InflammationPhase 2ENRGISENCT02676466

The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study

A Phase 2 study testing Omega-3 fish oil and Losartan in people with Inflammation, run by University of Florida at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Inflammation
What is being tested?: Omega-3 fish oil and Losartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 289 participants
Where: 5 sitesUnited States
Study dates: 26 Apr 2016to 22 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Men and women age >70 years
Self-reported difficulty walking ¼ of a mile or climbing a flight of stairs
Walking speed <1 meters per second and >0.44 meters per second on the 4 meter walk at usual pace. A walking speed of <0.44 meters per second would not be compatible with completing the 400 meter walk in 15 minutes. (In the pilot phase we explore the feasibility of recruiting at least 50% of participants who have a baseline walking speed of <0.80 meters per second and >0.44 meters per second)
Able to complete the 400 meter walk test within 15 minutes without sitting or the help of another person and without a walker, a cane is allowed
Blood level IL-6 >2.5 pg/ml and <30 pg/ml.
Willingness to be randomized to the intervention groups

Who cannot join

Failure or inability to provide informed consent
Lives in a nursing home; persons living in assisted or independent housing are not excluded
Self-reported inability to walk one block
Significant cognitive impairment, defined as a known diagnosis of dementia, or a Mini-Mental State Exam (MMSE) score <24 (<23 for racial/ethnic minorities or participants with less than 9 years of education)
Unable to communicate because of severe hearing loss or speech disorder
Neurological conditions that are causing impaired muscle function or mobility (may include stroke with residual paresis, paralysis, neuropathy, Parkinson disease, or multiple sclerosis)

Show all 42Show fewer

Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, known active inflammatory or autoimmune disease (e.g. rheumatoid arthritis, lupus, Crohn's disease, HIV)
Terminal illness with life expectancy less than 12 months
Severe pulmonary disease, requiring either steroid pills or injections
Other significant co-morbid disease that in the opinion of the field center PI would impair ability to participate in the trial, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia), excessive alcohol use (>14 drinks per week); drug addiction; treatment for cancer (radiation or chemotherapy) within the past 1 year; or other conditions
Lives outside of the study site or is planning to move out of the area in next 1 year or leave the area for >3 months during the next year
Exclusion criteria that apply only to those who receive losartan:
Intolerance or allergy to Angiotensin II Receptor Blockers (ARBs)
Known bilateral renal artery stenosis or liver cirrhosis
Hypotension Systolic Blood Pressure<110 or Diastolic Blood Pressure<60 mmHg
Serum potassium ≥5.0 mEq/L
Use of lithium salts
eGFR <15
Congestive heart failure with ejection fraction < 40%
Exclusion criteria that apply only to those who receive ω-3:
Intolerance or allergy to ω-3 or fish/shellfish
Fatty fish intake >2 servings per week on average
History of paroxysmal or persistent atrial fibrillation
To maintain blinding, those who are not eligible to receive any active treatment (ω-3 or losartan) are excluded
Temporary exclusion criteria
Myocardial infarction, coronary artery bypass grafting (CABG), or valve replacement within past 6 months;
Pulmonary embolism or deep venous thrombosis within past 6 months;
Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
Physical therapy for gait, balance, or other lower extremity training within the past 2 months;
Severe hypertension, e.g., Systolic Blood Pressure > 200, or Diastolic Blood Pressure> 110 mmHg;
Hemoglobin <10 g/dL
Participation in another intervention trial within 3 months; participation in an observational study may be permitted;
Current smoking (within 6 months),
Acute infection (urinary, respiratory, other) or hospitalization within 1 month
Exclusion criteria that apply only to those who receive losartan:
Use of Angiotensin-Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) within 2 months
Use of aliskiren within 2 months in patients with type 2 diabetes or renal impairment with Estimated Glomerular Filtration Rate (eGFR)<60
Use of potassium sparing diuretics, other medications with potassium sparing properties (such as but not limited to spironolactone or eplerenone) potassium supplements, and salt substitutes containing potassium within 1 week
Transaminases >twice upper limit of normal to exclude participants with impaired liver function
Exclusion criteria that apply only to those who receive ω-3:
Use of ω-3 within 2 months

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Tufts University
Boston, Massachusetts, 02111
Northwestern University
Chicago, Illinois, 60611
University of Florida
Gainesville, Florida, 32611
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Wake Forest University
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability.

Read the detailed description

Growing evidence shows that low-grade chronic inflammation, characterized by elevations in plasma C-reactive protein, tumor necrosis factor alpha, and particularly Interleukin-6 (IL-6), is an independent risk factor of disability, impaired mobility, and lower walking speed. Low-grade chronic inflammation is a modifiable risk factor. However, it is unknown whether interventions that reduce the levels of inflammatory markers per se improve mobility, or avert decline in mobility in older persons.

To address this gap in evidence the investigators are conducting the randomized clinical trial ENRGISE (ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study to test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability. We have maximized the public health impact by selecting interventions that are safe, tolerable, acceptable, and affordable for vulnerable older persons. Specifically, in this trial the investigators test the efficacy verus placebo of the angiotensin receptor blocker losartan and omega-3 polyunsaturated fatty acids in the form of fish oil, alone and in combination. Both angiotensin receptor blockers and omega-3 polyunsaturated fatty acids have shown to reduce IL-6 in clinical trials and preliminary data suggest that they may improve physical function.

Recruitment will include the older persons who are at risk for, or with, mobility impairment, as measured by slow gait speed and self-reported mobility difficulty, and who have elevated levels of IL-6, the marker most consistently associated with mobility limitations. Preliminary data regarding feasibility need to be gathered before such a trial can be effectively designed and implemented. We conduct The ENRGISE Pilot Study to assess the effects of the interventions on several inflammatory markers, walking speed, physical function and strength. This allows us to refine the design, recruitment yields, target population, adherence, retention, tolerability, sample-size, and cost for the main ENRGISE trial.

Conditions: Inflammation
Being tested: Omega-3 fish oil, Losartan, Corn Oil (Fish oil Placebo), Cellulose Based (Losartan Placebo)
Keywords: Mobility
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega-3 fish oilDietary supplement
The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
LosartanDrug
Also called Cozaar
The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
Corn Oil (Fish oil Placebo)Other
Also called Fish oil Placebo
The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo)Other
Also called Losartan Placebo
The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.

Study groups in NCT02676466
Study group	Role	What they receive
Fish oil Active	Experimental	This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Receives: Dietary Supplement: Omega-3 fish oil
Fish oil Placebo	Placebo comparator	This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Receives: Other: Corn Oil (Fish oil Placebo)
Losartan Active	Active comparator	This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Receives: Drug: Losartan
Losartan Placebo	Placebo comparator	This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Receives: Other: Cellulose Based (Losartan Placebo)
Fish oil Active + Losartan Active	Active comparator	This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Receives: Dietary Supplement: Omega-3 fish oil; Drug: Losartan
Fish oil Active + Losartan Placebo	Other	This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Receives: Dietary Supplement: Omega-3 fish oil; Other: Cellulose Based (Losartan Placebo)
Fish oil Placebo + Losartan Active	Other	This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Receives: Drug: Losartan; Other: Corn Oil (Fish oil Placebo)
Fish oil Placebo + Losartan Placebo	Other	This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Receives: Other: Corn Oil (Fish oil Placebo); Other: Cellulose Based (Losartan Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in the Interleukin-6 Level Between Groups
Changes in the Interleukin-6 Level Between the Groups
Measured: Changes from baseline to month 12
Number of Participants Experiencing Major Mobility Disability
The 400 meter walk test at usual pace is used to evaluate major mobility disability (MMD), defined as the inability to walk ¼ mile or 400 meters.
Measured: 12 months

Secondary outcomes (5)

Short Physical Performance Battery (SPPB)
A low score on the SPPB based on 4 m walk, balance \& chair stands tests is a risk factor for disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The summary score and components of the SPPB have good reliability (ICCs range from 0.88 to 0.92). Higher scores are better. Range 0-12.
Measured: 12 months
Number of Participants Exhibiting Frailty
Frailty will be characterized with Fried criteria developed by Fried et al. that employ self-reported exhaustion, unintentional weight loss, low energy expenditure, slow gait speed, and weak grip strength. Those with >3 of the 5 factors are judged to be frail, those with 1 or 2 factors as pre-frail, and those with no factors as non-frail.
Measured: 12 months
Isometric Hand Grip Strength
The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. Scoring will be taken from the best results of 3 trials. Males scores range from 88 pounds as very poor to 141 pounds as excellent with an average of 105-113 pounds. Females scores range from 44 pounds as very poor to 84 pounds as excellent with an average of 57-65 pounds.
Measured: 12 months
Peak Torque of the Knee Extensor and Flexor Muscles
Peak torque was measured at a rotational speed of 60 degrees per second using a commercially-available Isokinetic Dynamometer (Biodex). Torque was measured during maximal knee extension and flexion reported in Newton Meters.
Measured: month 12
Short Form Health Survey (SF-36) - Physical Component Score
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Range: 0-100. A lower score indicates more disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 201622 Jun 2018

First posted8 Feb 2016 (estimated)
Study start26 Apr 2016
Primary completion22 Jun 2018
Study completion22 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InflammationStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02676466
Sponsor's protocol ID: IRB201500894 - A-N
Other IDs: U01AG050499
Acronym: ENRGISE
Status last verified: Dec 2019
First submitted: 3 Feb 2016
Last updated: 7 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The investigator will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for ENRGISE study approved research purposes and not to identify any individual human participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Publications

Manini TM, Anton SD, Beavers DP, Cauley JA, Espeland MA, Fielding RA, Kritchevsky SB, Leeuwenburgh C, Lewis KH, Liu C, McDermott MM, Miller ME, Tracy RP, Walston JD, Radziszewska B, Lu J, Stowe C, Wu S, Newman AB, Ambrosius WT, Pahor M; ENRGISE Pilot study investigators. ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design. J Am Geriatr Soc. 2017 Sep;65(9):1961-1968. doi: 10.1111/jgs.14965. Epub 2017 Jul 22.
PubMed 28734043
Pahor M, Anton SD, Beavers DP, Cauley JA, Fielding RA, Kritchevsky SB, Leeuwenburgh C, Lewis KH, Liu CK, Lovato LC, Lu J, Manini TM, McDermott MM, Miller ME, Newman AB, Radziszewska B, Stowe CL, Tracy RP, Walkup MP, Wu SS, Ambrosius WT. Effect of Losartan and Fish Oil on Plasma IL-6 and Mobility in Older Persons. The ENRGISE Pilot Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1612-1619. doi: 10.1093/gerona/gly277.
PubMed 30541065

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
ClinicalTrials.gov ID: NCT02676466
Acronym / sponsor ID: ENRGISE / IRB201500894 - A-N
Conditions: Inflammation
Keywords: Mobility
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 289 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Abbott
Study start: 26 Apr 2016 (actual)
Primary completion: 22 Jun 2018 (actual)
Study completion: 22 Jun 2018 (actual)
First posted: 8 Feb 2016 (estimated)
Results: Posted 13 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Fish oil Active	Experimental	Dietary Supplement: Omega-3 fish oilThis group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Fish oil Placebo	Placebo comparator	Other: Corn Oil (Fish oil Placebo)This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Losartan Active	Active comparator	Drug: LosartanThis group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan Placebo	Placebo comparator	Other: Cellulose Based (Losartan Placebo)This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Fish oil Active + Losartan Active	Active comparator	Dietary Supplement: Omega-3 fish oil, Drug: LosartanThis group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Fish oil Active + Losartan Placebo	Other	Dietary Supplement: Omega-3 fish oil, Other: Cellulose Based (Losartan Placebo)This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Fish oil Placebo + Losartan Active	Other	Drug: Losartan, Other: Corn Oil (Fish oil Placebo)This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Fish oil Placebo + Losartan Placebo	Other	Other: Corn Oil (Fish oil Placebo), Other: Cellulose Based (Losartan Placebo)This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

Men and women age >70 years
Self-reported difficulty walking ¼ of a mile or climbing a flight of stairs
Walking speed <1 meters per second and >0.44 meters per second on the 4 meter walk at usual pace. A walking speed of <0.44 meters per second would not be compatible with completing the 400 meter walk in 15 minutes. (In the pilot phase we explore the feasibility of recruiting at least 50% of participants who have a baseline walking speed of <0.80 meters per second and >0.44 meters per second)
Able to complete the 400 meter walk test within 15 minutes without sitting or the help of another person and without a walker, a cane is allowed
Blood level IL-6 >2.5 pg/ml and <30 pg/ml.

Key exclusion criteria (42 listed)

Failure or inability to provide informed consent
Lives in a nursing home; persons living in assisted or independent housing are not excluded
Self-reported inability to walk one block
Significant cognitive impairment, defined as a known diagnosis of dementia, or a Mini-Mental State Exam (MMSE) score <24 (<23 for racial/ethnic minorities or participants with less than 9 years of education)
Unable to communicate because of severe hearing loss or speech disorder

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
Omega-3 fish oilThe Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.	Dietary supplement	Fish oil Active, Fish oil Active + Losartan Active, Fish oil Active + Losartan Placebo
LosartanAlso: CozaarThe Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.	Drug	Fish oil Active + Losartan Active, Fish oil Placebo + Losartan Active, Losartan Active
Corn Oil (Fish oil Placebo)Also: Fish oil PlaceboThe corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.	Other	Fish oil Placebo, Fish oil Placebo + Losartan Active, Fish oil Placebo + Losartan Placebo
Cellulose Based (Losartan Placebo)Also: Losartan PlaceboThe placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.	Other	Fish oil Active + Losartan Placebo, Fish oil Placebo + Losartan Placebo, Losartan Placebo

Primary outcome

Changes in the Interleukin-6 Level Between Groups
Time frame: Changes from baseline to month 12
Changes in the Interleukin-6 Level Between the Groups
Number of Participants Experiencing Major Mobility Disability
Time frame: 12 months
The 400 meter walk test at usual pace is used to evaluate major mobility disability (MMD), defined as the inability to walk ¼ mile or 400 meters.

5 secondary outcomes

Short Physical Performance Battery (SPPB)
Time frame: 12 months
Number of Participants Exhibiting Frailty
Time frame: 12 months
Isometric Hand Grip Strength
Time frame: 12 months
Peak Torque of the Knee Extensor and Flexor Muscles
Time frame: month 12
Short Form Health Survey (SF-36) - Physical Component Score
Time frame: month 12

Results and safety

Results posted to the registry on 13 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fish Oil Active	109	105
Fish Oil Placebo	71	66
Losartan Active	26	24
Losartan Placebo	17	17
Fish Oil Active + Losartan Active	26	23
Fish Oil Active + Losartan Placebo	13	12
Fish Oil Placebo + Losartan Active	13	12
Fish Oil Placebo + Losartan Placebo	14	13

Primary outcome: Changes in the Interleukin-6 Level Between Groups

Time frame: Changes from baseline to month 12. Mean (Standard Deviation). Unit: pg/ml

Measure	Fish Oil Active n = 109	Fish Oil Placebo n = 71	Losartan Active n = 26	Losartan Placebo n = 17	Fish Oil Active + Losartan Active n = 26	Fish Oil Active + Losartan Placebo n = 13	Fish Oil Placebo + Losartan Active n = 13	Fish Oil Placebo + Losartan Placebo n = 14
Value	0 (2.4)	-0.1 (2.7)	-0.6 (1.0)	3.8 (10.0)	-0.3 (1.0)	-0.2 (1.8)	-1.4 (0.9)	-1.0 (2.8)

Primary outcome: Number of Participants Experiencing Major Mobility Disability

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Fish Oil Active n = 109	Fish Oil Placebo n = 71	Losartan Active n = 26	Losartan Placebo n = 17	Fish Oil Active + Losartan Active n = 26	Fish Oil Active + Losartan Placebo n = 13	Fish Oil Placebo + Losartan Active n = 13	Fish Oil Placebo + Losartan Placebo n = 14
Value	20	5	4	15	4	3	7	3

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fish Oil Active	30 of 109 (27.5%)	73 of 109 (67%)	0 of 109
Fish Oil Placebo	17 of 71 (23.9%)	46 of 71 (64.8%)	2 of 71
Losartan Active	3 of 26 (11.5%)	22 of 26 (84.6%)	1 of 26
Losartan Placebo	4 of 17 (23.5%)	16 of 17 (94.1%)	0 of 17
Fish Oil Active + Losartan Active	8 of 26 (30.8%)	20 of 26 (76.9%)	0 of 26
Fish Oil Active + Losartan Placebo	3 of 13 (23.1%)	12 of 13 (92.3%)	0 of 13
Fish Oil Placebo + Losartan Active	2 of 13 (15.4%)	10 of 13 (76.9%)	0 of 13
Fish Oil Placebo + Losartan Placebo	5 of 14 (35.7%)	11 of 14 (78.6%)	0 of 14

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28734043Manini TM, Anton SD, Beavers DP, Cauley JA, Espeland MA, Fielding RA, Kritchevsky SB, Leeuwenburgh C, Lewis KH, Liu C, McDermott MM, Miller ME, Tracy RP, Walston JD, Radziszewska B, Lu J, Stowe C, Wu S, Newman AB, Ambrosius WT, Pahor M; ENRGISE Pilot study investigators. ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design. J Am Geriatr Soc. 2017 Sep;65(9):1961-1968. doi: 10.1111/jgs.14965. Epub 2017 Jul 22.
Derived from this study: PubMed 30541065Pahor M, Anton SD, Beavers DP, Cauley JA, Fielding RA, Kritchevsky SB, Leeuwenburgh C, Lewis KH, Liu CK, Lovato LC, Lu J, Manini TM, McDermott MM, Miller ME, Newman AB, Radziszewska B, Stowe CL, Tracy RP, Walkup MP, Wu SS, Ambrosius WT. Effect of Losartan and Fish Oil on Plasma IL-6 and Mobility in Older Persons. The ENRGISE Pilot Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1612-1619. doi: 10.1093/gerona/gly277.
Individual participant dataSharing planned: Yes. The investigator will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for ENRGISE study approved research purposes and not to identify any individual human participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

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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.

Marco Pahor, MD principal investigator

University of Florida

Walter Ambrosius, PhD principal investigator

Wake Forest University

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega-3 fish oil and Losartan in people with Inflammation, run by University of Florida at 5 sites 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 6 inclusion and 42 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes in the Interleukin-6 Level Between Groups (time frame: Changes from baseline to month 12). The study lists 2 primary outcomes in all. 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 NCT02676466, 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 7 May 2024.