A Prospective, Multi-Center Study to Evaluate the Safety and Efficacy of a Vegan Nutraceutical to Improve Hair Growth and Quality in Females Following a Plant-Based Diet

Hair thinning affects upwards of 50% of women by age 50, impacting their social-emotional wellbeing. It is a condition now thought to be driven by a multi-factorial etiology, including diet and nutrition. Women following vegan, vegetarian, or other plant-based diets have specific needs for nutrients traditionally sourced from animals, which could affect hair health. To support hair growth and quality in women following a plant-based diet, a novel vegan nutraceutical (Nutrafol Women's Vegan Capsules, Nutraceutical Wellness, Inc., New York, NY) was evaluated for its ability to support hair health. The objectives of this 6-month, multi-site, single-blind prospective clinical study was to evaluate the safety and efficacy of the nutraceutical to improve hair growth and quality in women consuming a plant-based diet. The primary endpoint in this study was an increase in terminal hair count at day 180 compared with baseline, as assessed through phototrichogram analysis. Ninety-five subjects completed the study. Daily intake of the nutraceutical resulted in a significant increase in the number of terminal hairs at day 90 (P<0.01) and day 180 (P<0.01). There was also an increase in total hair counts (P<0.01), the terminal-to-vellus ratio (P<0.01), and a decrease in shedding (P<0.01). Global Investigator Ratings revealed improved hair growth (P<0.00001) and overall quality (P<0.00001). In-person hair strength and brittleness assessments significantly improved as well (P<0.01 for both). A significant proportion of subjects reported improved hair quality, appearance, texture, and volume. Hair problems affecting the quality of life of the subjects were also reported as improved. This study demonstrated significant improvements in hair growth and quality in a plant-based population with a vegan nutraceutical. ClinicalTrials.gov Identifier: NCT05332743. J Drugs Dermatol. 2024;23(8):661-668.  doi:10.36849/JDD.8421.

Food allergy - New risks through vegan diet? Overview of new allergen sources and current data on the potential risk of anaphylaxis.

A vegan diet is increasingly en vogue, i.e., a diet based on plants, in which animal products are completely avoided, often for health and environmental reasons. The menu is supplemented with pulses (e.g., soy, lentils, peas), nuts (e.g., cashew, macadamia, almond, pecan, para, walnut) and seeds (e.g., chia, flaxseed) or pseudo-grains (quinoa, buckwheat). Indeed, the product range is expanding to include vegan foods such as milk alternatives (e.g., oat, almond, soy drinks) and cheese or meat substitutes (e.g., soy-based). Food allergies are also on the rise, with an increasing prevalence worldwide. It is worthy of note that the main allergens of anaphylactic reactions to food in adults are predominantly of plant origin, mainly pulses and nuts - the very foods that form the main source of protein in the vegan diet. In this context, allergies to storage proteins (e.g., Gly m 5 and Gly m 6 from soya beans) can lead to severe anaphylactic reactions, while highly processed substitute products containing plant protein isolates (e.g., pea flour) in concentrated form continue to be of particular concern and may therefore be allergologically problematic. In this article, we aim to provide an overview of allergens and emerging allergen sources in vegan foods and highlight the anaphylaxis risk of the vegan diet.

[Role of vegan diets in food allergies-risk of developing food anaphylaxis?] / Bedeutung veganer Ernährung für die Nahrungsmittelanaphylaxie.

We report about a 28-year-old woman with an anaphylactic reaction to falafel. The diagnosis of type 1 allergy to peas was made based on the detailed medical history, the sensitization profile and an oral food challenge. Pea (Pisum sativum) is a legume that is increasing used, for example, as protein flour in vegetarian and vegan food products. In addition to the case report, we discuss the anaphylaxis risk of food used in the vegan diet.

Retinal changes associated with multivitamin deficiency before and after supplementation.

BACKGROUND: Nutritional visual defects are apparently uncommon nowadays in developed nations. Retinal change-related visual defects caused by hypovitaminoses may be underdiagnosed. AIM OF THE STUDY: To investigate the retinal structural and functional changes in a patient with multivitamin deficiency before and during vitamin supplementation. METHODS: A 51-year-old female had been on vegetarian diet as a child, and on restrict vegan diet during the last 2 years, developing severe bilateral deterioration of visual function and polyneuropathy. Blood test revealed low levels of vitamin A, B6 and D. The patient underwent examinations with optical coherence tomography (OCT), computerized visual field examination (VF), electroretinography (ERG), visual evoked potentials (VEP) and neurography before and after vitamin supplementation. RESULTS: Visual acuity (VA) was 20/1000 and VF examination showed central scotoma in both eyes. Color vision was significantly affected. Full-field ERG showed normal rod and cone function, but a clearly reduced central peak was registered in multifocal ERG (mf-ERG), indicating impaired fovea function. VEP showed delayed latency and low amplitude of P100 in both eyes. Neurography showed sensory polyneuropathy. OCT showed significant thinning of macular ganglion cell plus inner plexiform layer (GCIPL) with rapid progression. Retinal nerve fiber layer (RNFL) was preserved and normal, which is in contrast to neuroinflammatory conditions. After 2.5 years of multivitamin supplementation, the visual functions were improved. GCIPL thickness was stable without further deterioration. CONCLUSIONS: Multivitamin deficiency results in progressive thinning of GCIPL with severe visual deterioration. In contrast to neuroinflammation, RNFL is preserved and normal. Stabilized GCIPL during vitamin supplementation was associated with improved visual function. OCT provides a sensitive and objective measure for differential diagnosis, monitoring retinal change and response to therapy.

Comparison of Postsurgical Scars Between Vegan and Omnivore Patients.

BACKGROUND: Postsurgical skin healing can result in different scars types, ranging from a fine line to pathologic scars, in relation to patients' intrinsic and extrinsic factors. Although the role of nutrition in influencing skin healing is known, no previous studies investigated if the vegan diet may affect postsurgical wounds. OBJECTIVE: The aim of this study was to compare surgical scars between omnivore and vegan patients. METHODS AND MATERIALS: This is a prospective observational study. Twenty-one omnivore and 21 vegan patients who underwent surgical excision of a nonmelanoma skin cancer were enrolled. Postsurgical complications and scar quality were evaluated using the modified Scar Cosmesis Assessment and Rating (SCAR) scale. RESULTS: Vegans showed a significantly lower mean serum iron level (p < .001) and vitamin B12 (p < .001). Wound diastasis was more frequent in vegans (p = .008). After 6 months, vegan patients had a higher modified SCAR score than omnivores (p < .001), showing the worst scar spread (p < .001), more frequent atrophic scars (p < .001), and worse overall impression (p < .001). CONCLUSION: This study suggests that a vegan diet may negatively influence the outcome of surgical scars.

Nutritional Status and the Influence of the Vegan Diet on the Gut Microbiota and Human Health.

The human gut microbiota is considered a well-known complex ecosystem composed of distinct microbial populations, playing a significant role in most aspects of human health and wellness. Several factors such as infant transitions, dietary habits, age, consumption of probiotics and prebiotics, use of antibiotics, intestinal comorbidities, and even metabolic diseases may continously alter microbiota diversity and function. The study of vegan diet-microbiota interactions is a rapidly evolving field, since plenty of research has been focused on the potential effects of plant-based dietary patterns on the human gut microbiota. It has been reported that well-planned vegan diets and their associated components affect both the bacterial composition and metabolic pathways of gut microbiota. Certain benefits associated with medical disorders but also limitations (including nutritional deficiencies) have been documented. Although the vegan diet may be inadequate in calorific value, it is rich in dietary fiber, polyphenols, and antioxidant vitamins. The aim of the present study was to provide an update of the existing knowledge on nutritional status of vegan diets and the influence of their food components on the human gut microbiota and health.

Methylmalonic Acid Levels and their Relation with Cobalamin Supplementation in Spanish Vegetarians.

Cobalamin deficiency represents a health issue for vegetarians, especially vegans, if supplements are not consumed. Vitamin B12 serum levels, traditionally used to assess the vitamin B12 status, can be normal under functional deficiency conditions. In this regard, methylmalonic acid (MMA) has proven to be a more specific marker to detect subclinical vitamin B12 deficiency. In this study, we present for the first time the cobalamin status of Spanish vegetarians using both vitamin B12 and MMA markers, and the effects of the plant-based diet and the intake of vitamin B12 supplements. Healthy adults were recruited (n = 103, 52% vegans). Dietary preferences and use of supplements were assessed by questionnaires and serum samples were collected and stored. Vitamin B12 was measured by chemiluminiscence and MMA by liquid chromatography tandem mass spectrometry (LC-MS/MS) using solid phase extraction for sample preparation. Obtained values, median (IQR), were: vitamin B12, 278.9 (160.2) pmol/l and MMA, 140.2 (78.9) nmol/l. No significant differences between lacto-ovo vegetarians and vegans were observed. Considering these two markers, 10% of the participants were mild vitamin B12 deficient. Supplementation (75% of the participants) was associated with higher vitamin B12 (p < 0.001) and lower MMA (p = 0.012). In conclusion, Spanish vegetarians have low risk of vitamin B12 deficiency due to vitamin B12 supplementation and the MMA determination is useful to detect mild deficiency.

Frequency and risk factors of functional gastro-intestinal disorders in a rural Indian population.

BACKGROUND AND AIM: As best estimates on functional gastrointestinal disorders (FGIDs) prevalence are expected from community studies, which are scanty from Asia, we evaluated the prevalence and risk factors of FGIDs in a rural Indian community. METHODS: House-to-house survey was undertaken by trained interviewers using translated-validated Rome III and hospital anxiety and depression questionnaires. RESULT: Among 3426 subjects ≥ 18 years old from 3 villages in Uttar Pradesh, 84% participated, of whom 80% were finally analyzed. Of these 2774 subjects (age 38.4 ± 16.5 years, 1573 [56.7%] male), 2654 [95.7%] were vegetarian and 120 [4.3%] non-vegetarian. Socioeconomic classes were upper (16.7%), upper middle (15.1%), lower middle (22%), upper lower (22.2%), and lower (24%) using Prasad's Classification; 603 (21.7%) had FGIDs (413 [14.9%] dyspepsia, 75 [2.7%] irritable bowel syndrome (IBS) and 115 [4.1%] dyspepsia-IBS overlap), by Rome III criteria. In subjects with dyspepsia, 49/528 (9%) had epigastric pain, 141 (27%) postprandial distress syndromes (EPS, PDS) and 338 (64%) EPS-PDS overlap. IBS was more often diarrhea than constipation-predominant subtype. On univariate analysis, chewing tobacco, aerated drink, tea/coffee, disturbed sleep, vegetarianism, and anxiety parameters and presence of dyspepsia predicting occurrence of IBS were associated with FGIDs. On multivariate analysis, chewing tobacco, aerated soft drink, tea/coffee, vegetarianism, anxiety parameters, and presence of dyspepsia predicting IBS were significant. CONCLUSION: Functional gastrointestinal disorders, particularly dyspepsia-IBS overlap, are common in rural Indian population; the risk factors included chewing tobacco, aerated soft drink, tea/coffee, vegetarian diet, disturbed sleep, anxiety, and dyspepsia predicting occurrence of IBS.

Vegan-vegetarian low-protein supplemented diets in pregnant CKD patients: fifteen years of experience.

BACKGROUND: Pregnancy in women with advanced CKD becoming increasingly common. However, experience with low-protein diets in CKD patients in pregnancy is still limited. Aim of this study is to review the results obtained over the last 15 years with moderately restricted low-protein diets in pregnant CKD women (combining: CKD stages 3-5, proteinuria: nephrotic at any time, or > =1 g/24 at start or referral; nephrotic in previous pregnancy). CKD patients on unrestricted diets were employed for comparison. STUDY PERIOD: January, 2000 to September, 2015: 36 on-diet pregnancies (31 singleton deliveries, 3 twin deliveries, 1 pregnancy termination, 1 miscarriage); 47 controls (42 singleton deliveries, 5 miscarriages). The diet is basically vegan; since occasional milk and yoghurt are allowed, we defined it vegan-vegetarian; protein intake (0.6-0.8 g/Kg/day), keto-acid supplementation, protein-unrestricted meals (1-3/week) are prescribed according to CKD stage and nutritional status. Statistical analysis was performed as implemented on SPSS. RESULTS: Patients and controls were similar (p: ns) at baseline with regard to age (33 vs 33.5), referral week (7 vs 9), kidney function (CKD 3-5: 48.4 % vs 64.3 %); prevalence of hypertension (51.6 % vs 40.5 %) and proteinuria >3 g/24 h (16.1 % vs 12.2 %). There were more diabetic nephropathies in on-diet patients (on diet: 31.0 % vs controls 5.3 %; p 0.007 (Fisher)) while lupus nephropathies were non-significantly higher in controls (on diet: 10.3 % vs controls 23.7 %; p 0.28 (Fisher)). The incidence of preterm delivery was similar (<37 weeks: on-diet singletons 77.4 %; controls: 71.4 %). The incidence of other adverse pregnancy related outcomes was non-significantly lower in on-diet patients (early preterm delivery: on diet: 32.3 % vs controls 35.7 %; birth-weight = <1.500 g: on diet: 9.7 % vs controls 23.8 %). None of the singletons in the on-diet series died, while two perinatal deaths occurred among the controls (p = 0.505). The incidence of small for gestational age (SGA <10th centile) and/or extremely preterm babies (<28th week) was significantly lower in singletons from on-diet mothers than in controls (on diet: 12.9 % vs controls: 33.3 %; p: 0.04 (Fisher)). CONCLUSION: Moderate protein restriction in the context of a vegan-vegetarian supplemented diet is confirmed as a safe option in the management of pregnant CKD patients.

Rationalizing meat consumption. The 4Ns.

Recent theorizing suggests that the 4Ns - that is, the belief that eating meat is natural, normal, necessary, and nice - are common rationalizations people use to defend their choice of eating meat. However, such theorizing has yet to be subjected to empirical testing. Six studies were conducted on the 4Ns. Studies 1a and 1b demonstrated that the 4N classification captures the vast majority (83%-91%) of justifications people naturally offer in defense of eating meat. In Study 2, individuals who endorsed the 4Ns tended also to objectify (dementalize) animals and included fewer animals in their circle of moral concern, and this was true independent of social dominance orientation. Subsequent studies (Studies 3-5) showed that individuals who endorsed the 4Ns tend not to be motivated by ethical concerns when making food choices, are less involved in animal-welfare advocacy, less driven to restrict animal products from their diet, less proud of their animal-product decisions, tend to endorse Speciesist attitudes, tend to consume meat and animal products more frequently, and are highly committed to eating meat. Furthermore, omnivores who strongly endorsed the 4Ns tended to experience less guilt about their animal-product decisions, highlighting the guilt-alleviating function of the 4Ns.

Could there be a slower physiological healing process in vegan individuals?

The article "Comparing Tattoo Removal Responses in Vegan and Omnivore Patients" by Fusano et al. investigates the clinical outcomes of Q-switched laser tattoo removal in vegans and omnivores. The study reveals that vegans required more laser sessions, exhibited poorer clinical responses, and experienced extended healing periods compared to omnivores. When well-planned vegetarian diets offer numerous health benefits. Unfortunately, the study does not assess the diets of the groups, nor does it address factors like hydration levels and prior skincare regimens, limiting the interpretation of results.

Food for the Brain: Is Vegan/Vegetarian Diet the Way to Go for Hepatic Encephalopathy?

High-protein diet is the cornerstone of supportive care for patients living with hepatic encephalopathy. Although any protein source is better than protein restriction, there is uncertainty regarding the benefits of specific protein types. Using a randomized trial, Badal et al. evaluate the effect on ammonia levels and metabolomics from 3 protein sources in burgers made from beef, vegan products, and vegetarian products. The vegan and vegetarian burgers did not raise ammonia and may result in favorable metabolomic profiles.

Mind the B2: Life-Threatening Neonatal Complications of a Strict Vegan Diet during Pregnancy.

An increasing number of women of reproductive age follow vegan diets. Because vegan diets are deficient in a number of essential nutrients, guidelines address the necessity of supplementations such as iron, zinc, and vitamin B12. However, the risk of riboflavin (vitamin B2) deficiency is not properly addressed. We report a case of a male neonate with a life-threatening hypoglycaemia and lactic acidosis due to severe riboflavin deficiency. The mother followed a strict vegan diet with intermittent use of supplements (folic acid, vitamin B12, vitamin D, omega 3). This case highlights the importance of adequate counselling of all pregnant women adhering to vegan diets to ensure sufficient intake of essential nutrients and vitamins, including riboflavin.

[Pellagra: an ancient disease in a modern world]. / Pelagra: una enfermedad antigua en un mundo moderno.

INTRODUCTION: Introduction: pellagra is a systemic disease due to deficiency of vitamin B3 or tryptophan, its precursor. Vitamin B3 is needed for several metabolic processes, cell signaling, and DNA repair. It is characterized by a classic tetrad of dermatitis, diarrhea, dementia, and death. Pellagra is considered rare nowadays; however, due to the popularity of restrictive diets without necessary supplementation such us veganism, there has been an increase in cases in recent years. Clinical case: we report the case of a young strict vegan female patient in which a pellagra diagnosis was made, and early treatment was administered with an excellent outcome. Discussion: the interest of this case lies in the importance of clinical suspicion and directed history taking focused on social and nutritional factors, as adapted for the current times, in order to make the diagnosis of a rare, subdiagnosed disease that is life-threatening if treatment is delayed.

INTRODUCCIÓN: Introducción: la pelagra es una enfermedad sistémica secundaria a la deficiencia de vitamina B3 o de su precursor, el triptófano. La vitamina B3 es necesaria para varios procesos metabólicos, de señalización celular y reparación del ADN. Se caracteriza por la tétrada clásica de dermatitis, diarrea, demencia y muerte. La misma es considerada una enfermedad rara hoy en día; sin embargo, con el auge de las dietas restrictivas sin la adecuada suplementación, como es el caso del veganismo, se ha visto un aumento de los casos en los últimos años. Caso clínico: exponemos el caso de una paciente adulta joven, vegana estricta, a la cual se le realizó el diagnóstico de pelagra y se le instauró un tratamiento de forma precoz, con una excelente evolución. Discusión: el interés del caso radica en la importancia de la sospecha clínica y la anamnesis dirigida a factores sociales y nutricionales, adaptados a la época actual, para poder hacer el diagnóstico de una enfermedad rara e infradiagnosticada que es potencialmente mortal de retrasarse el inicio del tratamiento.