Access the resources of five Harvard Catalyst clinical research centers. Harvard Catalyst Clinical Research Center (HCCRC)

Metabolism & Nutrition Research

Mission Statement

Metabolism & Nutrition Research (MNR) provides quality nutrition research resources to investigators to facilitate metabolic research objectives and nutrition outcomes used for clinical and translational research.

Description

MNR is a resource within the Harvard Catalyst Clinical Research Center (HCCRC), supporting routine and research meals; nutrition intake data collection and analysis; and metabolic assessments using a variety of modalities. Inpatient, outpatient, and/or extended off-unit MNR facilities and personnel provide investigators a specialized infrastructure for high quality nutrition services that might otherwise be unavailable or prohibitively expensive.

Experienced research dietitians (RDs) and support staff provide MNR support to principal investigators. The RDs can help principal investigators develop research design and budgets for grant applications, review study protocols, and develop comprehensive nutrition plans including implementation procedures.

As an integral study team member, the RD educates the clinical research staff regarding the nutrition component of the study protocol, and interpretation of nutrition data. RDs can also assist with data review and manuscript preparation upon study completion.

Information for Investigators

Resources Available for Investigators

To request use of these services, use the HCCRC Protocol Review form.

Protocol Development

  • Assistance with protocol development, including grant preparation
  • Literature research into drug-nutrient interactions
  • Review of the current literature regarding the involvement of nutrients in the promotion or progression of a particular disease state
  • Evaluation of best practices for gathering study-specific nutrition information
  • Identification of particular foods that meet a study's nutritional specifications
  • Development of novel nutrition methodology
  • Development of nutrient-specific screening and assessment materials
  • Evaluation of methodology(-ies) for assessing population-specific changes in metabolic markers
  • Budget projections for nutrition services

Metabolic Assessment

  • Anthropometrics (height, weight, skin fold, and circumferences): RDs perform or help train study staff to perform procedures for collecting various anthropometric measurements using techniques and methods described in NHANES III
  • Bioelectrical impedance analysis (BIA) for hydration status and body composition
  • Energy expenditure and nutrient utilization using indirect calorimetry
  • Dual energy x-ray absorptiometry (DXA) for bone mineral density and body composition
  • Physical activity assessment
  • Exercise tolerance testing and exercise-related fitness

Nutrient Intake Collection and Analysis

Based on specific aims, the RDs can help investigators select the appropriate tools (e.g., food intake records, diet histories, food frequency questionnaires) to collect and analyze nutrient intake data.

Nutrition Counseling and Education

RDs are available to conduct study-related nutrition consultations, including:

  • Single or multiple sessions with individual subjects
  • Telephone consultations
  • Educational classes
  • Internet-based follow-up and monitoring

Metabolic Kitchen Services:

  • House Meals/Snacks: In protocols for which energy, nutrients, or specific foods are not controlled, the diet order may be "House." Subjects may choose meals off a self-selected menu or receive a standard meal/snack.
  • Weighed/Controlled Nutrient Meals: Meal plans are calculated to meet specific nutrient levels defined by the research protocol. Meal plans can be controlled for macronutrients (e.g., carbohydrate, protein, fat) and/or micronutrients (e.g., sodium, potassium, magnesium), glycemic index, or other study specifications. In order to maintain an exact nutrient intake, subjects must finish all food provided to them. No additional food or beverage intake is allowed. Specific meal plans can be developed for meal challenges or test meals.

Off Unit Services

RD/staff services are available to off-site investigators for nutrition data collection methodologies and interventions, and study staff training. Study requirements and logistics should be discussed with the MNR manager/director at the relevant HCCRC site(s).

Investigators are encouraged to consult the MNR manager/director of the HCCRC sites - who can provide the fee structure, services offered, and hours of operation - when developing grant proposal budgets. An assessment of requested services and the operating structure at each institution can also help investigators understand and budget for the MNR-related costs for specific protocols.

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Standard and Above Standard Services for Investigator-Initiated Studies*

*To be implemented for all NEW studies as of January 1, 2013

As of January 1, 2013, HCCRC is implementing a set of categories for services available for all HCCRC research investigators conducting investigator-initiated studies:

  • Standard services are free up to a certain defined level, beyond which there will be a fee incurred.
  • Above Standard services have fees incurred for use.

The description of services with their new levels is below.

Implementation

Implementation of the new Standard/Above Standard guidelines for new protocols submitted to Protocol Review January 1, 2013, or later will be immediate.

For protocols submitted to Protocol Review prior to January 1, 2013, you will be charged the old Standard/Above Standard rates and service fees until December 31, 2014. These older protocols will be required to change to the new guidelines by January 1, 2015. However if your study will benefit from the new Standard/Above Standard guidelines by incurring fewer fees under the new guidelines, you are encouraged to switch immediately.

Please note: Industry-initiated studies do not benefit from Standard Services discounts and fee-waivers.

If you have any questions regarding these changes, please contact the metabolism & nutrition research director or administrative director at your local site.

Determining Standard/Above Standard Services for Investigator-Initiated Studies


SERVICE Standard Above Standard
House Meal/Snack (each) X
Weighed Meal/Snack (each) X
1 to 1 Research Dietician Tasks ≤ 30 min > 30 min
BIA
Anthropometric Assessments
Nutrition Education
Questionnaires
Food Recalls
Food Record Analysis ≤ 60 min > 60 min
DXA X
Indirect Calorimetry ≤ 30 min > 30 min
Exercise Testing X
BOD POD X

To request use of these services, use the HCCRC Protocol Review form.

Availability of Services at HCCRC Sites*
BIDMC BCH BWH MGH
Protocol Development X X X X
Anthropometry X X X X
DXA X X
Indirect Calorimetry X X X X
Inpatient Unit X X X X
BIA X X X X
Exercise Testing X
Nutrient Intake Collection and Analysis X X X X
Nutrition Counseling and Education X X X X
Weighed/Standard Meals X X X X
Off-site Services X X X X
BOD POD X

*Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, and Massachusetts General Hospital

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HCCRC Metabolism & Nutrition Research Contacts

To discuss the MNR requirements for your study, please contact the MNR director for your institution's Harvard Catalyst Clinical Research Center site:

Beth Israel Deaconess Medical Center
Joanna Radziejowska, MS, RD, LDN
Metabolism & Nutrition Research Director
617-667-3586
Email

Boston Children's Hospital
Leigh Keating, MS, RD
Nutrition Director
617-732-7783
Email

Brigham and Women's Hospital
Leigh Keating, MS, RD
Nutrition Director
617-732-7783
Email

Massachusetts General Hospital
Ellen J. Anderson, MS, RD, LDN
Metabolism & Nutrition Research Director
617-724-2830
Email

Professional Organizations and Links

National Association of Bionutritionists
The NAB is an organization comprised of Registered Dietitians who direct the Bionutrition research services at NIH-funded research centers across the United States. The organization promotes the health of the nation through the pursuit of clinical research.

American Dietetic Association
The American Dietetic Association is the world's largest organization of food and nutrition professionals. The ADA is committed to improving the nation's health and advancing the profession of dietetics through research, education, and advocacy.

American Dietetic Association Research Dietetic Practice Group
The Research Dietetic Practice Group is an organization comprised of members who propose, assist with, complete, manage, and disseminate findings from research projects conducted in clinical, community, healthcare, laboratory, and academic settings. The group's mission is to lead the future of dietetics by promoting the conduct and application of research related to food, nutrition, and dietetics.

Association for Clinical Research Training
The Association for Clinical Research Training is an organization designed to help foster the professional growth of its members by providing a forum to discuss new developments in clinical research training methods and techniques concerning human diseases and other related matters.