Energy MetabolismNCT03701867
Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women
A study testing Metabolic Flexibility Tests in people with Energy Metabolism, run by Abbott Nutrition at 1 site in United States.
Trial summary
This study will explore differences in energy metabolism and metabolic flexibility under various conditions in older men and women. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism
- What is being tested?
- Metabolic Flexibility Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 22 Jul 2019
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Body mass index (BMI) >20.0 and <39.0 kg/m2
- Ambulatory (may use assistance device e.g., cane, walker)
- Not a current smoker (within past 10 years)
- Low or moderate risk based on the responses from the AHA/ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
- Normal muscle mass and strength/performance or sarcopenia included in low muscle mass and low grip strength
- If on thyroid medication or hormone replacement therapy, has been on a constant dosage for at least 2 months prior to Screening Visit
- Willingness to follow protocol as described
- Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to any participation in the study
Who cannot join
- Active/treated disease, under the care of a physician, for the following: metabolic/endocrine (diabetes), hepatic, or renal disease, myocardial infarction, peripheral vascular disease, respiratory or neuromuscular disease
- Participates in a resistance exercise program
- Poor appetite with recent unexplained weight loss over the past 6 months
- Current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks.
- Active malignancy, excluding carcinoma in-situ of the cervix, cutaneous malignancies (basal cell carcinoma, squamous cell carcinoma, except melanoma)
- Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV
Show all 11Show fewer
- Taking medications/dietary supplements or substances that could profoundly modulate metabolism in the opinion of the principal investigator or study physician, Exceptions for multi-vitamin/mineral supplement, topical or optical steroids and short-term use (less than two weeks) of dexamethasone
- Allergy or intolerance to any foods
- History of gastrointestinal disease, or surgeries, gastroparesis, or taking medications that are known in the opinion of the PI or study physician to interfere with consumption/digestion/absorption of nutrients
- Eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with compliance with study protocol procedures in the opinion of the principal investigator or study physician
- Participant in a concomitant AN trial or trial of a non-registered drug (or is within the 30 day follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Explore Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women
This study will explore differences in energy metabolism and metabolic flexibility under various conditions in older men and women.
- Conditions
- Energy Metabolism
- Being tested
- Metabolic Flexibility Tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic Flexibility TestsOther
Energy Metabolism, Oxygenation, Body Composition, Blood Samples
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Flexibility Tests Group | Experimental | Not described Receives: Other: Metabolic Flexibility Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Quotient
Ratio of macronutrient oxidation
Measured: Baseline to 270 minutes
Secondary outcomes (6)
Blood Biochemistries - Glucose
Venous blood sample
Measured: Baseline to 270 minutes
Blood Biochemistries - Insulin
Venous blood sample
Measured: Baseline to 270 minutes
Blood Biochemistries - Amino Acids
Venous blood sample
Measured: Baseline to 270 minutes
Blood Biochemistries - Fatty Acids
Venous blood sample
Measured: Baseline to 270 minutes
Muscle Oxygenation
Near Infrared Spectroscopy
Measured: Baseline to 270 minutes
Muscle Fatigue
Electromyography
Measured: Baseline to 270 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start14 Nov 2018
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Energy MetabolismStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikkie Mustad, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701867
- Sponsor's protocol ID
- BL39
- Status last verified
- Aug 2019
- First submitted
- 21 Sep 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shoemaker ME, Pereira SL, Mustad VA, Gillen ZM, McKay BD, Lopez-Pedrosa JM, Rueda R, Cramer JT. A pilot study evaluating differences in muscle tissue saturation and blood flow between older adults with and without sarcopenia. Front Endocrinol (Lausanne). 2025 Aug 13;16:1644712. doi: 10.3389/fendo.2025.1644712. eCollection 2025.
PubMed 41070343Shoemaker ME, Pereira SL, Mustad VA, Gillen ZM, McKay BD, Lopez-Pedrosa JM, Rueda R, Cramer JT. Differences in muscle energy metabolism and metabolic flexibility between sarcopenic and nonsarcopenic older adults. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):1224-1237. doi: 10.1002/jcsm.12932. Epub 2022 Feb 17.
PubMed 35178889
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Explore Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women
- ClinicalTrials.gov ID
- NCT03701867
- Acronym / sponsor ID
- BL39
- Conditions
- Energy Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 10 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.
This study will explore differences in energy metabolism and metabolic flexibility under various conditions in older men and women.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic Flexibility Tests Group | Experimental | Other: Metabolic Flexibility Tests |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) >20.0 and <39.0 kg/m2
- Ambulatory (may use assistance device e.g., cane, walker)
- Not a current smoker (within past 10 years)
- Low or moderate risk based on the responses from the AHA/ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
- Normal muscle mass and strength/performance or sarcopenia included in low muscle mass and low grip strength
Key exclusion criteria (11 listed)
- Active/treated disease, under the care of a physician, for the following: metabolic/endocrine (diabetes), hepatic, or renal disease, myocardial infarction, peripheral vascular disease, respiratory or neuromuscular disease
- Participates in a resistance exercise program
- Poor appetite with recent unexplained weight loss over the past 6 months
- Current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks.
- Active malignancy, excluding carcinoma in-situ of the cervix, cutaneous malignancies (basal cell carcinoma, squamous cell carcinoma, except melanoma)
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 |
|---|---|---|
| Metabolic Flexibility TestsEnergy Metabolism, Oxygenation, Body Composition, Blood Samples | Other | Metabolic Flexibility Tests Group |
Primary outcome
Respiratory Quotient
Time frame: Baseline to 270 minutes
Ratio of macronutrient oxidation
6 secondary outcomes
Blood Biochemistries - Glucose
Time frame: Baseline to 270 minutes
Blood Biochemistries - Insulin
Time frame: Baseline to 270 minutes
Blood Biochemistries - Amino Acids
Time frame: Baseline to 270 minutes
Blood Biochemistries - Fatty Acids
Time frame: Baseline to 270 minutes
Muscle Oxygenation
Time frame: Baseline to 270 minutes
Muscle Fatigue
Time frame: Baseline to 270 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 41070343Shoemaker ME, Pereira SL, Mustad VA, Gillen ZM, McKay BD, Lopez-Pedrosa JM, Rueda R, Cramer JT. A pilot study evaluating differences in muscle tissue saturation and blood flow between older adults with and without sarcopenia. Front Endocrinol (Lausanne). 2025 Aug 13;16:1644712. doi: 10.3389/fendo.2025.1644712. eCollection 2025.
- Derived from this study: PubMed 35178889Shoemaker ME, Pereira SL, Mustad VA, Gillen ZM, McKay BD, Lopez-Pedrosa JM, Rueda R, Cramer JT. Differences in muscle energy metabolism and metabolic flexibility between sarcopenic and nonsarcopenic older adults. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):1224-1237. doi: 10.1002/jcsm.12932. Epub 2022 Feb 17.
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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.
Vikkie Mustad, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic Flexibility Tests in people with Energy Metabolism, run by Abbott Nutrition 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 11 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: finished, as of the sponsor's last update on 28 Aug 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respiratory Quotient (time frame: Baseline to 270 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701867, which also lists 2 linked publications.
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 28 Aug 2019.