The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. Participants will have access to online material through our Imagine Healthy Online Portal and will be given take-home activities, referred to as IMAGINE actions. These homework assignments will focus on goal setting for nutrition, physical activity, and stress reduction. The nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components.

The standard of care arm will receive general health information (e.g., general guidelines of healthy eating and physical activity, stress management, cancer screening, etc.). This information will be provided through email, which will include a weekly newsletter, healthy recipes that are not focused on reducing the DII scores, links to online content, and health-related event announcements in and around Columbia, SC.

Inflammation

Diet Modification

DII-Based Counseling System, including 12 weekly classes in reducing inflammation by adopting dietary patterns low in inflammation and also through physical activity and stress reduction. Participants will also have access to our Imagine Healthy Online Portal. Group-based behavior change programs provide a way for members to share successes and obtain and provide support to one another.

DII-Based Counseling System

The standard of care arm will receive general health information (e.g., general guidelines of healthy eating and physical activity, stress management, cancer screening, etc.). This information will be provided through email, which will include a weekly newsletter, healthy recipes that are not focused on reducing the DII scores, links to online content, and health-related event announcements in and around Columbia, SC. Any participants in the standard of care arm who does not use email regularly may request for items to be mailed to their mailing address.

general health education control

Connecting Health Innovations

Watermelon Focused Dietary Inflammatory Index Intervention

A Watermelon Focused Dietary Inflammatory Index Counseling System to Reduce Systemic Inflammation

Investigators will examine if there is decrease in the levels of CRP from baseline to 3 months.

Investigators will examine if there is decrease in the levels of HbA1C from baseline to 3 months.

If investigators decide to share they plan to share the dietary and outcome data for analyses and publishing papers

Connecting Health Innovation

National Watermelon Promotion Board

The two arms of this intervention study will be the DII-Based Counseling System, including access to our Imagine Healthy Online Portal, and a general health education control. Group-based behavior change programs provide a way for members to share successes and obtain and provide support to one another. Both arms will be composed of 1 wave of 15 individuals. Participants will be required to invite a partner of their choosing to join them in the intervention activities to improve social support for behavioral change. Investigators have experience conducting studies where participants invite partners to participate.

Supervised Facility-Based Exercise Intervention Arm The participants randomized to the exercise group will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. This intervention will use heart rate and rating of perceived exertion (RPE) to define moderate intensity. Participants will exercise for the prescribed duration at a heart rate in the range of 45-65% of their maximal oxygen consumption (VO2 max), as determined during baseline testing, and with an RPE in the range of 11-14 on the 20-point scale. The exercise will primarily utilize treadmills and exercise bikes.

After baseline testing, the control group will be asked to maintain their current daily activities and exercise habits for the duration of the study (6 months). The control group will have measurements at the same time periods as the participants in the intervention arm through the completion of the study. Participants will be seen for follow-up at 3 and 6 months (study completion). The participants in the control group will receive the same incentives as those in the intervention arms (gift cards). Since the women in the control group are obese, with components of metabolic syndrome, and at relatively high risk for breast cancer, we are providing healthy lifestyle information to the group, via text messages.

Home-Based Exercise Intervention Group The participants randomized to this intervention arm will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months, the same as the supervised intervention group. Their exercise goal will be to achieve a total of 10,000 steps per day, as measured by pedometers. Participants will be required to have a cell phone with text messaging capabilities.

Metabolic Syndrome

Obesity

Facility-based Exercise

Home-based Exercise

Georgetown Lombardi Office of Minority Health community site

An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer

An Exercise Randomized Controlled Trial Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer

Serum IL-6, TNF-alpha, High sensitivity CRP

Fasting glucose, seruminsulin, IGF-1, IGFBP-3

Greater improvements in metabolic syndrome and metabolic syndrome components

VO2Max using the Bruce treadmill protocol

Measured using DEXA scan: fat mass, lean mass

Georgetown University

Assess the Effects of a the 90-day Oral TS Study Regimen on PSA, IPSS, Haemoglobin and Haematocrit, and to Assess Adverse and Serious Adverse Events.

Andriol Testocaps

Camry Medical Centre

Frontier Medical Associates (Ubi) Pte Ltd

Everhealth Medical Centre

Frontier Medical Associates (Buangkok Cresent) Pte Ltd

Frontier Medical Associates (AMK) Pte Ltd

EJ Tan Clinic & Surgery

Everhealth Family Clinic & Surgery

Bukit Batok Medical Clinic

Princeton Family Clinic Pte Ltd

The Edinburgh Clinic

Frontier Medical Associates (Woodlands) Pte Ltd

Frontier Medical Associates (Yishun) Pte Ltd

The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)

The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes: OTEST

The primary aim is to assess the effect of oral Testosterone Supplementation on percent change in HbA1c in Type 2 Diabetes Mellitus Chinese males in Singapore over a 90-day study period.

The secondary aim is to assess the effects of site, eugonadism and hypogonadism, and the prognostic relevance of baseline levels of HbA1c, total testosterone, PSA, IPSS, haemoglobin and haematocrit on 90-day change and percent change from baseline in HbA1c under the study Testosterone Supplementation regimen.

Singapore Clinical Research Institute

Singapore General Hospital

Duke-NUS Graduate Medical School

AGE (1200 mg) and CoQ10 (120 mg)
This is a combination of aged garlic extract and co-enzyme Q10

Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)

Aged Garlic Extract and Coenzyme Q10

Placebo

Total

Sex: Female, Male

Region of Enrollment

progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.

Rate of Change in Total Coronary Calcium Scores by Computed Tomography

1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH

Overall Study

Dr Matthew Budoff

Coronary Atherosclerosis

Coronary Artery Calcification

Coronary Stenosis

Aged garlic extract and Coenzyme Q10

Contact Drs Budoff or Laidlaw for further information

skin neoplasms/triglyceride

Watermelon Focused Dietary Inflammatory Index Intervention

An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer

The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)

Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)

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