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NutraSpace Co-Sponsors Research at the University of Miami Miller School of Medicine

NutraSpace has co-sponsored research on the relation between nutrition, fitness, integrative medicine and health at the University of Miami Miller School of Medicine’s Center for Complementary and Integrative Medicine. Professor John Lewis of the University of Miami Miller School of Medicine has provided the list below of the Center’s active research projects.

I. Current Active Studies:

Glyconutrient supplement on Alzheimer’s disease 

Gingko Biloba, grape seed and green tea extract, and other micronutrients on cognition in healthy, elderly adults
Methylated vitamin B complex on depression
Aerobic and strengthening exercise training on metabolic syndrome in HIV
Magnesium sulfate on depression
Pulsed electro-magnetic frequency on chronic knee pain 

1. Glyconutrient supplement on Alzheimer’s disease

The purpose of this study is to investigate the health outcomes of a 12-month course of glyconutrients (monosaccharides) among Alzheimer’s patients. Subjects are assessed at baseline and 3-, 6-, 9-, and 12-month follow-up with a battery of measures for cognitive functioning, disease severity, activities of daily living, and quality of life. Physiological parameters are tested at baseline and 12 months: monocytes/lymphocytes (CD4, CD8, CD45, CD14, CD34, CD90, and CD95), cytokines (IL-2, IL-4, IL-6, IL-8, IL-10, IL-1alpha, IL-1beta, IFN-gamma, TNF-alpha, MCP-1, VEGF and EGF), and micro array analysis of RNA of the stem cells to identify significantly expressed genes before and after supplementing with a regimen of glyconutrients.

2. Gingko biloba, grape seed and green tea extract, and other micronutrients on cognition in healthy, elderly adults

The study is a 6-month, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a regimen of whole-food nutritional supplements on cognition in 90 persons (60+ years of age) with no history of significant cognitive deficits. Participants will be assessed at baseline and 3 and 6 months, and the study will consist of three treatment arms, including: (a) Ginkgo Synergy and Choline; (b) OPC Synergy and Catalyn; and (c) placebo. Additionally, the study will examine inflammation (12-panel cytokines), functional status, and quality of life.

3. Methylated vitamin B complex on depression

The study is a 60-day, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of methylated vitamin B complex (Max Stress B™) for improving depressive and anxiety symptoms according to the Beck Depression and Anxiety Inventories, respectively, in 60 patients (18+ years of age) diagnosed with major depression or other forms of depressive disorders and an elevated level of homocysteine (> 10 µmol/L) at baseline. Secondary outcomes include body composition, blood pressure and pulse, level of physical activity, dietary intake, and quality of life. Participants will be assessed at baseline and 30 and 60 days. The study will consist of two treatment arms: (a) vitamin B complex and (b) placebo.

4. Aerobic and strengthening exercise training on metabolic syndrome in HIV

The purpose of the study is to evaluate the efficacy of a 12-week, combined exercise (cardiovascular and strength) training for improving immune functioning (CD4 T cells and viral load) and metabolic syndrome variables (total, LDL, and HDL cholesterol, triglycerides, blood pressure, waist and hip circumference, and body mass index) in HIV+ patients (18+ years of age) on stable HAART.

5. Magnesium sulfate on depression

This is a randomized, double-blind, two-phase, cross-over study in 20 male and female volunteers with mild to moderate depression. In Phase 1, each subject will be randomized in a double-blind fashion to receive either IV infusion of Magnesium Sulfate or 5% Dextrose followed by washout for 5 days then crossover to receive either 5% Dextrose or IV infusion of Magnesium Sulfate followed by Phase 2 in which each subject will receive in an open-label fashion oral Magnesium Citrate daily for 3 months total duration. Assessments will occur at baseline, Day 1, Day 2, Day 7, Day 8, Day 14, Day 45, Day 75 and Day 105. There will be a telephone interview/follow-up on a weekly basis except for the week of assessment following the oral dosing on Day 14.

6. Pulsed electro-magnetic frequency on chronic knee pain

The purpose of the study is to determine and compare the clinical effectiveness of pulsed electro-magnetic frequency (PEMF) devices of different power levels in providing a reduction in pain and inflammation as well as increased range of motion and a return to a normal health and activity level. PEMF devices are non-heat producing and will be tested in the treatment of individuals with chronic knee pain using a combination of survey, physical activity, biomechanical, neuromuscular, and hematological assessments of inflammation, pain, and range of motion. Forty-eight subjects will be recruited. Subjects will include males and post-menopausal females ages 45-65 years. The subject population to be selected and studied will include individuals with a medical history of diagnosed chronic knee pain.

II. We have the following upcoming studies:

Basidiomycete mushroom nutritional supplement on safety, fatigue, and inflammation in breast cancer patients undergoing taxane-based chemotherapy
Vitamin D supplementation in healthy, elderly individuals
Laser therapy treatment of peripheral neuropathic pain in individuals with type 2 diabetes

1. Basidiomycete mushroom nutritional supplement on safety, fatigue, and inflammation in breast cancer patients undergoing taxane-based chemotherapy

The purpose of this study is to determine the safety and tolerability of basidiomycete mushroom in female breast cancer patients undergoing adjuvant taxane-based chemotherapy. We will determine if AHCC is safe and tolerable in patients receiving chemotherapy and if it can impact quality of life and inflammation by ameliorating common side effects such as fatigue, nausea, vomiting, or neuropathic pain. Subjects will be assessed at baseline (visit 1, week 0), visit 2 (week 6), and visit 3 (week 12) on NCI common adverse events, treatment adherence, CBC, INR, liver function tests, the EORTC quality of life questionnaire core cancer module (QLQ-C30) and Breast Module (BR-23 Breast), NK cell activity, and a cytokine 4-plex panel (TNF-a, IL-1β, IL-6, and IL-10).

2. Vitamin D supplementation in healthy, elderly individuals

The purpose of this study is to the effect of a vitamin D emulsion on serum vitamin D levels in healthy, elderly people 60 years of age and older. We will determine if this formula is superior to placebo on serum vitamin D and secondary outcome measures, such as body composition and quality of life. Subjects will be assessed at baseline, visit 2 (week 4), and visit 3 (week 8) on serum vitamin D, body composition (body fat, BMI, waist to hip ratio), and the SF-36 quality of life questionnaire.

3. Laser Therapy Treatment of Peripheral Neuropathic Pain in Individuals with Type 2 Diabetes

This study is a randomized, double-blinded factorial trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with type 2 diabetes. Participants will be assessed at baseline, post-intervention, and 3-months follow-up, and the study will consist of two treatment arms, including: (a) once-per-week laser treatment for 12 weeks or (b) once-per-week sham (or placebo) treatment for 12 weeks. Additionally, the study will examine inflammatory markers, functional status, and quality of life.

III. We have the following studies that have concluded enrollment and are in the analysis phase:

Food sensitivity testing/food elimination on disease-specific symptoms in weight loss, diabetes, headaches, and GI complaints 

A polysaccharide (rice bran and Shiitake mushroom) on immunological functioning
The effect of Tai Chi on smoking cessation

1. Food sensitivity testing/food elimination on disease-specific symptoms in weight loss, diabetes, headaches, and GI complaints

The purpose of this study is to investigate the ability of a novel food sensitivity test, which identifies foods as reactive, to have a positive effect on disease-specific symptoms in four classes of patients: persons with type II diabetes, overweight/obese who are interested in losing weight, persons with headaches or migraines, and persons with digestive disorders. Each participant receives a lab report indicating their reactive foods and is given a plan for eliminating those foods from the diet for 90 days. Participants are assessed for disease-specific symptoms, blood pressure, heart rate, physical activity levels, functional health and well-being, body mass index, body fat, and waist and hip circumference.

2. A polysaccharide (rice bran and Shiitake mushroom) on immunological functioning

The purpose of this study is to investigate the outcomes of a 60-day trial of rice bran arabinoxylan partially hydrolyzed by an enzyme complex from Shiitake mushroom among adults. Specifically, subjects will participate in a two-group, randomized intervention. One group will take 1 gram/day and the other group will take 3 gram/day to compare differences in outcomes between the two groups. The primary outcomes for this study will be Natural Killer cell activity, cytokines, total bilirubin, creatinine, and liver function tests. Outcomes will be compared between groups at baseline, 48 hours, 1 week, and 30 and 60 days.

3. The effect of Tai Chi on smoking cessation

The purpose of this study is to investigate the smoking outcome of a Tai Chi for Health intervention among smokers who are interested in stopping. This 12-week group intervention focuses on improving: muscular strength and flexibility, heart and lung capacity, posture, balance, and the integration of the mind and body. Specifically, subjects attend 3 sessions per week for 3 months. The primary outcome for this study is smoking cessation, and we also measure blood pressure, heart rate, physical activity levels, functional health and well-being, body mass index, body fat, and waist and hip circumference.

IV. We are actively pursuing funding for the following proposals:

The effect of hyperbaric oxygen and glyconutrients on Alzheimer’s disease 

Enhancing the tumoricidal activity of natural killer cells with a polysaccharide (rice bran and Shiitake mushroom) nutritional supplement
The effect of exercise training on quality of life and inflammation in breast cancer
The effect of enhanced nutrition on metabolic syndrome in HIV

1. The effect of hyperbaric oxygen and glyconutrients on Alzheimer’s disease

The purpose of this study is to evaluate the effect of a hyperbaric oxygen and nutritional supplement intervention on the health outcomes of Alzheimer’s patients. Specifically, subjects will be randomized to participate in either: (1) HBO, (2) glyconutrients, or (3) HBO plus glyconutrients. The goals of this study are to test the hypothesis that the interventions will demonstrate improvements in outcomes, such as disease severity, quality of life, cognitive functioning, memory, and physiological parameters, i.e., monocytes (CD45, CD3, CD4, CD8, CD16+CD56+, CD19, CD14, CD34, CD90, and CD95), cytokines (IL-2, IL-4, IL-6, IL-8, IL-10, IL-1α, IL-1β, IFN-γ, TNF-α, MCP-1, VEGF, and EGF), and mRNA of the monocytes to identify significantly expressed genes before and after supplementing with a regimen of glyconutrients is a novel approach to linking clinical outcomes with basic scientific analyses in AD. The results of the study are intended to address the multi-faceted problems of AD victims, who would otherwise participate in standard conventional treatments that have limited efficacy.

2. Enhancing the tumoricidal activity of natural killer cells with a polysaccharide (rice bran and Shiitake mushroom) nutritional supplement

The purpose of this study is to investigate the physiological significance of a polysaccharide in modulating the tumoricidal activity of natural killer cells. Subjects will undergo treatment with the nutritional supplement of 3 quantities and 3 durations of exposure to determine its impact on modulating tumoricidal activity of NK cells for cancer prevention and the underlying mechanism(s) accounting for this response. We will assess the effect of the polysaccharide on: (1) the tumoricidal cell receptors and cancer cell specific ligands; (2) the release of tumoricidal cytokines such as IFN-γ; and (3) the release of lytic granules, such as granulysin, perforin, and serine proteases (granzymes).

3. The effect of exercise training on quality of life and inflammation in breast cancer

This study proposes to address the impact of an aerobic and strengthening exercise training intervention on quality of life (sickness-related behaviors-mood, fatigue, and sleep), inflammation, neurocognitive regulation, and fitness and body composition levels in breast cancer survivors. We plan to enroll patients who are in their final week (± 1 week) of adjuvant treatment. Participants will be randomized to either the immediate exercise intervention for 12 weeks of training and 12 weeks of follow-up with no training (n=20) or a wait-list control with 12 weeks of no initial training followed by 12 weeks of exercise training (n=20). We will examine the impact of an aerobic and strengthening exercise training program (3 times per week for 12 weeks) on quality of life behaviors, pro- and anti-inflammatory cytokines and C-reactive protein, diurnal cortisol, cardiovascular and strength fitness levels, and body fat percent and body mass index. The primary goal of this study is to determine the efficacy of exercise training on improving sickness-related behaviors (mood, fatigue, and sleep), immune system and neuroendocrine functioning, fitness levels, and body composition among breast cancer survivors, which is currently unaddressed in the literature. The results of this study can be utilized to plan additional research to address questions related to intensity, duration, and mode of exercise in the breast cancer population.

4. The Effect of Enhanced Nutrition on Metabolic Syndrome in HIV

This study proposes to address the impact of a broad-spectrum, whole-food nutritional supplement on metabolic syndrome variables (fasting plasma glucose, waist circumference, high-density lipoprotein cholesterol, triglycerides, and blood pressure) and secondarily on additional atherogenic variables (total cholesterol, low-density lipoprotein cholesterol, insulin resistance, hip circumference, C-reactive protein, body mass index, and percent body fat) among HIV+ adult (18+ years of age and over) patients dually-diagnosed with metabolic syndrome on stable antiretroviral therapy (ART). Participants will be randomized to either the immediate intervention for 12 weeks of taking the nutritional supplement and 12 weeks of follow-up with no supplementation or a wait-list control with 12 weeks of no supplementation followed by 12 weeks of taking the nutritional supplement. Each group will be evaluated at baseline and 12 and 24 weeks on all of the outcome measures. The primary goal of this pilot study is to demonstrate the efficacy of enhanced nutritional status with a broad-spectrum, whole-food supplement on metabolic syndrome and other atherogenic variables, which is currently an unaddressed question in the HIV literature. 

 

About

Nutrition, Exercise, and Integrative Medicine Interventions in Chronic Disease at the University of Miami

 

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