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Featured researches published by Leila G. Saldanha.


Nutrition Reviews | 2014

Estimating caffeine intake from energy drinks and dietary supplements in the United States

Regan L. Bailey; Leila G. Saldanha; Jaime J. Gahche; Johanna T. Dwyer

No consistent definition exists for energy products in the United States. These products have been marketed and sold as beverages (conventional foods), energy shots (dietary supplements), and in pill or tablet form. Recently, the number of available products has surged, and formulations have changed to include caffeine. To help characterize the use of caffeine-containing energy products in the United States, three sources of data were analyzed: sales data, data from federal sources, and reports from the Drug Abuse Warning Network. These data indicate that sales of caffeine-containing energy products and emergency room visits involving their consumption appear to be increasing over time. Data from the National Health and Nutrition Examination Survey (NHANES) 2007-2010 indicate that 2.7% [standard error (SE) 0.2%] of the US population ≥1 year of age used a caffeine-containing energy product, providing approximately 150-200 mg/day of caffeine per day in addition to caffeine from traditional sources like coffee, tea, and colas. The highest usage of these products was among males between the ages of 19 and 30 years (7.6%, SE 1.0). Although the prevalence of caffeine-containing energy product use remains low overall in the US population, certain subgroups appear to be using these products in larger amounts. Several challenges remain in determining the level of caffeine exposure from and accurate usage patterns of caffeine-containing energy products.


Journal of the Academy of Nutrition and Dietetics | 2016

Do Cinnamon Supplements Have a Role in Glycemic Control in Type 2 Diabetes? A Narrative Review

Rebecca B. Costello; Johanna T. Dwyer; Leila G. Saldanha; Regan L Bailey; Joyce Merkel; Edwina Wambogo

Cinnamon (Cinnamomum sp) has been suggested to help patients with type 2 diabetes mellitus (T2DM) achieve better glycemic control, although conclusions from meta-analyses are mixed. To evaluate whether the use of cinnamon dietary supplements by adults with T2DM had clinically meaningful effects on glycemic control, as measured by changes in fasting plasma glucose (FPG) or hemoglobin A1c (HbA1c), a comprehensive PubMed literature search was performed. Eleven randomized controlled trials were identified that met our inclusion criteria that enrolled 694 adults with T2DM receiving hypoglycemic medications or not. In 10 of the studies, participants continued to take their hypoglycemic medications during the cinnamon intervention period. Studies ranged from 4 to 16 weeks in duration; seven studies were double-blind. Cinnamon doses ranged from 120 to 6,000 mg/day. The species of cinnamon used varied: seven used Cinnamomum cassia or Cinnamomum aromaticum, one used Cinnamomum zeylanicum, and three did not disclose the species. Because of the heterogeneity of the studies, a meta-analysis was not conducted. All 11 of the studies reported some reductions in FPG during the cinnamon intervention, and of the studies measuring HbA1c very modest decreases were also apparent with cinnamon, whereas changes in the placebo groups were minimal. However, only four studies achieved the American Diabetes Association treatment goals (FPG <7.2 mmol/L [130 mg/dL] and/or HbAlc <7.0). We conclude that cinnamon supplements added to standard hypoglycemic medications and other lifestyle therapies had modest effects on FPG and HbA1c. Until larger and more rigorous studies are available, registered dietitian nutritionists and other health care professionals should recommend that patients continue to follow existing recommendations of authoritative bodies for diet, lifestyle changes, and hypoglycemic drugs.


The American Journal of Clinical Nutrition | 2017

Analytical ingredient content and variability of adult multivitamin/mineral products: national estimates for the Dietary Supplement Ingredient Database.

Karen Andrews; Janet M. Roseland; Pavel A. Gusev; Joel Palachuvattil; P Dang; Sushma Savarala; Fei Han; Pamela R. Pehrsson; Larry W. Douglass; Johanna T. Dwyer; Joseph M. Betz; Leila G. Saldanha; Regan L Bailey

BACKGROUND Multivitamin/mineral products (MVMs) are the dietary supplements most commonly used by US adults. During manufacturing, some ingredients are added in amounts exceeding the label claims to compensate for expected losses during the shelf life. Establishing the health benefits and harms of MVMs requires accurate estimates of nutrient intake from MVMs based on measures of actual rather than labeled ingredient amounts. OBJECTIVES Our goals were to determine relations between analytically measured and labeled ingredient content and to compare adult MVM composition with Recommended Dietary Allowances (RDAs) and Tolerable Upper Intake Levels. DESIGN Adult MVMs were purchased while following a national sampling plan and chemically analyzed for vitamin and mineral content with certified reference materials in qualified laboratories. For each ingredient, predicted mean percentage differences between analytically obtained and labeled amounts were calculated with the use of regression equations. RESULTS For 12 of 18 nutrients, most products had labeled amounts at or above RDAs. The mean measured content of all ingredients (except thiamin) exceeded labeled amounts (overages). Predicted mean percentage differences exceeded labeled amounts by 1.5-13% for copper, manganese, magnesium, niacin, phosphorus, potassium, folic acid, riboflavin, and vitamins B-12, C, and E, and by ∼25% for selenium and iodine, regardless of labeled amount. In contrast, thiamin, vitamin B-6, calcium, iron, and zinc had linear or quadratic relations between the labeled and percentage differences, with ranges from -6.5% to 8.6%, -3.5% to 21%, 7.1% to 29.3%, -0.5% to 16.4%, and -1.9% to 8.1%, respectively. Analytically adjusted ingredient amounts are linked to adult MVMs reported in the NHANES 2003-2008 via the Dietary Supplement Ingredient Database (http://dsid.usda.nih.gov) to facilitate more accurate intake quantification. CONCLUSIONS Vitamin and mineral overages were measured in adult MVMs, most of which already meet RDAs. Therefore, nutrient overexposures from supplements combined with typical food intake may have unintended health consequences, although this would require further examination.


Journal of the Academy of Nutrition and Dietetics | 2014

A Free New Dietary Supplement Label Database for Registered Dietitian Nutritionists

Johanna T. Dwyer; Leila G. Saldanha; Richard A Bailen; Regan L Bailey; Rebecca B. Costello; Joseph M. Betz; Florence Chang; Jeanne Goshorn; Karen Andrews; Pamela R. Pehrsson; John A. Milner; Vicki L. Burt; Jaime J. Gahche; Constance J. Hardy; Nancy J. Emenaker

The Academy of Nutrition and Dietetics recognizes the importance of including dietary supplements in assessing and planning dietary intakes.1 Dietary supplement (DS) use in the United States has increased markedly during the last 30 years and is now widespread across all segments of society.2,3,4,5,6 Today, over half of adults and a third of US children have used one or more DS within the past 30 days, with multi-vitamin, multi-mineral (MVMM) products especially common.7, 8 Since supplements are now major sources of several nutrients such as calcium and vitamin D in American diets, it is important for registered dietitians and nutritionists (RDNs) to include their contributions when assessing intakes or planning diets.9,10,11 Likewise, for national nutrition surveillance the contributions to nutrient intakes from supplements must be considered in order to identify groups at dietary risk because their intakes fall below the estimated average requirement (EAR) or above the upper tolerable intake level (UL).12 For example, when supplements are included in assessments, the proportion of the United States population that is below the EAR is much less for several vitamins11 and fewer women are “at risk” (defined as below the EAR) for folate intake than when they are not.13,14 For some nutrients, like folic acid, the UL is established based solely for the form that comes from fortificants in foods and in dietary supplements. RDNs, epidemiologists, and public health officials also need accurate dietary supplement databases in order to evaluate possible associations between nutrient intake and disease outcomes. The National Health and Nutrition Examination Survey (NHANES) dietary supplement label database contains label-derived information from supplement products that is updated every two years. Information contained in the database is driven by what is reported by survey participants. The currently available database contains supplement label information for products reported from 1999–2010. While the NHANES DS database provides useful information, it is not comprehensive and is more likely to contain commonly used supplements and less likely to contain infrequently used supplements.15 In fact, MVMM products account for only about half of all supplements used.3 Additionally, not all information from the label is recorded and released in the database. For example, the NHANES database does not contain information such as health claims, other ingredients and warning statements that may have been on the label.


Journal of Food Science | 2015

Feasibility of Including Green Tea Products for an Analytically Verified Dietary Supplement Database

Leila G. Saldanha; Johanna T. Dwyer; Karen Andrews; Joseph M. Betz; James M. Harnly; Pamela R. Pehrsson; Catherine A. Rimmer; Sushma Savarala

The Dietary Supplement Ingredient Database (DSID) is a federally funded, publicly accessible dietary supplement database that currently contains analytically derived information on micronutrients in selected adult and childrens multivitamin and mineral (MVM) supplements. Other constituents in dietary supplement products such as botanicals are also of interest and thus are being considered for inclusion in the DSID. Thirty-eight constituents, mainly botanicals were identified and prioritized by a federal interagency committee. Green tea was selected from this list as the botanical for expansion of the DSID. This article describes the process for prioritizing dietary ingredients in the DSID. It also discusses the criteria for inclusion of these ingredients, and the approach for selecting and testing products for the green tea pilot study.


Journal of the Academy of Nutrition and Dietetics | 2017

Is Nutrient Content and Other Label Information for Prescription Prenatal Supplements Different from Nonprescription Products

Leila G. Saldanha; Johanna T. Dwyer; Karen Andrews; LaVerne L. Brown; Rebecca B. Costello; Abby G. Ershow; Pavel A. Gusev; Constance J. Hardy; Pamela R. Pehrsson

BACKGROUND Prenatal supplements are often recommended to pregnant women to help meet their nutrient needs. Many products are available, making it difficult to choose a suitable supplement because little is known about their labeling and contents to evaluate their appropriateness. OBJECTIVE To determine differences between prescription and nonprescription prenatal supplements available in the United States regarding declared nutrient and nonnutrient ingredients and the presence of dosing and safety-related information. DESIGN Using two publicly available databases with information about prenatal supplement products, information from prescription and nonprescription product labels were extracted and evaluated. For the 82 prescription and 132 nonprescription products, declared label amounts of seven vitamins and minerals, docosahexaenoic acid (DHA), the presence of other nonnutrient components, and the presence of key safety and informational elements as identified in two Department of Health and Human Services Office of Inspector General (OIG)s 2003 reports were compiled and compared. RESULTS Compared with nonprescription products, prescription products contained significantly fewer vitamins (9±0.2 vs 11±0.3; P≤0.05) and minerals (4±0.1 vs 8±0.3; P≤0.05). Declared amounts of folic acid were higher in prescription products, whereas vitamin A, vitamin D, iodine, and calcium were higher in the nonprescription products. Amounts of iron, zinc, and DHA were similar. Virtually all products contained levels of one or more nutrients that exceeded the Recommended Dietary Allowances for pregnant and/or lactating women. Product type also influenced ingredients added. Fewer prescription products contained botanical ingredients (6% prescription vs 33% nonprescription) and probiotics (2% prescription vs 8% nonprescription). Only prescription products contained the stool softener docusate sodium. CONCLUSIONS Our analysis of prenatal supplements indicates that prescription and nonprescription supplements differ in terms of declared composition and nutrient strength, but have labels that are similarly sparse regarding aspects of use such as dosing information.


Advances in Nutrition | 2016

Culinary Spice Plants in Dietary Supplement Products and Tested in Clinical Trials

Leila G. Saldanha; Johanna T. Dwyer; Joseph M. Betz

Dried plant parts used as culinary spices (CSs) in food are permitted as dietary ingredients in dietary supplements (DSs) within certain constraints in the United States. We reviewed the amounts, forms, and nutritional support (structure/function) claims of DSs that contain CS plants listed in the Dietary Supplement Label Database (DSLD) and compared this label information with trial doses and health endpoints for CS plants that were the subject of clinical trials listed in clinicaltrials.gov. According to the DSLD, the CS plants occurring most frequently in DSs were cayenne, cinnamon, garlic, ginger, pepper, rosemary, and turmeric. Identifying the botanical species, categorizing the forms used, and determining the amounts from the information provided on DS labels was challenging. CS plants were typically added as a component of a blend, as the powered biomass, dried extracts, and isolated phytochemicals. The amounts added were declared on about 55% of the labels, rendering it difficult to determine the amount of the CS plant used in many DSs. Clinicaltrials.gov provided little information about the composition of test articles in the intervention studies. When plant names were listed on DS labels and in clinical trials, generally the common name and not the Latin binomial name was given. In order to arrive at exposure estimates and enable researchers to reproduce clinical trials, the Latin binomial name, form, and amount of the CS plant used in DSs and tested in clinical trials must be specified.


British Journal of Nutrition | 2015

A select review reporting the quality of studies measuring endothelial dysfunction in randomised diet intervention trials

Rebecca B. Costello; Cynthia V. Lentino; Leila G. Saldanha; Marguerite M. Engler; Mary B. Engler; Pothur R. Srinivas; Christopher T. Sempos

A quality assessment of the primary studies reported in the literature carried out using select dietary ingredients (DI) purported to affect vascular endothelial function was conducted through a systematic PubMed search from January 2000 to August 2012. A total of seventy randomised controlled trials with defined DI (folic acid (fifteen), n-3 fatty acids (twenty), cocoa (fifteen) and isoflavones (twenty)) and standardised measures of vascular endothelial function were evaluated. Jadad scores, quality scoring parameters for DI and flow-mediated dilation (FMD) methodology used were ascertained. A total of 3959 randomised subjects, mean age 51 (se 0·21) years (range 9-79 years), were represented in the dataset. The mean Jadad scores did not differ statistically among the DI studies, with the majority of the studies being of good quality. Higher DI quality scores were achieved by studies using the botanical ingredients cocoa and isoflavones than by those using the nutrient ingredients folic acid and n-3 fatty acids. The mean DI quality scores were 4·13 (se 0·34), 5·20 (se 0·47), 6·13 (se 0·41) and 6·00 (se 0·59) for the folic acid, n-3 fatty acid, cocoa and isoflavone intervention studies, respectively (and significantly different). The mean Corretti FMD scores were 7·27 (se 0·56), 7·46 (se 0·79), 6·29 (se 0·61) and 7·11 (se 0·56) for the folic acid, n-3 fatty acid, cocoa and isoflavone intervention studies, respectively (NS). FMD studies failed to adequately describe the equipment used and more than half failed to provide an adequate description of the procedures used for vascular image acquisition and measurement. DI can be utilised for dietary intervention studies; however, the methodology should be clearly reported using the guidelines for assessment for both DI and FMD.


Nutrition Today | 2015

Use of Highly Fortified Products among US Adults.

Rebecca B. Costello; Johanna T. Dwyer; Regan L Bailey; Leila G. Saldanha; Steven 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.


Analytical and Bioanalytical Chemistry | 2007

The caffeine contents of dietary supplements commonly purchased in the US: analysis of 53 products with caffeine-containing ingredients

Karen Andrews; Amy Schweitzer; Cuiwei Zhao; Joanne M. Holden; Janet M. Roseland; Mary Bender Brandt; Johanna T. Dwyer; Mary Frances Picciano; Leila G. Saldanha; Kenneth D. Fisher; Elizabeth A. Yetley; Joseph M. Betz; Larry W. Douglass

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Johanna T. Dwyer

National Institutes of Health

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Karen Andrews

United States Department of Agriculture

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Joseph M. Betz

National Institutes of Health

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Joanne M. Holden

Agricultural Research Service

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Janet M. Roseland

United States Department of Agriculture

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Mary Frances Picciano

National Institutes of Health

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Cuiwei Zhao

United States Department of Agriculture

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Rebecca B. Costello

National Institutes of Health

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Pamela R. Pehrsson

United States Department of Agriculture

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Elizabeth A. Yetley

National Institutes of Health

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