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Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults
NA trial testing TDAP in Sarcopenia in 59 participants. Completed in 30 September 2019.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 59 |
| Start date | 23 July 2014 |
| Primary completion | 31 December 2018 |
| Estimated completion | 30 September 2019 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
Adults 60 to 80, any sex, with Sarcopenia or Aging. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 63.1 | ± 39.7 |
| Placebo | 63.2 | ± 40.7 |
The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 159.2 | ± 130.7 |
| Placebo | 216.7 | ± 240.1 |
Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 0.34 | ± 1.52 |
| Placebo | -3.96 | ± 10.05 |
The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 16.01 | ± 49.36 |
| Placebo | -8.54 | ± 25.70 |
The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 195.4 | ± 54.4 |
| Placebo | 182.9 | ± 45.7 |
The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 5.6 | ± 2.4 |
| Placebo | 4.1 | ± 2.6 |
The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 8.6 | ± 3.7 |
| Placebo | 8.2 | ± 5.1 |
The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 1.1 | ± 1.2 |
| Placebo | 1.1 | ± 1.4 |
The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 2.1 | ± 1.6 |
| Placebo | 1.7 | ± 1.5 |
The number of muscle macrophages per myofiber will be counted for resting muscle collected before and after two weeks of treatment with supplement or placebo.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 6.89 | ± 21.99 |
| Placebo | 42.42 | ± 51.74 |
The change in size of the thigh muscle group after exercise training will be measured as the difference in cross-sectional area based on CT scan before and after completion of the exercise training program.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 155.8 | ± 24.1 |
| Placebo | 146.4 | ± 22.6 |
The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.
| Group | Value | 95% CI |
|---|---|---|
| Nutritional Supplement | 175.5 | ± 50.0 |
| Placebo | 162.9 | ± 34.5 |
Time frame: Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nutritional Supplement | Placebo |
|---|---|---|---|
| lost name and address | Product Issues | — | — |
| Cardiovascular Event | Cardiac disorders | — | — |
| gallstones | Hepatobiliary disorders | — | — |
| cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| colon polyps | Gastrointestinal disorders | — | — |
| knee surgery | Musculoskeletal and connective tissue disorders | — | — |
| unknown surgery | General disorders | — | — |
| SAE | Cardiac disorders | — | — |
| Reaction | System | Nutritional Supplement | Placebo |
|---|---|---|---|
| musculoskeletal soreness, strain, or pain | Musculoskeletal and connective tissue disorders | — | — |
| skin irritation, rash, or numbness | Skin and subcutaneous tissue disorders | — | — |
| cold, flu, or infection | General disorders | — | — |
| biopsy pain or bruise | General disorders | — | — |
| bodily wound | General disorders | — | — |
| gastrointestinal distress | Gastrointestinal disorders | — | — |
Most-reported serious reactions: lost name and address, Cardiovascular Event, gallstones, cancer, colon polyps, knee surgery, unknown surgery, SAE.
Data from ClinicalTrials.gov NCT02261961 adverse events section.
The loss of muscle mass and strength due to aging leads to serious health problems for older adults. Muscle health can be improved by exercise training, but some people improve their strength substantially, whereas others improve little. The reason for this variation is unknown. This study will investigate whether function of the immune system influences how well people respond to exercise. Older Veterans who participate will have their muscle size, strength, and function measured periodically for almost a year. Participants will drink a nutritional supplement or placebo daily and complete a 36 session strength training program. Participants will be vaccinated for tetanus and donate small amounts of blood and muscle tissue during the study so that immune function can be compared to muscle outcomes during training and during a long-term follow-up. The study results should increase the investigators' understanding of the negative effects of aging on muscle and will possibly lead to better strategies for muscle maintenance and rehabilitation for older adults.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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