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Enhancing Adaptations to Exercise

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
n3-PUFA
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Exercise, muscle function

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Men and women between the ages of 20-35 years
  • Men and women between the ages of 65-85 years

Exclusion criteria:

  • Regular use of omega-3 nutritional supplements
  • Diabetes or fasting plasma glucose > or equal to 126 mg/dL
  • Anemia (female subjects hemoglobin of <11 g/dl and male subjects hemoglobin <12 g/dl)
  • Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
  • Renal failure (serum creatinine > 1.5mg/dl)
  • Chronic active liver disease (AST>144 IU/L or ALT>165 IU/L)
  • Oral warfarin group medications or history of blood clotting disorders.
  • international normalized ratio (INR) >2.01.5
  • Smoking
  • Pregnancy or breastfeeding
  • Alcohol consumption greater than 2 glasses/day or other substance abuse
  • Untreated or uncontrolled hypothyroidism
  • Debilitating chronic disease (at the discretion of the investigators)
  • Fish or shellfish allergy

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

n3-PUFA

Placebo

Arm Description

Participants will be instructed to swallow 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. The DHA/EPA soft gels will each contain ~465mg of EPA and ~375mg of DHA for a total daily dosage of 3.4g/day. The duration of the intervention will be 6 months.

Patients in this group will be supplemented with placebo capsules containing soybean oil. Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. The duration of the intervention will be 6 months.

Outcomes

Primary Outcome Measures

The mRNA expression of anabolic and metabolic signaling genes
Messenger ribonucleic acids (mRNAs) transfer the information from DNA to the cell machinery that makes proteins.
The expression and activation (phosphorylation) of signaling proteins
Phosphorylation is a common mechanism for the regulation of receptor function
The whole-body protein turnover
Protein turnover refers to the continual renewal or replacement of protein
Mitochondrial physiology in skeletal muscle
Mitochondrial physiology will be evaluated from the rates of respiration and reactive oxygen species production in mitochondria in skeletal muscle biopsy material.

Secondary Outcome Measures

Change in C-Reactive Protein (CRP)
C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.Units: mg/L
Change in Interleukin-6 (IL-6)
Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).Units: ng/ml
Change in Tumor Necrosis Factor-Alpha (TNF)
Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.Units: pg/ml

Full Information

First Posted
November 13, 2017
Last Updated
November 7, 2022
Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT03350906
Brief Title
Enhancing Adaptations to Exercise
Official Title
Enhancing Adaptations to Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA), National Center for Research Resources (NCRR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Researchers are trying to understand how chronic inflammation affects muscle function and responses to exercise.They are also trying to determine if suppressing chronic inflammation using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise responsiveness in older adults.
Detailed Description
Participants will be divided into two groups. Men and women between the ages of 20-35 years and 65-85 years. Participants in the older age group will be randomly assigned to receive groups (n3-PUFA or placebo (soybean oil)) in a double-blind manner. Before and after the intervention, all participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test, mixed meal test). During the intervention phase of the study, participants will be instructed to swallow 2 softgels twice per day with meals (morning and evening) for a total of 4 softgels per day. Every 4 weeks, participants will report to the Clinical Research and Trials Unit (CRTU) to pick up a new prescription and return any remaining capsules from the previous prescription. On the day they pick up prescription refills, participants will report to the CRTU for a fasting blood sample. The duration of the intervention will be 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Exercise, muscle function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
n3-PUFA
Arm Type
Experimental
Arm Description
Participants will be instructed to swallow 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. The DHA/EPA soft gels will each contain ~465mg of EPA and ~375mg of DHA for a total daily dosage of 3.4g/day. The duration of the intervention will be 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in this group will be supplemented with placebo capsules containing soybean oil. Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. The duration of the intervention will be 6 months.
Intervention Type
Drug
Intervention Name(s)
n3-PUFA
Intervention Description
participants will be instructed to swallow 2 softgels twice per day with meals (morning and evening) for a total of 4 softgels per day. The DHA/EPA softgels will each contain ~465mg of EPA and ~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule will contain SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (~381 mg) and poloxamer 237, NF (~8.8 mg).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients in this group will be supplemented with placebo capsules containing soybean oil. Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. The duration of the intervention will be 6 months.
Primary Outcome Measure Information:
Title
The mRNA expression of anabolic and metabolic signaling genes
Description
Messenger ribonucleic acids (mRNAs) transfer the information from DNA to the cell machinery that makes proteins.
Time Frame
changes between baseline and 26 weeks
Title
The expression and activation (phosphorylation) of signaling proteins
Description
Phosphorylation is a common mechanism for the regulation of receptor function
Time Frame
changes between baseline and 26 weeks
Title
The whole-body protein turnover
Description
Protein turnover refers to the continual renewal or replacement of protein
Time Frame
changes between baseline and 26 weeks
Title
Mitochondrial physiology in skeletal muscle
Description
Mitochondrial physiology will be evaluated from the rates of respiration and reactive oxygen species production in mitochondria in skeletal muscle biopsy material.
Time Frame
changes between baseline and 26 weeks
Secondary Outcome Measure Information:
Title
Change in C-Reactive Protein (CRP)
Description
C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.Units: mg/L
Time Frame
changes between baseline and 26 weeks
Title
Change in Interleukin-6 (IL-6)
Description
Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).Units: ng/ml
Time Frame
changes between baseline and 26 weeks
Title
Change in Tumor Necrosis Factor-Alpha (TNF)
Description
Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.Units: pg/ml
Time Frame
changes between baseline and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Men and women between the ages of 20-35 years Men and women between the ages of 65-85 years Exclusion criteria: Regular use of omega-3 nutritional supplements Diabetes or fasting plasma glucose > or equal to 126 mg/dL Anemia (female subjects hemoglobin of <11 g/dl and male subjects hemoglobin <12 g/dl) Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment) Renal failure (serum creatinine > 1.5mg/dl) Chronic active liver disease (AST>144 IU/L or ALT>165 IU/L) Oral warfarin group medications or history of blood clotting disorders. international normalized ratio (INR) >2.01.5 Smoking Pregnancy or breastfeeding Alcohol consumption greater than 2 glasses/day or other substance abuse Untreated or uncontrolled hypothyroidism Debilitating chronic disease (at the discretion of the investigators) Fish or shellfish allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian R Lanza, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35389487
Citation
Moosavi D, Vuckovic I, Kunz HE, Lanza IR. A Randomized Trial of omega-3 Fatty Acid Supplementation and Circulating Lipoprotein Subclasses in Healthy Older Adults. J Nutr. 2022 Jul 6;152(7):1675-1689. doi: 10.1093/jn/nxac084.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Enhancing Adaptations to Exercise

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