Nutrition and Metabolism Studies
Our team values interdisciplinary collaborations. Current and previous collaborators include experts in cardiology, microbiology, immunometabolism, gastroenterology, cancer, physiology/biophysics, clinical epidemiology, preventive medicine, obstetrics, and minimally invasive bariatric surgery. Additionally, we continue to collaborate with individuals in Boston Medical Center’s Departments of Medicine, Surgery, Pediatrics, and Family Medicine. Please click on the study titles to read more.
“I wanted to thank you and your team for getting me into your study so quickly, and also wanted to thank everyone today for the professionalism and kindness.”
– Email from a Research Participant
Current Studies (Now Recruiting!)
The SELECT Study
Have you ever had a heart attack or stroke? Do you have poor circulation? Have you considered participating in a clinical study?
Participating in a clinical study can improve future treatment options for you and other people with cardiovascular diseases. Research has shown that treatment with semaglutide may reduce the risk of stroke and heart attack in people with type 2 diabetes. In a study called SELECT, we will check to see if semaglutide reduces the risk of cardiovascular events such as heart attack and stroke in people with overweight or obesity.
You may qualify to participate in the SELECT study if:
• You have had a brain attack (stroke), or heart attack (myocardial infarction), or have poor circulation (peripheral arterial disease)
• You are 45 years old or older
• You are living with overweight or obesity
• You are able to attend regular clinic visits and receive phone calls over a period of 3–5 years
If you qualified to participate the following would be provided at no cost to you:
• Study-related care, including regular health check-ups
• General talks with a dedicated team of doctors and nurses
• Guidance on healthy lifestyle choices
Participating in this study will not affect the care you receive at Boston Medical Center. To find out if you may qualify for this study, please take this brief screening questionnaire. If you have questions or would prefer to complete the screening questionnaire over the phone, please call Özden Özkur Akinci at 617.414.2935 or send her an email here.
The ENDO (Endocrinology, Nutrition, and Diabetes Opportunities) Registry
We are currently creating a registry of interested individuals who would like to participate in research at Boston Medical Center or Boston University School of Medicine. The option to join the registry is voluntary. Joining will not affect the care you receive at Boston Medical Center. For more information, please read the ENDO Registry Consent Form.
Estamos creando un registro de individuos interesados en participar en estudios de investigación en Boston Medical Center o Boston University School of Medicine. Participar en el registro es voluntario. Participar no afectará la atención recibida en Boston Medical Center. Para más información, por favor leer el formulario de consentimiento. Para inscribirse en el registro, por favor ingresar a https://is.gd/ENDOregistry_Spanish.
Ongoing Studies (Closed to Enrollment)
Medium Chain Triglycerides (MCT) and Metabolism
We recruited participants for a clinical trial looking at the effect of medium chain triglycerides (MCT), which are found in coconut oil, on markers of metabolism. This research provides basic knowledge on how metabolism is affected by replacing part of usual dietary fat intake with MCT. Participants had a BMI of less than 45 and could not participate if they had diabetes or took weight loss medications. Participants completed a baseline visit, where we measured blood pressure, pulse, weight, waist circumference, resting energy expenditure, body composition, and physical activity level. They also completed a frequently sampled intravenous glucose tolerance test and receive dietary counseling from a registered dietitian (RD).
During the following 6 weeks, participants used MCT oil in place of some of the fats and oils they normally use. They also had weekly phone calls with the study dietitian. At the end of the 6 weeks, participants completed all the baseline measurements again. All assessments, dietary counseling and study oil were free. Participants were paid up to $200 if they completed all scheduled study visits.
Previous Studies (Closed to Enrollment)
Nutrition Research Studies
The INDIGO Study
This clinical research study looked at the role of inflammation found in blood and fat tissue and its connection to obesity and diabetes. We enrolled participants ages 18-65 without diabetes or prediabetes, with a BMI of 18-25 or 30-45. Eligible participants completed a baseline visit, where we measured blood pressure, pulse, height, weight, and waist and hip circumference. Participants also completed a frequently sampled intravenous glucose tolerance test and a blood draw. All study participants were paid for the study visits they completed.
Muscle Tissue Study
This project sought to determine whether human muscle cells can be converted into brown fat cells. Brown fat decrease the chances of obesity in mice. Participants were between the ages of 20 and 50 years old, with a BMI of 30 or less. Samples of thigh muscle were taken under the supervision of trained clinicians and research personnel. Financial compensation was provided.
Optimizing Protein with Testosterone in Men (OPTIMen) Study
The study evaluated whether a higher amount of daily protein in men’s diets would improve muscle mass, strength and physical function. The study also assessed whether adding weekly testosterone injections further improves a man’s muscle mass, strength and physical function. Men ages 65 and older participated in this study. Participants completed 31 study visits over 7 months. Some visits included a physical exam, exercise tests and blood tests. During the study, participants received 3 meals per day and a powder supplement that they took 3 times daily. Participants were randomly assigned to receive the study medication (testosterone) or the placebo. Participants received the assigned treatment by a weekly injection. Participants were financially compensated for completed visits.
Insulin and Glucose Metabolism Study
The purpose of this study was 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. Participants were men and women ages 18 to 50, with BMIs of 20 to 40. Participants completed 3 in-person study visits: a screening visit, a dietitian visit, and a procedure day visit. Procedures included physical exams, blood draws, height and weight measurements, indirect calorimetry measurements, infusion tests, and abdominal fat tissue biopsies. Financial compensation was provided to the participants for study visits completed.
Breakfast Recommendations on Weight: A Multi-Site Effectiveness Trial
This was a multi-site randomized controlled trial comparing the effect of recommending breakfast consumption on body weight. The proposed study was conducted over 16 weeks. Participants were randomized to 1 of 3 groups: 1) Eat breakfast before 10:00 AM every day); 2) Do not eat any calories before 11:00 AM every day; or 3) Do not change your current breakfast habits. After completing an in-person Screening Visit, participants received follow up phone calls 4, 8 and 12 weeks after your visit. Participants came back to the clinic after the 16-week period for one final in-person visit. Financial compensation was provided to the participants for study visits completed.
Reducing Obesity in Postpartum Women (RENEW) Study
This study sought to develop a culturally-appropriate weight loss program for women of color after they give birth at Boston Medical Center. The program provided weekly group classes over a 3-month period. Topics included healthy cooking, breastfeeding practices, and stress management. Each group session also included 30 minutes of exercise. Participants were assigned a Birth Sister to help them get to and from the classes. The Birth Sister also provided childcare during the classes. Study participants completed 3 additional research visits: before delivery, 6 weeks after delivery, and 19 weeks after delivery. At these visits, participants completed questionnaires about their overall health, eating habits and physical activity. Financial compensation was provided to the participants for study visits completed.
Surgical Research Studies
Osteoarthritis Findings Before and After Bariatric Surgery (OABS) Study
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.
Assessment of Bariatric Surgery (ABS) Study
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.
Gelesis Loss of Weight (GLOW) and GLOW Extension Studies
BMC was one of the sites conducting a clinical research study on the effect of Gelesis100 in overweight and obese participants. Participants took the capsules daily before lunch and dinner. In addition, participants received dietary counseling for weight loss. Participants enrolled in this multi-site study are healthy individuals between the ages of 22 and 65 with an initial Body Mass Index (BMI) of 27-40. Participant involvement lasted up to 31 weeks and consisted of 14 visits. These visits included physical exams, blood tests, and questionnaires.
For the first part of the study (GLOW), participants received either the study capsules or the placebo. The product each participant received during the study was assigned randomly, like the flip of a coin. Both the study participants and the clinical personnel involved in the study were blinded to the treatment the participant received throughout the study. For the GLOW extension, the product is open-label, meaning all participants know that they will be taking the Gelesis100 capsules (not the placebo). All assessments, dietary counseling, and study products are free to participants. Participants are financially compensated for completed visits.
This study enrolled 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.
Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study
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.
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.
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.
Patients and visitors: We are now recruiting for several studies! If you are interested in hearing about studies that you may be able to participate in, please consider enrolling in the ENDO Registry. Alternatively, you may also email or contact Özden Özkur Akinci and Zhihui Ju at 617-414-2935 or 617-414-2951 .
Investigators: If you are interested in collaborating with the Nutrition and Weight Management team on a research study, please email or contact Özden Özkur Akinci and Zhihui Ju at 617-414-2935 or 617-414-2951 .