Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents

Associations between the consumption of particular foods and health outcomes may be indicated by observational studies. However, intervention trials that evaluate the health benefits of foods provide the strongest evidence to support dietary recommendations for health. Thus, it is important that these trials are carried out safely, and to high scientific standards. Accepted standards for the reporting of the health benefits of pharmaceutical and other medical interventions have been provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there are no generally accepted standards for trials to evaluate the health benefits of foods. Trials with foods differ from medical trials in issues related to safety, ethics, research governance and practical implementation. Furthermore, these important issues can deter the conduct of both medical and nutrition trials in infants, children and adolescents. This paper provides standards for the planning, design, conduct, statistical analysis and interpretation of human intervention trials to evaluate the health benefits of foods that are based on the CONSORT guidelines, and outlines the key issues that need to be addressed in trials in participants in the paediatric age range.

UNISTEP (University Students Exercise and Physical Activity) Study: A Pilot Study of the Effects of Accumulating 10,000 Steps on Health and Fitness Among University Students.

BACKGROUND: Recent public health initiatives have promoted accumulating 10,000 steps per day. Little previous research has evaluated its effects in young adults. The aim of this study was to determine the effects of taking 10,000 steps per day on fitness and cardiovascular risk factors in sedentary university students. METHODS: Healthy, sedentary students (mean age 21.16 ± SD 6.17) were randomly allocated to take 10,000 steps per day or to a control group who maintained their habitual activity. Members of the 10,000 step group wore a pedometer and reported daily step count in a diary. Outcome measurements (20-meter multistage shuttle run, BMI, and blood pressure) were measured before and after 6 weeks. RESULTS: There were no significant differences between the groups at baseline. After 6 weeks, the 10,000 steps group were taking significantly more steps (8824.1 ± SD 5379.3 vs. 12635.9 ± SD 6851.3; P = .03).No changes were observed in fitness, or BMI (P > .05). Significant reductions in blood pressure (P = .04) in the 10,000 step group. CONCLUSIONS: A daily target of 10,000 steps may be an appropriate intervention in sedentary university students to increase their physical activity levels. The positive health benefits of simple everyday physical activity should be promoted among health professionals.

Vegetarian diets, low-meat diets and health:a review

OBJECTIVE: To review the epidemiological evidence for vegetarian diets, low-meat dietary patterns and their association with health status in adults. DESIGN: Published literature review focusing primarily on prospective studies and meta-analyses examining the association between vegetarian diets and health outcomes. RESULTS: Both vegetarian diets and prudent diets allowing small amounts of red meat are associated with reduced risk of diseases, particularly CHD and type 2 diabetes. There is limited evidence of an association between vegetarian diets and cancer prevention. Evidence linking red meat intake, particularly processed meat, and increased risk of CHD, cancer and type 2 diabetes is convincing and provides indirect support for consumption of a plant-based diet. CONCLUSIONS: The health benefits of vegetarian diets are not unique. Prudent plant-based dietary patterns which also allow small intakes of red meat, fish and dairy products have demonstrated significant improvements in health status as well. At this time an optimal dietary intake for health status is unknown. Plant-based diets contain a host of food and nutrients known to have independent health benefits. While vegetarian diets have not shown any adverse effects on health, restrictive and monotonous vegetarian diets may result in nutrient deficiencies with deleterious effects on health. For this reason, appropriate advice is important to ensure a vegetarian diet is nutritionally adequate especially for vulnerable groups.

Social Dance for Successful Aging:The Practice of Health, Happiness, and Social Inclusion Amongst Senior Citizens

This article presents findings from a qualitative study of social
dancing for successful aging amongst senior citizens in three locales:
in Blackpool (GB), around Belfast (NI), and in Sacramento (US). Social
dancers are found to navigate an intense space in society, one of
wellbeing accompanied by a beneficial sense of youthfulness. Besides
such renewal and self-actualisation, findings also attest to the perceived
social, psychological and health benefits of social dancing amongst senior
citizens. They also articulate three different social dancing practices:
social dance as tea dance (Sacramento), social dance as practice dance
(Blackpool), social dance as motility (Belfast and environs).

Gaining ethical approvals to undertake sexual health research with young people in the UK: Applying a 'Children's Rights Based Approach'

This paper (co-written with Dr Maria Lohan, Dr Carmel Kelly & Professor Laura Lundy) will describe the ethical review process to undertake health research in the UK, and explain an approach that can help researchers deal with ethical and methodological dilemmas in their research. Ethical review is necessary to ensure researchers and participants are protected, yet the requirement to ‘pass’ numerous committees may be challenging particularly for health researchers who work with vulnerable groups and sensitive topics. The inclusion of these groups/topics is crucial if health researchers are to understand health disparities and implement appropriate interventions with health benefits for vulnerable populations. It is proposed that to overcome ethical and methodological challenges and pitfalls, researchers must implement strategies that advocate for, and increase the participation of, vulnerable populations in health research. A ‘children’s rights based approach’ using participatory methodology will be described that draws on the jurisprudence of international law, (United Nations Convention on the Rights of the Child, 1989) and provides a framework that may empower ethics committees to carry out their function confidently. The role of the researcher, framed within the context of doctoral level study, will be reviewed in terms of the investment required and benefits of utilising this approach. It will be argued that adopting this approach with vulnerable groups, not only guarantees their meaningful participation in the research process and permits their voices to be heard, but also offers ethics committees an internationally agreed upon legal framework, ratified by their governing States, from which to fulfil their obligations and resolve their ethical dilemmas. Increasing the representation and participation of vulnerable groups in health research can inform the development of health policy and practice based on ‘insider knowledge’ that better engages with and more adequately reflects their specific needs. This is likely to yield numerous health, social and economic benefits for all of society through the delivery of more equitable, effective and sustainable services.

Making personalised nutrition the easy choice: Creating policies to break down the barriers and reap the benefits

Personalised diets based on people’s existing food choices, and/or phenotypic, and/or genetic information hold potential to improve public dietary-related health. The aim of this analysis, therefore, has been to examine the degree to which factors which determine uptake of personalised nutrition vary between EU countries to better target policies to encourage uptake, and optimise the health benefits of personalised nutrition technology. A questionnaire developed from previous qualitative research was used to survey nationally representative samples from 9 EU countries (N = 9381). Perceived barriers to the uptake of personalised nutrition comprised three factors (data protection; the eating context; and, societal acceptance). Trust in sources of information comprised four factors (commerce and media; practitioners; government; family and, friends). Benefits comprised a single factor. Analysis of Variance (ANOVA) was employed to compare differences in responses between the United Kingdom; Ireland; Portugal; Poland; Norway; the Netherlands; Germany; and, Spain. The results indicated that respondents in Greece, Poland, Ireland, Portugal and Spain, rated the benefits of personalised nutrition highest, suggesting a particular readiness in these countries to adopt personalised nutrition interventions. Greek participants were more likely to perceive the social context of eating as a barrier to adoption of personalised nutrition, implying a need for support in negotiating social situations while on a prescribed diet. Those in Spain, Germany, Portugal and Poland scored highest on perceived barriers related to data protection. Government was more trusted than commerce to deliver and provide information on personalised nutrition overall. This was particularly the case in Ireland, Portugal and Greece, indicating an imperative to build trust, particularly in the ability of commercial service providers to deliver personalised dietary regimes effectively in these countries. These findings, obtained from a nationally representative sample of EU citizens, imply that a parallel, integrated, public-private delivery system would capture the needs of most potential consumers.

Short-term consumption of phytoestrogen-rich foods in humans alters dietary macro- and micronutrient intake

The aim of this study was to determine bow nutrient intake is affected by a short-term phytoestrogen-rich diet. Ten healthy volunteers consumed 100 g soya chunks, 150 g lentils, and 250 g kidney beans daily for 3 days. Urine was collected during the 2 days before, 3 intervention days, and 2 days after the intervention and analyzed for phytoestrogen status. Subjects filled in food diaries throughout the study period. Urinary daidzein, but not equol and enterolactone, levels increased during the 7-day period. There was no change in energy, protein, sugar, or total fat intake, but an increase in carbohydrate, fiber, and starch intake. There was a change in the distribution of fat intake with a fall in saturated fat and cholesterol intake. Iron intake significantly increased, although vitamin B-12 fell significantly. The long-term effects of this diet and the associated health benefits of these changes require further study. (C) 2006 Elsevier Inc. All rights reserved.

Short-term phytoestrogen supplementation alters insulin-like growth factor profile but not lipid or antioxidant status

Phytoestrogens are plant compounds that have been proposed to have a variety of health benefits. The aim of this study was to assess the effects of these compounds on a number of physiological endpoints. Subjects were given a single intake of a phytoestrogen-rich (80 mg total phytoestrogens) supplement containing soy, rye and linseed (Phase 1), followed by a week-long intervention using the same supplement (Phase 2) (80 mg total phytoestrogens daily). A number of biochemical endpoints were assessed including urinary phytoestrogen metabolites, lipids, antioxidant status, DNA damage and insulin-like growth factor-1 (IGF-1) and IGF binding protein-1 (IGFBP-1) and -3 (IGFBP-3). Ten healthy female subjects took part in the study. Excretion of the isoflavones genistein, daidzein and equol in urine increased in both phases of the study. No other endpoint was altered in Phase 1. However, in Phase 2, concentrations of IGF-1 and IGFBP-3 were increased by phytoestrogen supplementation [IGF-1, median (IQ range), baseline 155 (123, 258), postweek 265 (228, 360) ng/ml, P

In vitro isoflavone supplementation reduces hydrogen peroxide-induced DNA damage in sperm

Isoflavones are plant compounds, proposed to have health benefits in a variety of human diseases, including coronary heart disease and endocrine-responsive cancers. Their physiological effects include possible antioxidant activity, therefore suggesting a role for isoflavones in the prevention of male infertility. The aim of this study was to test the antioxidant effects of the isoflavones genistein and equol on sperm DNA integrity, assessed in vitro after hydrogen peroxide-mediated damage, using the cornet assay. Pre-treatment with genistein or equol at doses of 0.01-100 mumol/l significantly protected sperm DNA against oxidative damage. Both ascorbic acid (10-600 mumol/l) and alpha-tocopherol (1-100 mumol/l) also protected. Compared with ascorbic acid and alpha-tocopherol, added at physiological concentrations, genistein was the most potent antioxidant, followed by equol, ascorbic acid, and alpha-tocopherol. Genistein and equol added in combination were more protective than when added singly. Based on these preliminary data, which are similar to those observed previously in lymphocytes, these compounds may have a role to play in antioxidant protection against male infertility.

The effect of increasing fruit and vegetable consumption on overall diet: a systematic review and meta-analysis

Increasing fruit and vegetable (FV) consumption is associated with reduced risk of major diseases. However, it is unclear if health benefits are related to increased micronutrient intake or to improvements in overall diet profile. This review aimed to assess if increasing FV consumption had an impact on diet profile. In the systematic review, twelve studies revealed increases in micronutrient intakes, whilst the meta-analysis confirmed macronutrient findings from the systematic review showing no significant difference between the intervention and control groups in energy (kcals) in seven studies (mean difference = 1 kcals [95% CI = -115, 117]; P = 0.98), significant decreases in total fat (% energy) in 5 studies (Mean difference = -4% [95% CI = -5, -3]; P = <0.00001) and significant increases in fibre in 6 studies (Mean difference = 5.36 grams [95% CI = 4, 7]; P = <0.00001) and total carbohydrate (% energy) in 4 studies (Mean = 4% [95% CI = 2, 5]; P = <0.00001). In conclusion, results indicate that increased FV consumption increases micronutrient, carbohydrate and fibre intakes and possibly reduces fat intake, with no overall effect on energy intake. Therefore health benefits may act through an improvement in overall diet profile alongside increased micronutrient intakes.

Session 4: Getting balanced nutrition messages across Nutrition communication: consumer perceptions and predicting intentions

Health claims on food products, which aim at informing the public about the health benefits of the product, represent one type of nutrition communication; the use of these is regulated by the European Union. This paper provides an overview of the research on health claims, including consumers' perceptions of such claims and their intention to buy products that carry health-related claims. This is followed by a discussion on the results from some recent studies investigating public perceptions and willingness to use products with health claims. In these studies, claims are presented in the form of messages of different lengths, types, framing, with and without qualifying words and symbols. They also investigate how perceptions and intentions are affected by individual needs and product characteristics. Results show that adding health claims to products does increase their perceived healthiness. Claim structure was found to make a difference to perceptions, but its influence depended on the level of relevance, familiarity and individuals' need for information. Further, the type of health benefit proposed and the base product used also affected perceptions of healthiness. The paper concludes that while healthiness perceptions relating to products with health claims may vary between men and women, old and young and between countries, the main factor influencing perceived healthiness and intention to buy a product with health claim is personal relevance.