3 g/d soy oil: corn oil (50:50 ratio) + placebo powder

Chronic Obstructive Pulmonary Disease

For Fish oil and Placebo oil, treatment will be provided in capsules.Each group will receive dose distributed to 3 capsules per day. Participants will be instructed to take all capsules with morning meal. . For HMB and a placebo powder, product will be delivered as powder taken with water or non-carbonated beverage (like juice). Product will be provided in 2 sachets/day. One sachet should be consumed with breakfast and the other prior to bedtime (approx. 10pm).

Capsule + Powder supplementation

labeled amino acids L-Phenylalanine (ring-13C6), L-Tyrosine (ring-D4), and tau-Methylhistidine will be infused as a single injection. Subsequently, the catheter will be used for arterialized venous blood samples (3 ml) drawn multiple through the day

stable tracer infusion

Texas A&M University-CTRAL

Fish Oil and HMB Supplementation in COPD

Effects of Low Dose of Fish Oil (EPA+DHA) vs. Combined EPA+DHA and HMB Supplementation on Protein Metabolism, Muscle Mass and Functional Capacity in Moderate to Severe COPD

whole body protein synthesis and myofibrillar protein breakdown measured by labeled amino acids on each study day via blood drawn at time 4, 10, 15, 20, 30, 40, 60, 120, 180, 240 minutes of infusion

Body composition as measured by Dual-Energy X-ray Absorptiometry

Micro-respiratory pressure meter to measure maximum inspiratory and expiratory pressure

walk a predetermined loop of 69.77 meters (228.89 feet) at self-selected pace for six minutes

blood sample will be taken to measure c-reactive protein levels

Oxygen consumption and carbon dioxide production will be calculated from the airflow in a transparent plastic (Plexiglas) hood to determine concentration differences between inhaled and exhaled air

Marielle PKJ Engelen, PhD

Associate Professor

Texas A&M University

Control diet containing average US polyunsaturated fatty acid (PUFA) content with low omega-3 and high omega-6 content

Post-Traumatic Headache Chronic Without Intractable Headache

The intervention will be administered through food products rather than dietary supplements

Diet/nutrition intervention

Medline Plus related topic: Traumatic Brain Injury

Medline Plus related topic: Post-traumatic headache

Walter Reed National Military Medical Center

Womack Army Medical Center (WAMC)

Fort Belvoir Community Hospital

Nutrition for Post-Traumatic Headache

Targeted Alteration in Omega-3 and Omega-6 Fatty Acids for Post-traumatic Headache (Nutrition for PTH)

Up to 300 participants complete the Headache Impact Test (HIT-6)—a headache-specific quality of life measure 6 times while enrolled in the study. The primary outcome measure is the change in the HIT-6 scores at baseline and at the end of the diet intervention.

All study participants will have blood drawn 3 times during the 16-week study for analysis of circulating fatty acids and their bioactive metabolites. The following fatty acids will be measured in each blood sample (ng or pg per mL): 17-hydroxy-DHA (docosahexaenoic acid), 18-Hydroxy-EPA (eicosapentaenoic acid), 9-HODE (hydroxyl-octadecadienoic acid), 13-ODE (octadecadienoic acid), 5-HETE (hydroxyl-eicosatetraenoic acid), 8-HETE, 9-HETE, 11-HETE. Changes in 17-hydroxy-DHA and related fatty acids levels between blood draws at baseline and at the end of the 12-week diet intervention will be compared with changes in headache frequency and severity at the same time points.

Up to 300 participants complete a headache diary daily while enrolled in the 16-week study. Participants record the total number of headache hours per day. The outcome measure is the change in the mean daily headache hours at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in non-headache pain. A survey of pain, the Total Body Pain Scale, will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a reduction in non-headache pain as measured by the survey at baseline and at the end of the diet intervention.

Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in: Use of acute pain medications. Participants will daily record all pain medications used in that 24-hour period. The outcome measure is the change in the acute pain medications sued at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in sleep quality. A sleep quality survey, the PSQI, will be administered at baseline at and the end of the 12-week diet intervention. The outcome measure is the change in the PSQI score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

The PROMIS-29, a survey of psychological distress (depression/anxiety), will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a reduction in depression and/or anxiety as measured by the PROMIS-29 at baseline and at the end of the diet intervention.

Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in symptoms of post-traumatic stress disorder (PTSD). The PCL-C, a survey of post-traumatic stress symptoms, will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is the reduction in the PCL-C score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in post-concussive symptoms. The Neurobehavioral Symptom Inventory (NSI) and the Glasgow Outcome Score-Extended (GOS-E) will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a change in the NSI and GOS-E score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

Study data to be uploaded into Federation Interagency Traumatic Brain Injury Repository (FITBIR) and made accessible after study is completed

Kimbra Kenney

Associate Professor, Neurology

Uniformed Services University of the Health Sciences

Womack Army Medical Center

University of North Carolina, Chapel Hill

National Institutes of Health (NIH)

"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight)

physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)
+ individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight)

HMB supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)
+ individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

LC supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)
+ individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

EPA supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)
+ individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

Cancer

Cancer Cachexia

Weight Loss

Muscle Loss

Muscle Weakness

β-hydroxy-β-methylbutyrate (HMB)

L-carnitine (LC)

Eicosapentaenoic acid (EPA)

WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial

Whole-Body Electromyostimulation (WB-EMS)

Hector-Center for Nutrition, Exercise and Sports

Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment

Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

Isometric hand grip strength assessed by hand Dynamometer (in kg)

Six-minute-walk test (walking distance in m)

30 second sit-to-stand test (number of sit-to-stand cycles)

Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin

University of Erlangen-Nürnberg Medical School

Low Dose (FFM <49kg): 30.00g milk protein + 12.75g maltodextrin and 6g fish oil
High dose (FFM >49kg): 40.00g milk protein + 17.00g maltodextrin and 8g fish oil

Low Dose (FFM <49kg): 30.00g milk protein + 12.75g maltodextrin and 6g olive oil
High dose (FFM >49kg): 40.00g milk protein + 17.00g maltodextrin and 8g olive oil

Low Dose (FFM <49kg): 12.75g maltodextrin and 6g olive oil
High dose (FFM >49kg): 17.00g maltodextrin and 8g olive oil

Cancer Patients Receiving Chemotherapy or Chemoradiotherapy

Daily intake for 10 weeks (+/- 2 weeks)

Nutrition Intervention During Chemotherapy

Effects of Chemotherapy and Nutritional Intervention on Gut Function and Metabolism in Cancer

The acute change in whole-body protein synthesis rate before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Plasma enrichment of citrulline is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Recovery of 3-O-Methyl-D-glucose in the urine is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Recovery of rhamnose/lactulose in urine is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls on test day 1. The cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism. The cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Enrichment in palmitic acid and tripalmitin fatty acids in plasma in response to a meal is measured on the first test day in for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina in response to a meal is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Hydroxyproline enrichment in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Tryptophan enrichment in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

The acute change in insulin levels before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Fat free mass is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

The acute change 3-methylhistidine enrichment in plasma before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Glycine enrichment in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Enrichment of taurine in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.

Functional status will be assessed by the Karnofsky Performance Score, a widely used method to assess the functional status of a cancer patient. It describes a patient's functional status as a comprehensive 11-point scale ranging from 0% to 100%.

combination of dietary sodium restriction with supplementation of omega-3 capsules and lycopene containing juices or foods

Limited nutritional counseling, juice without lycopene, rice oil capsules

Heart Failure

Teaching and skill building to reduce dietary sodium

Sodium reduction

omega-3 fatty acid supplements and juices containing lycopene

omega 3 and lycopene supplements

rice bran oil capsules

Provided a summary of the 3 day dietary recalls at baseline, 3 months, and 6 months

Generic dietary feedback from

University of Kentucky, College of Nursing

Norton Health Care

Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure

Nutrition Intervention to Reduce Symptoms in Patients With Advanced Heart Failure

Combined endpoint of cardiac-related hospitalization and all cause mortality

combined score of symptom severity, frequency, and distress for common symptoms of heart failure

the ratio of EPA plus DHA as a percentage of total fatty acids in the cell membrane of erythrocytes

serum levels of malondialdehyde and 8-iso-PGF2a isoprostane will serve as markers of increased lipid peroxidation due to oxygen free radical production exceeding antioxidant capacity

Serum levels of tumor necrosis factor-alpha (TNFα), soluble TNF receptors: sTNFR1 and sTNFR2 will be measured as markers of proinflammatory cytokine activity; interleukin-10 (IL-10) will be measured as a marker of anti-inflammatory cytokine activity

Plasma lycopene will be measured as a marker intervention effectiveness

Three 24-hour diet recall interviews at each timepoint will be used estimate sodium intake and to identify high sodium foods and eating patterns for the sodium reduction component of the intervention.

eicosapentaenoic acid/fatigue

Fish Oil and HMB Supplementation in COPD

Nutrition for Post-Traumatic Headache

Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Nutrition Intervention During Chemotherapy

Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure

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