A Case of Arrowroot Starch Adulteration: Importance of Independent Testing of Dietary Supplements in Clinical Nutrition Research

Abstract Objectives Adulteration of dietary supplements is widespread and can affect the quality and credibility of clinical nutrition research. In this case report, we describe the difficulties encountered with identity testing of one of our dietary supplements – arrowroot starch – chosen as the placebo for our nutrition intervention trial. Methods To test the effect of protein and alkali on skeletal muscle health, we planned a randomized controlled trial using a high protein diet supplement with or without an alkaline salt supplement. The study selected Maranta arundinacea L. (arrowroot) starch as placebo because of its neutral potential renal acid load compared to some other starches. Commercially available samples of arrowroot starch were purchased from three different US distributors. Independent identity testing was conducted by digital microscopy by Alkemist Labs (Garden Grove, CA). Results All three commercially available arrowroot starch samples came with an authentication certificate stating that the starch was derived from the Maranta arundinacea L. plant. On gross examination, the appearance, odor, and consistency of all three samples was similar. On microscopy with digital photo documentation, starch granules from the Maranta arundinacea L. plant range in shape from ovoid, pear-shaped to triangular. The expected size would be 40–75 um and the distinct pattern would have concentric striations and a hilum that resembles a bird or “M”. Surprisingly, we found that only one of the three commercially available arrowroot starch samples was characteristic of Maranta arundinacea L. granules on microscopy. The starch granules from samples from the other two US distributors could not be identified. Conclusions This case study reveals the extensive adulteration of commercially available arrowroot starch in the US. It also highlights the importance of third-party, independent testing of dietary supplements to confirm authentication of the product composition especially for clinical nutrition trials. Funding Sources NIA R01AG055443–03 (Ceglia).

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Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials

Advances in Nutrition ◽

10.1093/advances/nmaa118 ◽

2020 ◽

Cited By ~ 2

Author(s):

Connie M Weaver ◽

Naomi K Fukagawa ◽

DeAnn Liska ◽

Richard D Mattes ◽

Gregory Matuszek ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Human Nutrition ◽

Clinical Nutrition ◽

Nutrition Intervention ◽

Institutional Review Boards ◽

Controlled Trials ◽

Randomized Controlled ◽

Nutrition Research ◽

Human Nutrition Research ◽

Behavior Issues

ABSTRACT Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on human nutrition research teams. Additionally, because eating is essential, ongoing, and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions. Controlled-feeding trials provide an option to gain more experimental control over food consumed, but at a price of less external validity, and may pose human behavior issues that are unrelated to the intervention. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (institutional review boards, data safety and monitoring boards, US FDA); participant safety; standard operating procedures; training of investigators, staff, and students; and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

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Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147510 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7510

Author(s):

Guillermo García Pérez de Sevilla ◽

Olga Barceló Guido ◽

María de la Paz De la Cruz ◽

Ascensión Blanco Fernández ◽

Lidia B. Alejo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Effect Size ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Nutrition Intervention ◽

Sitting Time ◽

Post Intervention ◽

University Employees ◽

Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

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Cooking for Vitality: Pilot Study of an Innovative Culinary Nutrition Intervention for Cancer-Related Fatigue in Cancer Survivors

Nutrients ◽

10.3390/nu12092760 ◽

2020 ◽

Vol 12 (9) ◽

pp. 2760

Author(s):

Cheryl Pritlove ◽

Geremy Capone ◽

Helena Kita ◽

Stephanie Gladman ◽

Manjula Maganti ◽

...

Keyword(s):

Cancer Survivors ◽

Controlled Trial ◽

Qualitative Interviews ◽

Energy Levels ◽

Nutrition Intervention ◽

Management Skills ◽

Cooking Skills ◽

Patients With Cancer ◽

Cancer Related Fatigue ◽

Poor Nutritional Status

(1) Background: Cancer-related fatigue (CRF) is one of the most prevalent and distressing side effects experienced by patients with cancer during and after treatment, and this negatively impacts all aspects of quality of life. An increasing body of evidence supports the role of poor nutritional status in the etiology of CRF and of specific diets in mitigating CRF. We designed a group-based two session culinary nutrition intervention for CRF, Cooking for Vitality (C4V), aimed at increasing understanding of how food choices can impact energy levels and establishing basic food preparation and cooking skills as well as the application of culinary techniques that minimize the effort/energy required to prepare meals. The purpose of this pilot mixed-method study was to evaluate: Feasibility of the experimental methods and intervention; acceptability and perceived helpfulness of intervention; and to obtain a preliminary estimate of the effectiveness of the intervention on fatigue (primary outcome), energy, overall disability, and confidence to manage fatigue (secondary outcomes). (2) Methods: Prospective, single arm, embedded mixed-methods feasibility study of cancer survivors with cancer-related fatigue was conducted. Participants completed measures at baseline (T0), immediately following the intervention (T1), and three months after the last session (T2). Qualitative interviews were conducted at T2. (3) Results: Recruitment (70%) and retention (72%) rates along with qualitative findings support the feasibility of the C4V intervention for cancer survivors living with CRF (program length and frequency, ease of implementation, and program flexibility). Acceptability was also high and participants provided useful feedback for program improvements. Fatigue (FACT-F) scores significantly improved from T0–T1 and T0–T2 (p < 0.001). There was also a significant decrease in disability scores (WHO-DAS 2.0) from T0–T2 (p = 0.006) and an increase in POMS-Vigor (Profile of Mood States) from T0–T1 (p = 0.018) and T0–T2 (p = 0.013). Confidence in managing fatigue improved significantly from T0–T1 and T0–T2 (p < 0.001). (4) Conclusions: The results suggest that the C4V program was acceptable and helpful to patients and may be effective in improving fatigue levels and self-management skills. A randomized controlled trial is required to confirm these findings.

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Fit for public consumption? An exploratory study of the reporting of nutrition research in UK tabloids with regard to its accuracy, and a preliminary investigation of public attitudes towards it

Public Health Nutrition ◽

10.1017/s1368980007001565 ◽

2008 ◽

Vol 11 (11) ◽

pp. 1124-1131 ◽

Cited By ~ 11

Author(s):

Andrea J Basu ◽

Elaine Hogard

Keyword(s):

Focus Groups ◽

Public Attitudes ◽

Preliminary Investigation ◽

Third Party ◽

Teaching Staff ◽

Analysis Tool ◽

Systematic Analysis ◽

Nutrition Research ◽

Public Consumption ◽

Significant Research

AbstractObjectiveTo explore the quality (accuracy, balance, practical context) of tabloid articles reporting on nutrition research, and public attitudes towards it.DesignA qualitative multi-method study consisting of a systematic analysis of tabloid articles and a series of focus groups with members of the public.SettingTabloid newspapers (nationwide). Focus groups were conducted at a UK university.SubjectsAll UK tabloid newspapers were collated for a full calendar month. Members of the local Women’s Institute and non-teaching staff within the University College Chester were recruited as focus group participants.ResultsTwenty-nine tabloid articles were included. A standardised TAT (Tabloid Analysis Tool) was used a total of thirty-nine times (once for each research study cited). Twenty-six failed to accurately report research results, thirty-six failed to mention significant research limitations, and only five quoted a third-party expert source. Two focus groups, each with eight participants, were conducted. Attitudes expressed were largely negative, highlighting elements of confusion and scepticism. Articles were more likely to be disregarded than acted upon, although some value was attached to newspapers providing nutrition information.ConclusionsTabloid reporting on nutrition research is not sufficiently accurate, balanced or contextualised, and public attitudes towards the reporting are not wholly favourable. Guidance for journalists via registered dietitians and a strengthening of present links could serve to utilise this form of mass media more effectively.

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Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial

Contemporary Clinical Trials ◽

10.1016/j.cct.2015.11.018 ◽

2016 ◽

Vol 46 ◽

pp. 92-99 ◽

Cited By ~ 25

Author(s):

Maria A. Kennelly ◽

Kate Ainscough ◽

Karen Lindsay ◽

Eileen Gibney ◽

Mary Mc Carthy ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Study Protocol ◽

Research Study ◽

Controlled Trial ◽

Smart Phone ◽

Randomized Controlled ◽

Nutrition Research

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Abstracts of the 13th Annual AAVN Clinical Nutrition & Research Symposium. June 12, 2013 Seattle, Washington

Journal of Animal Physiology and Animal Nutrition ◽

10.1111/jpn.12148 ◽

2013 ◽

Vol 97 (6) ◽

pp. 1189-1203

Keyword(s):

Clinical Nutrition ◽

Nutrition Research

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Nutritional disturbance in acid–base balance and osteoporosis: a hypothesis that disregards the essential homeostatic role of the kidney

British Journal Of Nutrition ◽

10.1017/s0007114513000962 ◽

2013 ◽

Vol 110 (7) ◽

pp. 1168-1177 ◽

Cited By ~ 27

Author(s):

Jean-Philippe Bonjour

Keyword(s):

Fracture Risk ◽

Bone Mineral ◽

Bone Growth ◽

Kidney Diseases ◽

Buffer System ◽

Acid Base ◽

Alkaline Salt ◽

Nutrition Research ◽

Acid Base Equilibrium

The nutritional acid load hypothesis of osteoporosis is reviewed from its historical origin to most recent studies with particular attention to the essential but overlooked role of the kidney in acid–base homeostasis. This hypothesis posits that foods associated with an increased urinary acid excretion are deleterious for the skeleton, leading to osteoporosis and enhanced fragility fracture risk. Conversely, foods generating neutral or alkaline urine would favour bone growth and Ca balance, prevent bone loss and reduce osteoporotic fracture risk. This theory currently influences nutrition research, dietary recommendations and the marketing of alkaline salt products or medications meant to optimise bone health and prevent osteoporosis. It stemmed from classic investigations in patients suffering from chronic kidney diseases (CKD) conducted in the 1960s. Accordingly, in CKD, bone mineral mobilisation would serve as a buffer system to acid accumulation. This interpretation was later questioned on both theoretical and experimental grounds. Notwithstanding this questionable role of bone mineral in systemic acid–base equilibrium, not only in CKD but even more in the absence of renal impairment, it is postulated that, in healthy individuals, foods, particularly those containing animal protein, would induce ‘latent’ acidosis and result, in the long run, in osteoporosis. Thus, a questionable interpretation of data from patients with CKD and the subsequent extrapolation to healthy subjects converted a hypothesis into nutritional recommendations for the prevention of osteoporosis. In a historical perspective, the present review dissects out speculation from experimental facts and emphasises the essential role of the renal tubule in systemic acid–base and Ca homeostasis.

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