MINUTES OF THE NUTRITION COORDINATING COMMITTEE (NCC) …

         MINUTES OF THE NUTRITION COORDINATING COMMITTEE (NCC)
              MEETING, NATIONAL INSTITUTES OF HEALTH (NIH)
              Rockledge 2, Conference Room 9112-9116, Bethesda MD
                         January 6, 2005, 2:00-4:00 PM

WELCOME
Dr. Van Hubbard, Director, Division of Nutrition Research Coordination (DNRC),
convened the meeting at 2:00 PM and welcomed the participants to the first NCC
Meeting of 2005. Dr. Hubbard asked the participants to identify themselves and
to introduce guests and new attendees. Participating via teleconference were Dr.
Joan McGowan, National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS); Dr. Elizabeth Maull, National Institute of Environmental
Health Sciences (NIEHS); Dr. M Vogel-Taylor, NIH Office of the Director; Dr. Deb
Galuska, Centers for Disease Control and Prevention (CDC); Ms. Jennifer Weber
and Ms. Kim Stitzel, Department of Health and Human Services (DHHS) Office of
Disease Prevention and Health Promotion (ODPHP); Dr. Karl Friedl and Major
Lori Sigrist, Department of Defense (DoD); and Dr. Shirley Blakely (Food and
Drug Administration (FDA) on detail to the DoD.
    The agenda for the meeting is provided as Appendix A, and the list of
attendees is provided as Appendix B. Dr. Hubbard made some changes to the
order of the agenda items to accommodate several people who wanted to hear
the discussion on Vitamin E, but would not be available until 2:30 PM.

APPROVAL OF MINUTES FROM THE NOVEMBER 4, 2004 NCC MEETING
Minutes from the November 4, 2004, NCC Meeting had previously been sent to
NCC members via email. Dr. Hubbard asked if there were any corrections to the
minutes. There were none. Dr. John Milner, National Cancer Institute (NCI),
made a motion to approve the minutes, and Dr. Paul Coates, Office of Dietary
Supplements (ODS), seconded the motion. The minutes were thus approved
and will be posted on the DNRC website, http://www.dnrc.nih.gov along with the
minutes from previous NCC Meetings.

STATUS OF OXYGEN-18 FOR USE IN ENERGY EXPENDITURE AND OTHER
MEASURES
Dr. Rick Troiano, NCI, provided information about the availability of oxygen-18 for
use in research on energy expenditure and other studies. Dr. Troiano and Dr.
Sergei Romashkan from the National Institute of Aging (NIA) met with the US
distributor and Israeli marketing manager for Rotem, one of the producers of
oxygen-18. This company, which had previously indicated that they would focus
on the PET market and had no interest in selling the low-enrichment isotope
used for doubly-labeled water studies, is now actively seeking orders for low-
enrichment (10%) isotope. Rotem wants researchers to know that the price for
the isotope has come down (to roughly $5-7 per gram, depending on quantity)
and that availability is not a problem. Relatively large quantities of the isotope
could be delivered within a few months, rather than years, as was the case over
the past several years. Smaller amounts appear to be immediately available.
The pricing/availability situation is unlikely to be limited to this producer. Please
share this information with other researchers who may be avoiding the use of
doubly-labeled water because of concerns about lack of availability.

UPDATE ON FOOD AND DRUG ADMINISTRATION (FDA) HEALTH CLAIMS
AND OTHER ISSUES
Dr. Kathy Ellwood, FDA, discussed an article entitled "New Food and Drug
Administration Health Claim Requirements Get Mixed Response" by Damon
Brown published in the January 2005 Issue of the Journal of the American
Dietetic Association (Volume 105, Number 1, pages 19-20) and noted that some
of the information in the article was not correct. Currently, there is no FDA
proposed rule for health claims. The results from some FDA studies about
consumer understanding of health claims are being evaluated and will be
presented by the FDA Consumer Studies Group at a later date. At the present
time, FDA is working under an interim guidance system for health claims. Health
claims that are permitted by FDA are listed on the FDA website
(http://www.cfsan.fda.gov/label.html). FDA issued letters of enforcement
discretion for omega-3 fatty acids and coronary heart disease last fall and for
monounsaturated fatty acids in olive oil and coronary heart disease last October.
Eleven qualified health claims are under review and are listed on the FDA
website.

VITAMIN E: RECENT RESEARCH FINDINGS/CURRENT CLINICAL TRIALS
Dr. Maria Sgambati, NCI, and Dr. Paul Coates, ODS, led a discussion with NCC
attendees about a paper that appeared in the January 2005 issue of Annals of
Internal Medicine entitled "Meta-Analysis: High-Dosage Vitamin E
Supplementation May Increase All-Cause Mortality" by Edgar R Miller et al.
(http://www.annals.org/cgi/content/full/0000605-200501040-00110v1). This
paper provided the results of a meta-analysis of the dose-response relationship
between vitamin E supplementation and total mortality using data from 19
randomized, controlled trials. The paper concluded that high-dosage (>400 IU of
vitamin E per day) vitamin E supplements may increase all-cause mortality and
should be avoided.
    This paper was of particular concern to NIH because of an on-going clinical
trial, the SELECT trial, being conducted by NCI and co-sponsored by the
National Center for Complementary and Alternative Medicine (NCCAM) several
other Institutes and Centers. Dr. Sgambati noted that the SELECT trial is
evaluating the effects of selenium, vitamin E, selenium plus vitamin E, and a
placebo on the occurrence of prostate cancer. The level of vitamin E used is 400
units of d-alpha-tocopherol acetate. The subjects are men at high risk for
prostate cancer and will be in the study for seven to 12 years; the men are
currently in the second year of the study. Because the paper generated a lot of
attention from the participants, NCI sent letters to them indicating that the level of
vitamin E being used in the trial is safe. The trial is still on-going and may be
accompanied by more cautious monitoring.




                                          2
     Dr. Coates noted that because meta-analyses allow for the pooling of data,
they may demonstrate effects not otherwise seen in the individual studies. There
are rules for pooling, and it is not clear exactly how these rules were followed in
the paper being discussed. Of particular interest are the differences in the
lifestyles and geographic locations of the study participants, the health of the
participants, the purpose of the studies, the amount and form of vitamin E that
was supplemented, and the complexity caused by interventions other than
vitamin E. It is possible that the results of the meta-analysis might have been
compromised due to these factors. The paper, which was first made available
electronically, has resulted in a number of letters to the editor. Dr. Coates said
that the current ODS and Clinical Center fact sheet on vitamin E will be reviewed
to determine if any changes are necessary.
    Dr. Hubbard said that many NIH researchers might be interested in this
vitamin E meta-analysis because there have been 142 NIH-funded studies over
the past five years, some of which used vitamin E as an intervention. A number
of these studies involved the relationship of vitamin E to cardiovascular risk,
Alzheimer's Disease, eye disease, and nonalcoholic steatohepatitis in the obese.
When establishing the tolerable upper levels for vitamin E, The Dietary
Reference Intake (DRI) review, found no evidence of harm at 1000 units per day.
Also of interest is the fact that the requirement for vitamin E cannot be easily
achieved by the usual diet; perhaps the DRIs are too high. Also of interest are
vitamin E and K interactions and potential implications for bone health.
     Dr. Judy Finkelstein, NIA, noted that in two NIA-funded trials using 2000 units
of vitamin E per day, no harmful effects were seen. A paper published from one
of these studies on Alzheimer's disease and vitamin E found no effect of vitamin
E on cognition, but a longer time to nursing home stays. The publication for the
second trial is being drafted, but again, it found no effects of vitamin E on
cognition.
     Dr. Hubbard and the group discussed plans for a vitamin E workshop or
conference. Those who want to be involved in the next steps should let Dr.
Hubbard know, and he will arrange a conference call.
     Recent papers on vitamin E discussed at the meeting include:
Miller ER, et al. Meta-analysis: high-dosage vitamin E supplementation may
   increase all-cause mortality. Ann Intern Med 142:37-46, 2005 (plus
   accompanying editorial by ER Greenberg, Ann Intern Med 142:75-76, 2005).
Vivekananthan DP, et al. Use of antioxidant vitamins for the prevention of
   cardiovascular disease: Meta-analysis of randomised trials. Lancet 361: 2017-
   2023, 2004.
Knekt P, et al. Antioxidant vitamins and coronary heart disease risk: A pooled
   analysis of 9 cohorts. Am J Clin Nutr 80: 1508-1520, 2004.
US Preventive Services Task Force: Vitamin Supplementation to Prevent Cancer
   and Cardiovascular Disease - Counseling.
   http://www.ahrq.gov/clinic/uspstf/uspsvita.htm#related.




                                         3
UPDATE OF THE NIH OFFICE OF DIETARY SUPPLEMENTS (ODS)
Dr. Paul Coates, ODS, announced that the first meeting of a newly-constituted
Trans-NIH/Agency Dietary Supplement Liaison Working Group will be held on
January 27, 2005 from 1:30-3:00 PM in the Neurosciences Center on Executive
Boulevard in Bethesda, Maryland. Under the leadership of Dr. Ken Fisher, ODS,
this group consists of liaison members from all NIH Institutes and Centers (ICs),
as well as from other agencies of the Federal government with an interest in
dietary supplement research.
    The need for additional avenues of communication between the ICs and
agencies with whom ODS collaborates was identified in the ODS Strategic Plan
for 2004-2009. The Trans-NIH/Agency Working Group is being organized as a
key mechanism to communicate needs and opportunities for research and to
facilitate ODS partnering with ICs and agencies that have common goals
related to dietary supplements.
    ODS sponsors a monthly seminar series; upcoming speakers include Dr.
Tsunenobu Tamura, on sabbatical to ODS from the University of Alabama
Birmingham, on January 19, 2005; Dr. Jim Harnly, USDA Agriculture Research
Service (ARS), on February 9, 2005; Dr. Irvin Rosenberg, Jean Mayer USDA
Human Nutrition Research Center at Tufts University, on March 9, 2005; and Dr.
Barry Halliwell, National University of Singapore, on April 13, 2005. Details about
topics, times, and locations are attached as Appendix C.

UPDATE OF THE US 2005 DIETARY GUIDELINES FOR AMERICANS
Ms. Jennifer Weber and Ms. Kim Stitzel from the DHHS ODPHP provided a brief
update about the publication of the 2005 Dietary Guidelines for Americans. They
noted that the Guidelines will be released in mid-January and that there will be a
media advisory two days before the release. There will be an internal briefing
after the media advisory. Some consumer materials (being developed by Porter-
Novelli) will be released at the same time as the Guidelines policy document. Dr.
Hubbard noted that the process for the 2005 Guidelines is different than that from
previous years, and that NIH has not formally cleared the policy document.

UPDATE OF DNRC ACTIVITIES
Nutrition Education Subcommittee. Dr. Jean Pennington, DNRC, provided an
update of the activities of the NIH Nutrition Education Subcommittee (NES).
During 2004, the NES reviewed 31 documents including14 from NIH, five from
USDA, four each from CDC and the Health Research and Services
Administration (HRSA), two from DHHS, and one each from the Administration
on Aging (AoA) and the DHHS Office of Women's Health. Of the 14 documents
from NIH, there were three each from the Weight-control Information Network
and NHLBI, two each from NIDDK, NCI, and NICHD, and one each from the
Clinical Center and ODS. Documents reviewed or under review since the
November 2004 NCC meeting include:
 - Adolescent Nutrition CD-ROM (Food and Nutrition Service, USDA)
 - Bright Futures for Women's Health and Wellness Materials (HRSA)




                                        4
     Dr. Pennington requested that NCC members look at the DNRC website
(www.dnrc.nih.gov) under "Nutrition Education" to determine if the links and
information presented for their IC need to be updated. This information is
reviewed yearly, and any updates should be sent to Dr. Pennington.
     Dr. Hubbard noted that there would be two presentations during National
Nutrition Month (March) from Dr. Brian Wansink, Department of Marketing and
Nutritional Science, University of Illinois at Urbana-Champaign, Champaign,
Illinois. Dr. Wansink will speak on environmental factors that influence food
intake. One presentation will be at the March 3rd NCC Meeting, and the other will
be a more general presentation for NIH employees and will be on the NIH
Campus.

Subcommittee on International Nutrition Research. Although Dr. Daniel Raiten,
National Institute for Child Health and Development (NICHD), was unable to
attend the NCC Meeting, he sent a note communicating that the next SCINR
meeting will be held on Tuesday, January 18, 2005 from 2:00 to 3:30 PM in the
Office of Disease Prevention (ODP) Conference Room, 2B01, 6100 Executive
Boulevard, Bethesda, Maryland.

Human Nutrition Research and Information Management (HNRIM) System
Update. Mr. Jim Krebs-Smith, DNRC, provided a status report of the HNRIM
System. He noted that the request for Fiscal Year 2004 data for HNRIM will be
issued to NIH ICs within the next few weeks. NCC representatives were asked
to carefully review their IC complete research portfolio - including contracts and
intramural research - to identify all relevant nutrition research, based on the
Interagency Committee on Human Nutrition Research (ICHNR) Definition for
Human Nutrition Research (http://hnrim.nih.gov/pdf/codesdefins.pdf). Any
questions regarding data preparation, coding, or submission of the IC report
should be directed to Mr. Krebs-Smith or Ms. Karen Regan via email or
telephone.
    The NIH is working to develop an automated Knowledge Management (KM)
system to provide a consistent method across IC's to centrally code research
projects by subject area and dollar amounts. In 2004, NIH conducted a pilot
project looking at R01s in seven ICs for 12 disease/area categories. Nutrition
was one of the categories examined. The new KM system identified less than
100 nutrition-related projects, but an examination of HNRIM records identified
over 700 R01 nutrition records, for the same ICs, in the same time period. The
pilot project is complete, and each IC has been asked to designate a
representative to the KM Committee to discuss the manner in which this system
will be implemented and to develop definitions for all disease/area categories.
The DNRC is in contact with the NIDDK representative to the KM Committee,
and hopes to be closely involved with the development of the nutrition definition.
Each NIH NCC representative is encourage to make contact with their respective
IC representative to the KM Committee to make him/her aware of the existence
of the HNRIM system that is used by all federal government agencies to code for




                                        5
nutrition research activities and to indicate that staff from the DNRC are willing to
discuss information about the system with them.

REPORTS FROM NCC MEMBERS AND LIAISIONS
Dr. John Milner, NCI, noted that one of the Stars in Nutrition Seminars will be
held on March 21, 2005 in the Lipsett Amphitheater on NIH Campus from 3:00-
5:00 PM with a presentation by Dr. Paul Talalay from the John Hopkins
University School of Medicine, who will speak on Protection Against Cancer:
Edible Plants, Genes, and Enzymes.

Dr. Cindy Davis, NCI, mentioned the workshop on Promise and Perils of
Lycopene/Tomato Supplementation and Cancer Prevention to be held February
17-18, 2005 in Bethesda, Maryland. Contact Dr. Davis (301 594-9692;
davisci@mail.nih.gov) for more information.

Dr. Elizabeth Maull, NIEHS, noted a conference on Research Needs in Infants
Fed Soy Formula on February 16-17, 2005 on the NIEHS Main Campus, Rodbell
C in Research Triangle Park, North Carolina. The contact person for this event is
Dr. Janet Archer, NIEHS (919 941-9344, ex 334; archer2@neihs.nih.gov). The
meeting will be in a small room, so please contact Dr. Archer regarding space
availability.

Dr. Sue Percival, NCI, mentioned a one-day workshop entitled Immunonutrition:
Enhancing Tumoricidal Cell Activity on March 23, 2005 in North Bethesda,
Maryland. Contact Dr. Percival for more information.

NEXT NCC MEETING
Next NCC meeting ­ The next NCC Meeting is scheduled for February 3, 2005.

ADJOURNMENT
Dr. Hubbard made a motion to adjourn the meeting, and Dr. Milner seconded the
motion. The meeting was adjourned at 3:55 pm.



LIST OF APPENDICES
Appendix A - NIH NCC Meeting Agenda for January 6, 2005
Appendix B - NCC Meeting Attendees for January 6, 2005
Appendix C - Office of Dietary Supplements 2005 Spring Seminar Schedule

17February2005draftjp




                                          6
   APPENDIX A. NIH NCC MEETING AGENDA FOR JANUARY 6, 2005
   2:00-4:00 PM, Rockledge 2, Conference Room 9112-9116, Bethesda MD

 1. Welcome........................................................................Van Hubbard
 2. Approval of November 4, 2004 NCC Meeting Minutes..........Van Hubbard
 3. Vitamin E: Recent Research Findings/Current Clinical Trials...............
       Paul Coates, ODS; Margaret Chesney, NCCMA; Maria Sgambati, NCI;
       NCC Members
 4. Update on FDA Health Claims and Other Issues........Kathy Ellwood, FDA
 5. Status of O18 for Use in Energy Expenditure and Other Measures.........
       Rick Troiano, NCI
 6. Update from the NIH Office of Dietary Supplements..............Paul Coates
 7. Update of the 2005 Dietary Guidelines for Americans...DHHS/USDA Staff
 8. DNRC Activities Update
       Nutrition Education Subcommittee................. ..............Jean Pennington
       Subcommittee on International Nutrition Research... ..........Daniel Raiten
       HNRIM ..................................................................Jim Krebs-Smith
 9. Reports from NCC Members and Liaisons.......................NCC Members
10. Next Meeting: February 3, 2005........................................Van Hubbard
11. Adjournment..................................................................Van Hubbard




                                              7
APPENDIX B. NCC MEETING ATTENDEES FOR JANUARY 6, 2005
                     Members Present Members Absent            Alternates Present
Chairperson:           V Hubbard

NIH Members:
NCI                     J Milner
NHLBI                   D Danford
NIDCR                                     R Nowjack-Rayner
NIDDK                    C Miles                               R Kuczmarski
NINDS                                     M Mitler
NIAID                    M Plaut
NIGMS                                     S Somers
NICHD                                     G Grave
NEI                                       N Kurinij
NIEHS                    E Maull
NIA                      J Finkelstein
NIAMS                    J McGowan
NIDCD                                     B Wong
NIMH                                      P Muehrer
NIDA                                      G Lin
NIAAA                                     V Purohit             R Breslow
NINR                     Y Bryan
NCCAM                    M Klein
NCRR                     S Kayar
FIC                                       N Tomitch
NCHGR                                     K DeLeon

NIH Liaison Members:
CC                       N Sebring
CIT                                       J Mahaffey
CSR                                       S Kim
NLM                                       S Phillips
OBSSR                                     D Olster
OC                                        M Stern
ODS                      P Coates
OD/ODP                   B Portnoy
OLPA
ORWH
PRCC                     M Vogel-Taylor

Agency Liaison Representatives:
CDC/NCCDPHP          D Galuska
CDC/NCHS                                  V Burt
FDA                   K Ellwood                                S Blakely
HRSA                                      M Lawler
IHS                                       T Brown
ODPHP                                     K McMurry
USDA                  M Kretsch                               D Klurfeld
DoD                                       K Friedl

DNRC: W Johnson-Taylor, S Jennels, J Krebs-Smith, J Pennington, K Regan, L Somuah, P
Starke-Reed

Guests: R Ballard-Barbash (NCI), W Barouch (NHLBI), B Bowman (CDC), TA Collins (NCI), C
Davis (NCI), J Dwyer (ODS), A Ershow (NHLBI), S Krebs-Smith (NCI), S Perceval (NCI), MF
Picciano (ODS), S Ross (NCI), H Seifried (NCI), M Sgambati (NCI), K Stitzel, T Tamura (U AL), R
Troiano (NCI), J Weber (ODPHP), A Yaroch (NCI)




                                               8
APPENDIX C. OFFICE OF DIETARY SUPPLEMENTS 2005 SPRING
            SEMINAR SCHEDULE

11:00 AM to 12:00 Noon

January 19, 2005
Tsunenobu Tamura, M.D.
Professor, Department of Nutritional Sciences
Visiting Scientist from the University of Alabama Birmingham
Office of Dietary Supplements
National Institutes of Health
Topic: Prenatal Zinc Supplementation, Fetal Growth and Neurodevelopment in Early Childhood
Location: 6100 Executive Blvd., Room 2B03

February 9 , 2005
James Harnly, Ph. D.
Research Leader, Food Composition Laboratory
Beltsville Human Nutrition Research Center
Agricultural Research Service
US Department of Agriculture
Topic: Flavonoid Analysis: The Bitter and the Sweet
Location: 6100 Executive Blvd., Room 2B03

March 9, 2005
Irvin H. Rosenberg, M.D.
Senior Scientist and Director, Nutrition and Neurocognition Laboratory
Jean Mayer USDA HNRCA at Tufts University
Topic: Vitamin B-12, Folate and Cognitive Performance
Location: Neurosciences Building, Room TBD

April 13, 2005
Barry Halliwell, Ph. D.
Director, Graduate School of Integrative Science and Engineering
The National University of Singapore
Topic: The Antioxidant Paradox: Implications for use of Dietary Supplements
Location: Neurosciences Building, Room TBD

May 11 or 18, 2005
Speaker: TBD
Topic: TBD




                                               9