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Nutrition and Weight Management

Research

Our Research Team

Caroline M. Apovian, MD - Director, Nutrition and Weight Management Center

Nawfal Istfan, MD, PhD - Director, Nutrition Research Center

Dong Wook Kim, MD - Nutrition Investigator

Kenya Palmer, MS, FNP - Nutrition Investigator

Lorrie Young, RD, MS, LDN, CNSC - Nutrition Investigator

Samar Hafida, MD - Nutrition Fellow

Ashley McCarthy ([email protected]) - Clinical Research and Grants Manager

Rena Wiesen, RD, MPH ([email protected]) - Research Dietitian

Ida Pantoja-Feliciano, PhD ([email protected]) - Research Coordinator

James McCarthy ([email protected]) - Administrative Coordinator

Investigators: If you're interested in collaborating with Nutrition and Weight Management on a research study, please contact Ashley McCarthy at [email protected].

Industry-Sponsored Weight Loss Research Studies

Gelesis Loss of Weight (GLOW) Study (Currently Enrolling)

We are recruiting overweight and obese participants for a clinical research study investigating a product in capsule, Gelesis100. If you would like to participate in a clinical research study testing the effect of Gelesis100 and receive dietary counseling for weight loss, we would like to hear from you.

Gelesis100, administered in capsules, contains two commonly used food ingredients. The study is investigating if capsules containing a dosage of Gelesis100 can promote your weight loss. The capsules should be ingested daily before lunch and dinner.

We are looking for overweight and obese women and men, with or without type 2 diabetes. In order to participate, you should at least fulfill the following criteria:

  • Age: 22-65 years
  • BMI between 27 and 40 kg/m2
  • Generally healthy with the exception of overweight/obesity and type 2 diabetes

You cannot participate in the study, if you for example:

  • Have had obesity surgery
  • Have an eating disorder
  • Have a gastrointestinal disorder
  • Are pregnant or lactating or planning pregnancy within the next 8 months

If you would like to participate, the study staff and doctor will take you through a screening process in order to assess if you fulfill all criteria for participating in the study.

The study will last up to 31 weeks and consists of 14 visits including physical examinations and blood samplings conducted at our research center. The study product should be ingested twice daily for 24 weeks. During the study, several questionnaires should be completed either at the visits or at home. You will receive capsules containing either Gelesis100 or inactive ingredient (placebo). The product you will receive during the study is assigned to you randomly (by chance, like the flip of a coin). Both you and the clinical personnel involved in the study will be blinded to the product you receive during the entire study.

All assessments, dietary counseling, and study products are free.

If you are interested in participating and would like to obtain more information about the study, you are welcome to contact Ida Pantoja at 617-414-2935 or [email protected]

Nutrition Research Studies

Optimizing Protein with Testosterone in Men (OPTIMen) Study (Currently Enrolling)

The main purpose of the study is to evaluate whether a higher amount of daily protein in your diet will improve muscle mass, strength and physical function. The study will also evaluate whether adding weekly testosterone injections further improves a person's muscle mass, strength and physical function. There will be up to 31 study visits over 7 months. To participate, you must be a man 65 years or older. During the study, you will receive 3 meals per day and a powder supplement that must be taken 3 times per day. You will also either receive the study medication (testosterone) or placebo in a weekly in-person injection. Visits also include a few physical exams, exercise tests and blood tests. Financial compensation is provided.

Recruitment for this study has recently moved to the Section of Men's Health, Aging and Metabolism at Brigham and Women's Hospital. For more information, please contact 617-732-5500 or visit http://www.androtrials.org/studies/optimen/.

Insulin and Glucose Metabolism Study (Closed to Enrollment)

The purpose of this study is to understand how eating a low-fat diet may contribute to fat storage in adipose (fat) tissue and may lead to inflammation and changes in fat cell function that could lead to disease. During this study you will complete 3 in-person study visits:

  • Screening Visit: This 1-hour visit includes a short physical exam, medical history, blood draw (about 1 tablespoon), height and weight measurement, indirect calorimetry measurement to determine the energy needs of your body and a urine pregnancy test (women only).
  • Dietician Visit: If you qualify for the study, you will return to meet with the research dietician to be taught an individualized diet that you will follow for 7 days prior to the next study visit in order to maintain your body weight. You will also be asked to record your food intake and physical activity for the 7 days prior to the next study visit.
  • Procedure Day Visit: This 6-hour visit will include height, weight, waist circumference and hip circumference measurement, blood draw (8 tablespoons over 4 hours), infusion test, indirect calorimetry and abdominal fat tissue biopsy.

Specific Inclusion Criteria include: 1) Men and women age 18-50; 2) Body Mass Index 20-40; 3) No diabetes, heart disease or anxiety disorder. Financial compensation is provided.

Randomized Controlled Trial of Breakfast Recommendations on Weight: A Multi-Site Effectiveness Trial (Closed to Enrollment)

This is a multi-site randomized controlled trial comparing the effect of recommending breakfast consumption on body weight. The proposed study will be conducted over 16 weeks. If you qualify for the study, you will be randomized to 1 of 3 groups: 1) Breakfast (eat breakfast before 10:00 am every day); 2) No Breakfast (do not eat any calories before 11:00 am every day); or 3) Control (do not change your current breakfast habits). After completing an in-person Screening Visit, you will receive follow up phone calls 4, 8 and 12 weeks after your visit. These calls will last 10-20 minutes each, depending on whether or not you have experienced any problems since your last contact with study staff. You will be asked to come back to the clinic after the 16-week period for one final in-person visit. At this time, you will be asked how well you have followed the study instructions, and your weight will be measured. Financial compensation will be provided.

Reducing Obesity in Postpartum Women (RENEW) Study (Closed to Enrollment)

The purpose of this study is to develop a weight loss program for women of color after they give birth at Boston Medical Center. This weight loss program will have weekly group classes over a 3-month period. Topics will include healthy cooking, breastfeeding practices, and stress management. We will also include 30 minutes of exercise at each group session. Participants will be given a woman called a Birth Sister to help them with getting to and from the classes and she will provide childcare during the class. Half of the participants will be assigned to the weekly in-person group classes. Everyone in the study will complete 3 research visits: one before delivery, one 6 weeks after delivery and the last 19 weeks after delivery. At these visits, participants will complete questionnaires about your overall health, eating habits and physical activity. Financial compensation is provided.

Surgical Research Studies

Osteoarthritis Findings Before and After Bariatric Surgery (OABS) Study (Closed to Enrollment)

The purpose of this study is to look at how knee and hand pain are affected by weight loss. To participate, you must be 25-60 years old, have knee pain on most days of the past 30 days in at least one knee and either be pre-approved for weight loss surgery at Boston Medical Center or a patient of the Nutrition and Weight Management Center at Boston Medical Center. You also must not have rheumatoid arthritis (RA) or other forms of inflammatory arthritis. There are two study visits over one year. All participants will receive MRI scans, ultrasounds and blood work. Financial compensation is provided.

For more information, please contact Rena Wiesen at 617-638-5921 or [email protected].

Assessment of Bariatric Surgery (ABS) Study (Closed to Enrollment)

The purpose of this study is to better understand how patients who are thinking about having weight loss surgery feel about their health and weight before and after their weight loss surgery. To participate, you must be a patient of the Bariatric Surgery Clinic at Boston Medical Center and be thinking about having weight loss surgery in the future. This study involves up to four telephone surveys in the first year and one survey a year for up to three years.

Below is a list of other industry-sponsored studies that were completed within the past two years:

ENDO Trial

This study was enrollment patients who were overweight and taking oral medications for type 2 diabetes. The trial was evaluating EndoBarrier - an investigational, non-surgical medical device designed to decrease blood sugar. To learn more visit http://www.endobarriertrial.com/.

Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study (Study is open at other sites)

This study is sponsored by Aspire Bariatrics, Inc. and is a multi-center, randomized, controlled, open-label, 52-week trial. The purpose of this study is to test the effectiveness of a new investigational treatment for obesity with a device, called the AspireAssist Aspiration Therapy System. Aspiration Therapy reduces the calories absorbed by the body by allowing one to drain a portion of one’s stomach contents after a meal. Detailed information about the device can be found at http://www.aspirebariatrics.com/. Participants will also receive lifestyle therapy counseling. To qualify, you must be interested in losing weight and have had failed at previous attempts to lose weight. The study will have up to 17 study visits during a 52 week period. Visits will include exams such as bone density analysis, blood work, EKG and physical exams.

Orexigen NB-CVOT

This study is formally known as “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR” and is sponsored by Orexigen Therapeutics, Inc.

The purpose of this study is to look at the effects of a combination investigational weight loss drug, naltrexone and bupropion, on cardiovascular death, heart attack, and stroke in overweight and obese patients who are at a higher risk of having these events because they have diabetes and/or a disease of the heart and blood vessels. The combination investigational weight loss drug will be compared to placebo and you have a 50% chance of being assigned to the investigational drug. This study requires up to 14 visits over a five-year period. During the screening process your height, weight, waist circumference, blood pressure/pulse will be recorded and a complete medical history will be taken. You will also participate in a weight management program even if you are assigned to placebo, provide data using the phone or internet, and have your blood pressure and weight loss monitored at future study visits. Financial compensation is provided.

INSPIRE ME IAA

This study is formally known as “INternational Study of Prediction of Intra-Abdominal Adiposity and its RElationships with CardioMEtabolic Risk / Intra-Abdominal Adiposity” and was sponsored by Sanofi-Aventis U.S.

The purpose of this study is to determine the relationship between the quantity of intra-abdominal adipose tissue and the potential occurrence of diabetes and cardiovascular diseases over a period of 3-years. The study will also enable to assess the association between the quantity of intra-abdominal adipose tissue and the presence of other classical cardiovascular risk factors such as high blood sugar level, blood fat levels, hypertension, albumin in the urine (a protein commonly found in the blood), smoking, family history of cardiovascular events and lack of physical exercise. Looking at these associations may help to determine which parameters best predict the occurrence of a cardiovascular event or diabetes. The intra-abdominal adipose tissue will be determined by measuring waist circumference using a tape measure and by quantifying the intra-abdominal adipose tissue by performing a CT-scan.

Amylin DFA102/E

This study is formally known as “A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction with Pramlintide in Obese and Overweight Subjects” and was sponsored by Amylin Pharmaceuticals, Inc.

The purpose of this study is to examine the safety and effectiveness of injecting two study drugs, metreleptin and pramlintide, given at the same time, compared to injecting a single drug (metreleptin or pramlintide) and a placebo (a medically inactive substance) injection, or placebo alone. The study requires measurement of blood pressure, pulse, waist circumference, measure blood sugar, insulin, cholesterol, triglycerides, hs CRP (measures inflammation). Participants are asked about mood, depression and anxiety, your quality of life, eating habits and sleep patterns. Body composition will also be measured. The study was granted a 6 month extension period to examine the long-term safety and effectiveness of these two medications.

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