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Assessment of Health Claims Related to Folic Acid in Food Supplements for Pregnant Women According to the European Regulation.

ABSTRACT: Pregnant women are a vulnerable group with increased nutritional requirements. The daily intake of folic acid, a crucial vitamin for embryonic development, must be reinforced through supplementation, as sometimes diets are not well equilibrated. As consumers increasingly rely on food supplements, it is vital to properly inform them about the health benefits provided by supplements' consumption to ensure their safe use. The objective of this work was to assess the compliance level of health claims related to folic acid in food supplements commercialized in Spain according to the European regulation. Authors performed (1) a review of health-related claims approved for folic acid in Europe, (2) a market research of food supplements commercialized in Spain with those claims, and (3) a selection of food supplements for chemical analysis in the lab to assess these claims. The results showed that nine health-related claims are currently approved for folic acid in Europe. The analytical results for folic acid content in the selected samples were consistent with the declared values and within the tolerance ranges established in the European Guidance document. All samples included accurate dosages and met the legal requirements (European Regulations 1924/2006, 432/2012, 1169/2011) for all approved claims for folic acid.

SUBMITTER: Dominguez L

PROVIDER: S-EPMC7998675 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:During pregnancy, the need for certain nutrients increases. This study assessed the prevalence and socio-demographic factors associated with dietary supplement use in a representative sample of pregnant women in Colombia. METHOD:Data for this study were obtained from a cross-sectional, nationally representative survey (ENSIN, 2010). A total of 1856 pregnant women, 13-49 years of age, were recruited. The use of prenatal dietary supplements (Vitamins A, C or E) was treated as a binary outcome (used at some time or never sued during pregnancy when prescribed by a doctor) in multinomial analyses. Sociodemographic data and associated factors were assessed by computer-assisted personal interview technology. RESULTS:Of the sample, 1123 women (68.6%) reported taking prenatal dietary supplements at some stage during their pregnancy. Most users had a high socioeconomic level (79.5%), were in their third trimester of pregnancy (79.5%), were 30-49 years of age (74.0%), and lived in the central region of Colombia (73.8%). The multivariate logistic regression showed that third trimester of pregnancy (OR 6.2;95% CI 4.0 to 9.3), high educational level (OR 2.3; 95% CI 1.5 to 3.4), high socioeconomic level -SISBEN IV or more- (OR 2.0; 95% CI 1.4 to 2.8), residence in the Atlantic region (north) (OR 2.6; 95% CI 1.7 to 3.6), Eastern region (OR 2.0; 95% CI 1.3 to 3.1), central region (OR 2.6; 95% CI 1.7 to 3.9), Pacific region (west) (OR 1.5; 95% CI 1.0 to 2.3), and belonging to the mestizo (others) ethnic group (OR 1.2; 95% CI 1.0 to 2.6), were all associated with a higher probability of dietary supplement intake. CONCLUSION:The prevalence of prenatal dietary supplements in pregnant women in Colombia was found to be substantial. The variables significantly associated with their use were educational level, socioeconomic level, trimester of pregnancy, geographic level and ethnic group. These results indicate the necessity of implementing new health policies that guarantee uniform access to nutritional supplements for all population sectors, especially in countries, such as Colombia, who are currently undergoing a process of nutritional transition.

Project description:BackgroundIn many low- and middle-income countries, the prevalence of energy and nutrient deficiencies is high among pregnant women. Balanced energy-protein (BEP) supplements are a promising strategy to cover nutritional requirements during pregnancy and improve birth outcomes. However, the displacement of nutrient-dense foods by BEP might attenuate the efficacy of supplementation.ObjectiveThis cross-sectional study of participants in a randomized controlled trial evaluated the difference in energy and macro- and micronutrient intakes, food groups, and nutrient adequacy between a control and intervention group receiving either a daily iron-folic acid (IFA) tablet or IFA and BEP supplement during pregnancy, respectively.MethodsWe collected a single multiple-pass 24-h recall from 470 pregnant women from the MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III study that investigates the efficacy of BEP supplementation on birth outcomes and infant growth. Dietary intake (median and IQR) and nutrient adequacy were assessed using individual recipes and preparation methods of mixed dishes for each participant. Linear regression models were fitted to compare energy and nutrient intakes.ResultsDietary energy, and macro- and micronutrient intakes were significantly higher among women in the intervention group when including BEP [2329 kcal/d (1855, 3008 kcal/d) compared with 1942 kcal/d (1575, 2405 kcal/d) in the control group (all P < 0.001)]. The difference in median energy intake (448 kcal/d; 95% CI: 291, 605 kcal/d) was approximately equivalent to a daily dose of the BEP supplement (393 kcal). Nutrient adequacy ratios for both groups were low for all micronutrients (between 0.02 and 0.66), when excluding BEP (except iron and folic acid, due to standard supplemental doses) from analysis. However, nutrient intakes increased to the Estimated Average Requirement for pregnant women when including BEP supplements.ConclusionsBEP supplementation increases energy and macro- and micronutrient intakes among pregnant women and fills nutrient gaps without displacing food intake. This trial was registered at clinicaltrials.gov as NCT03533712 (https://clinicaltrials.gov/ct2/show/NCT03533712).

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Assessment of Health Claims Related to Folic Acid in Food Supplements for Pregnant Women According to the European Regulation.

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