeltaGold® Tocotrienol 70%) contains 430 mg tocotrienol (90% δ-tocotrienol+10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol. Receives: Drug: DeltaGold® Tocotrienol 70% |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower-body muscle endurance
assessed by 6-min walk test
Measured: 24 weeks
Secondary outcomes (11)
8-OHdG
urine 8-hydroxy-2'-deoxyguanosine
Measured: 24 weeks
oxylipins
oxylipins levels in plamsa and skeletal muscle biopsy
Measured: 24 weeks
gut microbiome
abundance and composition of intestine microbiome in feces
Measured: 24 weeks
handgrip strength
assessed by a hand dynamometer
Measured: 24 weels
lower-body muscle strength
assessed by isometric knee extension muscle strength
Measured: 24 weeks
functional performance
assessed by Time Up and Go test
Measured: 24 weeks
Muscle size of the lower-extremity musculature
cross-sectional area of the rectus femoris assessed using a diagnostic ultrasound device
Measured: 24 weeks
F2-isoprostanes
F2-isoprostanes in urine
Measured: 24 weeks
TNF-alpha
Transforming necrosis factor-alpha in urine
Measured: 24 weeks
hs-CRP
high sensitivity C-reactive protein
Measured: 24 weeks
endocannabinoid
endocannabinoid levels in plasma and muscle biopsy
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start15 Apr 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Difficulties in Recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DynapeniaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- dietary supplement
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chwan-Li Shen, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708354
- Sponsor's protocol ID
- L19-011
- Acronym
- VitE-muscle
- Status last verified
- Feb 2022
- First submitted
- 10 Oct 2018
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocotrienols Supplementation for Postmenopausal Women With Low Muscle Strength
- ClinicalTrials.gov ID
- NCT03708354
- Acronym / sponsor ID
- VitE-muscle / L19-011
- Conditions
- Dynapenia, Postmenopausal Women
- Keywords
- skeletal muscle strength
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties in Recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Oct 2018 (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.
Sarcopenia, defined as a reduction in muscle mass and strength, is a major health concern for postmenopausal women. Evidence suggests that lowering inflammation levels is an important strategy to help mitigate age-related muscle dysfunction and loss. In this pilot study, the investigators will study a tocotrienol (vitamin-E isomer) intervention for feasibility and quantify its effects on postmenopausal women with low muscle strength. A double blind, placebo controlled trial will be conducted on fifty-two qualified subjects. The participants will be assigned to placebo or tocotrienols for 24 weeks. All participants will receive an Omron Alvita Optimized Pedometer. The investigators will measure muscular endurance, strength, and size and gut microbiome profiles at 0, 12, and 24 weeks. In addition, the investigators will measure serum and muscle inflammatory levels at 0 and 24 weeks. All data will be analyzed statistically at p<0.05.
Detailed description
Sarcopenia is a major health issue in postmenopausal women (PMW). The long-term goal is to develop a new strategy featuring a dietary supplement for alleviating sarcopenia in postmenopausal women. The objective is to test a dietary supplement intervention (delta-tocotrienols, TT) for feasibility, and to quantitatively assess its effects on postmenopausal women with sarcopenia. Due to the limited budget, the investigators will not assess appendicular muscle mass in this pilot study and will focus on muscle strength and function. The central hypotheses are that (i) TT supplementation will alleviate age-associated skeletal muscular dysfunction of postmenopausal women with low muscle strength, and (ii) such changes in skeletal muscle are associated with lowered oxidative stress and inflammation wherein the targets are oxylipins (OxL) and endocannabinoids (eCB), and possible modification of gut microbiota. This is a randomized double-blinded placebo-controlled trial. Fifty-two qualified subjects will be assigned to placebo or TT for 24 weeks. There are 4 specific aims (SA) in this study. SA 1 is to evaluate the effects of TT intervention on endurance, strength, function and size of the lower-extremity musculature in PMW with low muscle strength. SA 2 is to measure the effects of TT intervention on oxidative stress and inflammatory levels. SA 3 is to measure the effects of TT intervention on inflammatory OxL and eCB levels in plasma and muscle tissue. SA 4 is to evaluate the effects of TT intervention on abundance and composition of intestinal bacterial in feces. The outcome measures of SA 1 will be assessed at the baseline, after 12 and 24 weeks. The outcome measures of SA 2, SA 3, and SA 4 will be assessed at the baseline and after 24 weeks. In addition, at 0 and 24 weeks, the investigators will monitor (i) compliance by pill count and (ii) changes in lifestyle throughout the study via food intake surveys and physical activity surveys. Descriptive statistics, bivariate tests, and general/generalized linear mixed modeling will be used for the quantitative analysis on the effects of the TT intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- dietary supplement
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: placebo softgelOne 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels. |
| Intervention | Active comparator | Drug: DeltaGold® Tocotrienol 70%One 430 mg tocotrienol softgel daily for 24 weeks. Each tocotrienol softgel (DeltaGold® Tocotrienol 70%) contains 430 mg tocotrienol (90% δ-tocotrienol+10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women (60-85 yr) not on hormone replacement therapy in the past year.
- Normal liver, kidney, thyroid function (TSH), serum 25-OH vitamin D (≥ 20 ng/ml)-sent to Quest Diagnostic Laboratory.
- Grip strength weakness (<20 kg).
- Sedentary -evaluated by using self-administered International Physical Activity Questionnaire (IPAQ) short form.
Key exclusion criteria (7 listed)
- Serious chronic disease (e.g., unstable CVD, uncontrolled diabetes, uncontrolled hypertension, active cancer, Parkinson's disease).
- Taking hormone replacement therapy within 3 months before study starts.
- Taking medications (i.e., steroids) within 3 months before study starts, since steroids could affect muscle function.
- Taking supplements (i.e., fish oil) that have anti-inflammatory action during the past 3 months.
- Having dementia or other medical/eating disorder (i.e. currently receiving an appetite stimulant).
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 |
|---|---|---|
| placebo softgelAlso: olive oilOne 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels. | Drug | Control |
| DeltaGold® Tocotrienol 70%Also: tocotrienolEach TT softgel (DeltaGold® Tocotrienol 70%) contains 430 mg TT (90% δ-TT+10% γ-TT) with a 70% purity, representing 300 mg TT. | Drug | Intervention |
Primary outcome
lower-body muscle endurance
Time frame: 24 weeks
assessed by 6-min walk test
11 secondary outcomes
8-OHdG
Time frame: 24 weeks
oxylipins
Time frame: 24 weeks
gut microbiome
Time frame: 24 weeks
handgrip strength
Time frame: 24 weels
lower-body muscle strength
Time frame: 24 weeks
functional performance
Time frame: 24 weeks
Muscle size of the lower-extremity musculature
Time frame: 24 weeks
F2-isoprostanes
Time frame: 24 weeks
TNF-alpha
Time frame: 24 weeks
hs-CRP
Time frame: 24 weeks
endocannabinoid
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- 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.
Chwan-Li Shen, PhD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DeltaGold® Tocotrienol 70% in people with Dynapenia and Postmenopausal Women, run by Texas Tech University Health Sciences Center 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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Feb 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower-body muscle endurance (time frame: 24 weeks). 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 18 Feb 2022.