Transcript Investigating the U.S. Marketability of Foreign Nutraceuticals

Profiling Dietary Supplement Use:
Current Data and Challenges
Office of Dietary Supplements Conference
Bioavailability of Nutrients and Other Bioactive
Components of Dietary Supplements: Defining
the Research Agenda
January 5, 2000
James T. Heimbach, Ph.D., F.A.C.N.
Mary M. Murphy, M.S., R.D.
Judith S. Douglass, M.S., R.D.
ENVIRON International Corporation
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2 Recent
Private Surveys
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“The Growing Self-Care
Movement”
• Telephone survey of 1000 food shoppers
• Interviewing February-March, 1999
• Sponsored by Prevention Magazine and
the Food Marketing Institute (FMI)
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“The Growing Self-Care
Movement”
(Prevention/FMI Survey)
Products used to maintain health
1998 1999
OTC medications
Vitamins & minerals
Fortified foods
Herbal remedies
Homeopathic remedies
85% 76%
67% 72%
NA 66%
28% 36%
15% 17%
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“The Growing Self-Care
Movement”
(Prevention/FMI Survey)
Vitamins & minerals
Herbal remedies
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Use to
prevent
colds
Use to
treat
colds
60%
32%
50%
34%
“Consumer Perceptions and Use
of Vitamins & Herbal Products”
• Telephone survey of 2,000 individuals age
18+
• Interviewing winter, 1998-99
• Sponsored by Leiner Health Care
Products (used by permission)
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“Consumer Perceptions and Use
of Vitamins & Herbal Products”
(Leiner Health Care Products)
Take a vitamin supplement daily
– Multivitamin
– Vitamin C
– Vitamin E
– Vitamin A
– Zinc
– Iron
55%
45%
24%
22%
3%
5%
3%
Take an herbal product daily
– Ginkgo
– Ginseng
14%
6%
5%
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“Consumer Perceptions and Use
of Vitamins & Herbal Products”
(Leiner Health Care Products)
Why take product
–
–
–
–
–
General health
Prevent illness
Compensate for poor diet
Improve energy
Improve memory
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Vitamin/ Herbal
Mineral Product
40%
30%
26%
---
41%
20%
-10%
10%
National Nutrition Monitoring
and Related Research Program
(NNMRRP)
• Established by the National Nutrition
Monitoring and Related Research Act of 1990
(Public Law 101-445)
• Encompasses “the set of activities necessary to
provide timely information about the role and
status of factors that bear on the contribution
that nutrition makes to the health of the people
of the United States.”
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National Nutrition Monitoring
and Related Research Program:
Five Components
• dietary, nutritional, and health
status measurements
• food consumption measurements
• food composition measurements and nutrient
data banks
• dietary knowledge and attitude measurements
• food supply and demand determinations
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National Nutrition Monitoring
and Related Research Program:
Keystone Surveys
• National Health and Nutrition Examination
Surveys (DHHS/CDC/NCHS)
• NHANES III, 1988-1994
• Nationwide Food Consumption Surveys
(USDA/ARS)
• Continuing Surveys of Food Intakes by Individuals
(CSFII 1994-96)
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National Nutrition Monitoring
and Related Research Program:
Other Major Surveys
• National Health Interview Surveys
(DHHS/CDC/NCHS)
• Annual NHIS (since 1957)
• Split-sample design with variable modules
• Various surveillance surveys (DHHS/CDC)
• Health and Diet Survey (DHHS/FDA)
• Special surveys
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Third National Health and
Nutrition Examination Survey
(NHANES III)
• Period covered:
– Fall 1988 to Fall 1994
• Number of respondents:
– 33,994 interviewed
– 31,311 examined
• Data obtained:
– food consumption measurements (1 day)
– dietary, nutritional, and health status measurements
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Third National Health and
Nutrition Examination Survey
(NHANES III)
Key indicators:
–
–
–
–
food & nutrient intakes
body measurements
hematological tests
biochemical analyses of
whole blood & serum
– blood pressures
– EKGs
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–
–
–
–
urine tests
bone densiometry
dental exams
gallbladder
ultrasonography
– cognitive & physical
functioning
1994-96 Continuing Surveys of
Food Intakes by Individuals
(1994-96 CSFII)
• Period covered:
– January 1994 to December 1996
• Number of respondents:
– 16,103 provided Day-1 data
– 15,303 provided 2 days of data
• Data obtained:
– food consumption measurements on two
nonconsecutive days
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Current Activities
• NHANES IV
– similar to NHANES III
– in field now
– will become continuous
• 1998 CSFII Children’s Survey
–
–
–
–
–
January 1998 to December 1998
methodology similar to 1994-96 CSFII
interviewed 5,300 children birth to 9 years
summary data released December 1999
CD-ROMs available March 2000
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Future Plan:
Unified NHANES/CSFII
• Scheduled to begin January 2001
• Continuous survey
• 10,000 respondents per year
– oversample African-American, Mexican-American, and
low-income populations
– 5,000 CATIs providing 2 days of data
– 5,000 CAPIs in the MECs providing 1 day of data; 10%
sub-sample providing 2 days
• CD-ROMs to be released approximately 15
months after completion of each year
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“… provide timely information …”
Time between surveys-NHANES I:
1971-74
NHANES II:
1976-80
NHANES III:
1988-94
NHANES IV:
1999- ?
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NFCS:
1977-78
CSFII:
1985-86
NFCS:
1987-88
CSFII:
1989-91
CSFII:
1994-96
CSFII:
2001- ?
“… provide timely information …”
Time from completion of survey fieldwork to
release of data-Old standard:
2-? years
New standard:
14-15 months
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Nutrient
Bioavailability
Not a priority ...
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Example:
Iron Bioavailability
“Non-heme iron absorption from a meal
containing meat, fish, or chicken is about
4 times greater than from equivalent
portions of milk, cheese, or eggs.”
Rossander et al., 1979
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Enhancers and Inhibitors
of Iron Absorption
+ Ascorbic acid
+ Heme iron
+ Other meat factors
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-
Phytic acid
Oxylates
Polyphenols
Calcium phosphate
Proposed Research Paradigm
• Link data on enhancers and inhibitors in
foods with USDA food codes
• Determine, for each eating occasion, the
amount of non-heme iron as well as
enhancers and inhibitors
• Employ iron absorption model to estimate
the amount of bioavailable iron
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“… factors that bear on the
contribution that nutrition makes…”
National data regarding consumer
use of dietary supplements-• in CSFII
• in NHANES
• in NHIS
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Dietary Supplements
in CSFII
“How often, if at all, do you take any vitamin
supplement in pill or liquid form? Would
you say-– Every day or almost every day,
– Every so often, or
– Not at all?”
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Dietary Supplements
in CSFII
“Which of these types of supplements do you usually
take?”
–
–
–
–
multivitamin
multivitamin with iron or other minerals
vitamin C and iron
single vitamins or minerals (list)
“Do you take a fish oil supplement?”
“Do you take a fiber supplement?”
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Dietary Supplements
in NHANES
“Have you taken any vitamins or minerals in
the past month?”
“How many vitamin or mineral products do
you take?”
[list all supplements reported, ask to see
container, record product name and
manufacturer or distributor]
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Dietary Supplements
in NHANES
“How often did you take [PRODUCT] in the
past month?”
“How much [PRODUCT] did you take each
time you took it?”
“For how long have you been taking this type
of product?”
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Dietary Supplements
in NHIS
• Questions on use of vitamin and mineral
supplements were included in 1987 and in
1992
– “Have you taken any vitamin or mineral
supplement in the past year?”
– Information was obtained on frequency of use
of multivitamins and a variety of specific
vitamin or mineral supplements
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Challenge
little change
BIG EFFECT
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Challenge
Product Identification
– Brand A
• formulation?
– Brand B
• formulation?
– Brand X
• ????????????
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Challenge
Product Characterization
Product Consistency
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Challenge
Survey Respondent Burden
Necessary
Nice to know
Can’t put EVERYTHING
into NHANES/CSFII!
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Recommendation
Examine critically the data needs for dietary
supplement ingredients-– Detailed linkage with food/nutrient intake
– General linkage with food/nutrient intake
– No needed linkage with food/nutrient intake
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Some thoughts on taxonomy...
•
•
•
•
Vitamins, minerals
Other substances found primarily in foods
Substances found in foods at low levels
Substances not found in foods, but with
known/suspected food/nutrient interactions
• Substances not found in foods and with no
suspected food/nutrient interactions
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Estimated Usual Intake of Iron
Diet Alone v. Diet + Supplements
(Source: NHANES III)
Usual Intake of Iron (mg)
Females by Age and P/L Status
60
50
40
30
20
10
0
F
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Diet Alone
13
9
F
30
19
F
70
51
F
P/
L
Diet +
Supplements
Estimated Usual Intake of Iron
Diet Alone v. Diet + Supplements
(Source: NHANES III)
120
100
80
60
40
20
0
Diet Alone
95
th
75
th
25
th
Diet +
Supplements
5t
h
Usual Intake of
Iron (mg)
Females Age 19-30 Years
Percentile of Intake
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Intake of Vitamin C From Foods
Females Age 9+
(Source: NHANES III)
Dietary Vitamin C Intake
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
LO
OK
9-13
14-18
19-30
31-50
Age
40
51-70
71+
HI
Use of Vitamin C Supplements
Females Age 9+
(Source: NHANES III)
30%
25%
20%
15%
10%
HI
5%
OK
0%
LO
9-13 14-18 19-30 31-50 51-70 71+
Age
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Use of Vitamin C Supplements
by Dietary Vitamin C Intake
1.1
15.1
100%
1.0
16.1
1.4
18.2
80%
Single
60%
83.7
40%
82.8
80.4
20%
0%
Low
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Okay
High
Multiple
None
Thank You!
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