Leila Saldanha

National Institutes of Health

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Johanna Dwyer

Tufts University

Karen Andrews

Agricultural Research Service

Rebecca B. Costello

Office of Dietary Supplements

Joseph M. Betz

Office of Dietary Supplements

Pamela Pehrsson

Beltsville Human Nutrition Research Center

Joanne M. Holden

Beltsville Human Nutrition Research Center

Janet M. Roseland

Agricultural Research Service

Regan L Bailey

Center for Advancing Health

Larry W. Douglass

Michigan State University

Cuiwei Zhao

Beltsville Human Nutrition Research Center

Cooperative Institutions

National Institutes of Health

Office of Dietary Supplements

Beltsville Human Nutrition Research Center

Agricultural Research Service

United States Department of Agriculture

Beltsville Agricultural Research Center

Center for Food Safety and Applied Nutrition

National Cancer Institute

Centers for Disease Control and Prevention

United States Department of Health and Human Services

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Fiber in the Diet of US Children: Results of National Surveys

PEDIATRICS (1995)

Leila Saldanha

Because fiber intake among children in the United States is poorly documented, our objectives were to determine intakes and sources of fiber in the diets of children 2 to 18 years of age and to examine the trends.We used the US Department of Agriculture's 1977 to 1978 and 1987 to 1988 Nationwide Food Consumption Surveys for our analysis. Children were classified by age and gender groups, 2 to 5 years, 6 to 11 years, boys 12 to 18 years, and girls 12 to 18 years. The percentages of children meeting the American Health Foundation's fiber recommendations for children were also determined.Analyses of the US Department of Agriculture's 1977-1978 and 1987-1988 survey data indicate that (1) large percentages (55% to 90%) of children are not meeting minimum fiber intake recommendations established by the American Health Foundation; (2) mean fiber intakes declined between 1977-1978 and 1987-1988; (3) fiber from fruits and vegetables declined during this period; and (4) fiber from grains, especially from ready-to-eat breakfast cereals, increased significantly. The results also show that eating breakfast contributes to meeting daily fiber recommendations.Given the importance of fiber in promoting optimum gastrointestinal function in childhood and in treating chronic diseases such as heart disease, diabetes, and cancer in adulthood, the trends documented in this article are disturbing and suggest that efforts are needed to encourage the consumption of fiber-rich foods among children.

Consumption

10.1542/peds.96.5.994

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Citations (108)

Use of Highly Fortified Products Among US Adults

Nutrition Today (2015)

Rebecca B. Costello Johanna Dwyer Regan L Bailey Leila Saldanha Steven P. French

It is complicated to ascertain the composition and prevalence of the use of highly fortified food and supplement products (HFPs) because HFP foods and HFP supplements have different labeling requirements. However, HFPs (energy bars, energy drinks, sports drinks, protein bars, energy shots, and fortified foods/beverages) are popular in the United States. A Web-based survey balanced to reflect US census data was used to describe their use in a sample of 2355 US adults older than 18 years in 2011 and trends in their use from 2005. In 2011, 33% of adults reported using HFPs; use was significantly higher among males, African Americans, Hispanics, and more highly educated individuals (eg, some college or more) and those younger than 45 years compared with nonusers. Multiple product use was common. Of users, 46% consumed sports drinks, 37% fortified foods/beverages, 32% protein bars, 27% energy drinks, 24% energy bars, and 12% consumed energy shots. For those HFP products as a group, prevalence of use was 36% (n = 2039) in 2005, 35% in 2009 (n = 2010), and 30% in 2011 (n = 2355). Although use was significantly lower in 2011 than in 2005 especially among females, non-Hispanics, and those with high school education or less (P ≤ .05), HFPs, particularly energy and sports drinks, continue to be widely used by many US adults.

Energy density

10.1097/nt.0000000000000129

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Citations (6)

Do single‐ and multi‐ingredient botanical dietary supplements containing green tea pass the United States Pharmacopeia's (USP) disintegration and dissolution requirements?

The FASEB Journal (2017)

P. A. Gusev Karen Andrews Sushma Savarala Phuong‐Tan V Dang Laura Oh

The bioactivity of dietary supplements (DSs) is determined by the active ingredient (AI), amount of AI and by the design and performance of the dosage form into which the AI is incorporated. As a part of the Botanical Initiative for the Dietary Supplement Ingredient Database (DSID; http://dsid.usda.nih.gov ), DSs containing green tea (GT) extract and/or GT leaf as primary ingredients (GT‐1 DSs) or in combination with other ingredients (GT‐2 DSs) were tested using USP disintegration and dissolution protocols (chapter <2040>). These tests detect problems with ingredient release that may arise due to coatings, lubricants, disintegrants, lot to lot over drying, and over compression. These tests are not intended to directly predict DS performance in the gastrointestinal tract or bioavailability. We evaluated whether single‐ and multi‐ingredient GT DSs met USP specifications for disintegration and dissolution. Six units of each DS were individually immersed and agitated in designated solutions. A formulation passed a disintegration test if, after ½ hour, remaining material had fragments of coating or capsule shell but not a palpably firm core. Dissolution tests measured the amount of epigallocatechin gallate (EGCG) in the agitation medium. A formulation passed this test if, after 1 hour, ≥ 75% of the EGCG amount was accounted for in the solution. The overall disintegration pass rate in GT‐1 lots 1–3 was 56.7% (47 out of 83 tests). Of 29 products tested in 2 lots, 16 passed and 12 failed in both lots. Of 22 products tested in 3 lots (3 rd lot purchased one year later), 8 products passed and 7 failed in all 3 lots. The overall pass rate in GT‐2 lots was 65.4% (51/78). Of 36 GT‐2 products, 21 passed and 10 products failed in both lots. Results for the remaining DSs were inconsistent. Most caplets and tablets in GT‐2 DSs failed to disintegrate. For gelatin capsules and soft gels, the pass rates were high in both GT‐1 (25/32) and GT‐2 DSs (12/13). For non‐gelatin capsules (mostly cellulose‐based), the pass rate was high in GT‐2 (24/31) but low in GT‐1 DSs (21/47). Importantly, we observed consistent disintegration results across duplicate samples. All 24 GT‐1 DSs from lot 3 failed the dissolution tests under the three conditions (pH 1.2; 4.8 or 6.4, with no enzymes added to the media, 75 paddle RPM). Products that passed the disintegration tests showed somewhat higher mean dissolution rates than those that failed (pH 1.2: 35.7 ± 20.7 vs. 3.4 ± 4.68, % EGCG dissolved, mean ± SD). We explored the effect of an additional 1 hr. of agitation, but this only marginally increased the mean percent dissolved EGCG. Gelatin hard shell capsules tended to release more EGCG than non‐gelatin vegetarian capsules (pH 1.2: 42.5 ± 17.2 vs. 8.3 ± 13.9). Thus, none of the GT DSs passed USP dissolution test and many failed to disintegrate. The consistent disintegration results across the duplicate samples demonstrate its utility for evaluating this aspect of GT DS quality control across the product lots. Support or Funding Information ARS/USDA & ODS/NIH Y1CN501006

Ingredient

Green tea extract

10.1096/fasebj.31.1_supplement.647.15

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Progress in the Development of Federal Resources to Assess Dietary Supplement (DS) Exposures

The FASEB Journal (2013)

Johanna Dwyer Karen Andrews Regan L Bailey Joseph M. Betz Vicki Burt

Accurate total exposure estimates are necessary to examine the role of nutrients and bioactives with health outcomes, as well as to monitor safety. Objective Review progress in the development of methods and databases to assess exposures from DS. Method Stakeholder meetings and workshops; and an ad hoc Federal Working Group suggest and guide product development. Results DS intakes have been added to the NHANES 24‐hr recall questionnaire. An analytically validated DS composition database (DS Ingredient Database) is publicly available through the NLM web portal, which contains adult and child multi‐vitamin and mineral (MVM) DS and calculators to compare declared label with estimated analytical values. OTC prenatal MVM and omega‐3 supplements are now being added. A DS Label Database is under development, with full label information from virtually all DS products offered for sale in the US, and links to a structured vocabulary for indexing DS. A MyDS app lets consumers’ record products they take. Conclusion These resources will help researchers accurately assess exposure to nutrients and bioactives from DS. Funding: Office of Dietary Supplements, National Institutes of Health

Dietary supplement

Ingredient

10.1096/fasebj.27.1_supplement.242.3

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Dietary supplement ingredient database (DSID): Preliminary USDA studies on the composition of adult multivitamin/mineral supplements

Journal of Food Composition and Analysis (2007)

Janet M. Roseland Joanne M. Holden Karen Andrews Cuiwei Zhao Amy Schweitzer

Multivitamin

Ingredient

Dietary supplement

Food composition data

Fortified Food

Dietary Reference Intake

10.1016/j.jfca.2007.07.009

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Citations (47)

Commonly reported US adult multivitamin/mineral (MVM) products: analysis of labeled vs. analytical values for 19 vitamins and minerals

The FASEB Journal (2008)

Karen Andrews Janet M. Roseland Cuiwei Zhao Amy Schweitzer Joanne M. Holden

Adult MVM products, representing over 55% of national market share, were analyzed for nutrient content. Nationally representative samples of each product were obtained in 6 retail locations. Products were sent to independent laboratories for analysis, along with quality control materials. For each nutrient, mean percent differences from label (%DL) and among‐lot variability were calculated. To identify patterns of variance, regression analyses were conducted for %DL vs. labeled values for the 35 products. For 12 nutrients (calcium, copper, iron, magnesium, manganese, niacin, phosphorus, potassium, riboflavin, vitamin C, alpha‐tocopherol, and zinc), mean %DLs for all products were <12%. For 7 nutrients (selenium, vitamin B6, chromium, thiamin, vitamin B12, folic acid, iodine), mean %DL values ranged from 14% to 46%. Future study will include the regression analysis of data for MVM products that garner a lower market share to determine if variance patterns can be used to predict %DL for products to be included in the Dietary Supplement Ingredient Database. This research was funded by USDA and the Office of Dietary Supplements at the National Institutes of Health.

Multivitamin

Niacin

10.1096/fasebj.22.1_supplement.159.4

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Measurement of Epigallocatechin Gallate (EGCG) and Caffeine Content of 32 Green Tea Dietary Supplements for the Dietary Supplement Ingredient Database (DSID)

The FASEB Journal (2016)

Karen Andrews P Dang Sushma Savarala P. A. Gusev Fei Han

According to the 2007–10 NHANES, 7.5% of the US population reports botanical dietary supplement (DS) use. The DSID provides analytically‐derived estimates of the ingredient contents of DS. Commonly consumed and frequently studied, green tea (GT) DS were chosen as the first botanical DS for the DSID botanical initiative. The most abundant GT constituents are the catechins, especially EGCG, and caffeine. Our goal was to evaluate methods of analysis for individual catechins, caffeine and other GT constituents of interest, decipher patterns in constituent content labeling, and examine relationships between label claims and measured phytochemical constituent content. Current labeling regulations require information on the amount of each botanical or botanical extract present in a DS. Claims about the concentration of naturally occurring phytochemical constituents of the botanicals or botanical extracts in the products are not mandatory. For researchers to more accurately estimate phytochemical intake from DS, the content of these constituents should be measured. DS that contained GT as the only or primary botanical were selected for analysis in order to minimize interferences from sources of the same phytochemicals in non‐GT ingredients. Two lots of 32 DS purchased in various market channels and in a variety of forms (27 capsules, 2 liquids, 1 tablet, 1 softgel, 1 powder) were sent for analysis to 3 laboratories. Quality control results from all three laboratories showed good agreement with certified values for GT Standard Reference Materials ® , indicating that methods employed by the laboratories can produce reliable and consistent data. As required, all 32 DS listed the weight of GT leaf/extract on the label, but a wide range (0.5–309.5 mg/serving) of EGCG content was found for the most common GT content claim (500 mg per serving, n=9). Eighteen of 32 DS voluntarily listed EGCG content on the label. Twelve products had only 1 listed source of EGCG, and amounts of EGCG in 9 of 12 were within ± 20% of label claim. The remaining 6 DS claimed an additional botanical source of EGCG but lacked information for its EGCG content. ANOVA indicated that the measured EGCG amount (mg/serving) in DS without EGCG label claims was significantly different from EGCG measured in DS with an EGCG claim on the label (for both single and two GT EGCG sources; 60 ± 53, 216 ± 146 and 141 ± 41, mean ± SD, respectively; p<0.05). The measured amount of EGCG in the latter two DS groups was not significantly different (p>0.05). The caffeine content (mg/serving) measured in DS without caffeine label claims (n=25) was lower than in DS with such claims (n=7) (means: 30 and 14, medians: 36 and 5, respectively; Kolmogorov‐Smirnov test, p = 0.02). Thus, different label formats for GT DS may differ in their predictive strength for analytical constituent content. Labels that provide only the amount of GT leaf or extract may not permit accurate estimates of GT phytochemical constituents and are thus less informative for phytochemical intake estimates from DS. Support or Funding Information Funding: ARS/USDA & ODS/NIH Y1CN501006

Ingredient

Phytochemical

Epicatechin gallate

Dietary supplement

10.1096/fasebj.30.1_supplement.423.3

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Citations (1)

Comparison of label vs. analytical values for 23 vitamins and minerals in adult multivitamin/mineral (MVM) products for the Dietary Supplement Ingredient Database (DSID)

The FASEB Journal (2007)

Karen Andrews Janet M. Roseland Cuiwei Zhao Amy Schweitzer Joanne M. Holden

Representative adult MVM products (n>2 vitamins) reported in NHANES 2001–02 were chemically analyzed for 23 nutrients in order to evaluate the relationship between their label and analytical levels. A total of 240 MVM products were purchased based on commonly reported % Daily Value (DV) levels, repackaged and sent to an independent laboratory, along with control materials and blinded duplicate products. Most of the vitamins were analyzed by validated HPLC methods, while most of the minerals were analyzed by ICP. Laboratory results were statistically evaluated at each % DV level (n=6 products) and for each nutrient (typically n=18 or 24). Four nutrients had mean % difference from label values that were >20% above label and significantly different from label for at least 2 of the %DV levels analyzed: vitamin E (62%), thiamin (25%), selenium (24%) and vitamin B6 (23%). For iron, niacin, zinc, vitamin C, phosphorus, potassium and manganese, the mean % difference from label and standard deviation were both less than 10%, indicating that the analytical results for these nutrients in MVM products were consistently close to labeled levels. Results were more variable for the other vitamins and minerals studied. These data will be combined with results from an on-going analytical study of adult MVMs (n≥9 vitamins) to evaluate nutrient variability for an analytically verified DSID. Funding: USDA & ODS/NIH Y1CN5010

Multivitamin

Niacin

Fortified Food

Ingredient

Reference Daily Intake

Dietary Reference Intake

10.1096/fasebj.21.5.a52-b

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Citations (2)

Testing Usability of the Dietary Supplement Label Database(DSLD): A Resource for Consumers, Professionals, and Researchers

Journal of Nutrition Education and Behavior (2017)

Nancy Potischman Silvia Salazar Jake Susser Leila Saldanha Johanna Dwyer

Table (database)

10.1016/j.jneb.2017.05.177

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Citations (5)

Notes and News

Journal of African Law (1970)

A. N. Allott Mr Justice Leila Saldanha Mrs Rogers

An abstract is not available for this content so a preview has been provided. As you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

Content (measure theory)

10.1017/s0021855300004642

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Citations (1)