Optimizing clinical trial design for assessing the efficacy of functional foods.

No abstract is available for this paper.

• Publication year

  2010

• Venue

  Nutrition reviews

• Publication date

  2010-08-01

• Fields of study

  Agricultural and Food Sciences, Medicine

• Identifiers
  DOI 10.1111/j.1753-4887.2010.00308.xPMID 20646226
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Fortification of reduced-fat Cheddar cheese with n-3 fatty acids: effect on off-flavor generation.

  2009cited by this paper
• Plant sterol consumption frequency affects plasma lipid levels and cholesterol kinetics in humans

  2009cited by this paper
• Conjugated linoleic acids: why the discrepancy between animal and human studies?

  2008cited by this paper
• Omega-3s in food emulsions: overview and case studies

  2008cited by this paper
• Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease.

  2008cited by this paper
• Advances in Dietary Enrichment with N-3 Fatty Acids

  2008cited by this paper
• Stability and consumer acceptance of long-chain omega-3 fatty acids (eicosapentaenoic acid, 20:5, n-3 and docosahexaenoic acid, 22:6, n-3) in cream-filled sandwich cookies.

  2007cited by this paper
• Consumer acceptance of an extruded soy-based high-protein breakfast cereal.

  2007cited by this paper
• Nutrition Journal BioMed Central

  2007cited by this paper
• Biomarkers of the intake of dietary polyphenols: strengths, limitations and application in nutrition research

  2007cited by this paper
• Dietary plant sterols supplementation does not alter lipoprotein kinetics in men with the metabolic syndrome.

  2007cited by this paper
• Statistical Methods in Medical Research 2007; 1–38 The Biomarker-Surrogacy Evaluation Schema: a

  2007cited by this paper
• Oxidative stability of fish oil enriched drinking yoghurt

  2007cited by this paper
• Clinical nutrition studies: Maximising opportunities and managing the challenges

  2007cited by this paper
• Biomarkers in the Prevention and Treatment of Atherosclerosis: Need, Validation, and Future

  2007cited by this paper
• Bitterness of Soy Extracts Containing Isoflavones and Saponins

  2006cited by this paper
• Stability and Shelf Life of Bioactive Compounds during Food Processing and Storage: Soy Isoflavones

  2006cited by this paper
• The circadian clock within the heart: potential influence on myocardial gene expression, metabolism, and function.

  2006cited by this paper
• The activity and absorption relationship of cholesterol and phytosterols

  2006cited by this paper
• Clinical Aspects of Human Circadian Rhythms

  2005cited by this paper
• Efficiency of the cross‐over design: an empirical estimation

  2004cited by this paper
• SAS for Linear Models (4th ed.)

  2004cited by this paper
• Plant Sterol-Fortified Orange Juice Effectively Lowers Cholesterol Levels in Mildly Hypercholesterolemic Healthy Individuals

  2004cited by this paper
• Dietary conjugated linoleic acid and body composition.

  2004cited by this paper
• Lipids in Health and Disease

  2004cited by this paper
• Functional Foods: Opportunities & Challenges

  2004cited by this paper
• Biomarkers, Surrogate End Points, and the Acceleration of Drug Development for Cancer Prevention and Treatment

  2004cited by this paper
• Vitamin C in human health and disease is still a mystery ? An overview

  2003cited by this paper
• Phytosterols in low- and nonfat beverages as part of a controlled diet fail to lower plasma lipid levels Published, JLR Papers in Press, May 1, 2003. DOI 10.1194/jlr.M300089-JLR200

  2003cited by this paper
• Biomarkers of fat and fatty acid intake.

  2003cited by this paper
• End points and United States Food and Drug Administration approval of oncology drugs.

  2003cited by this paper
• Clinicians' attitudes to clinical practice guidelines

  2003cited by this paper
• Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels.

  2003cited by this paper
• Novel risk markers and clinical practice.

  2003cited by this paper
• Principles of recruitment and retention in clinical trials.

  2003cited by this paper
• Biomarkers in nutritional epidemiology

  2002cited by this paper
• Managing the resource demands of a large sample size in clinical trials: can you succeed with fewer subjects?

  2002cited by this paper
• SAS for Linear Models

  2002cited by this paper
• The use of surrogate endpoints in clinical trials: focus on clinical trials in cardiovascular diseases

  2001cited by this paper
• Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

  2001cited by this paper
• Dietary factors that affect the bioavailability of carotenoids.

  2000cited by this paper
• Bitter taste, phytonutrients, and the consumer: a review.

  2000cited by this paper
• Plant stanol esters affect serum cholesterol concentrations of hypercholesterolemic men and women in a dose-dependent manner.

  2000cited by this paper
• Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects

  1999cited by this paper
• Overview of Nutritional Epidemiology

  1998cited by this paper
• Short-term administration of tall oil phytosterols improves plasma lipid profiles in subjects with different cholesterol levels.

  1998cited by this paper
• Biochemical Indicators of Dietary Intake

  1998cited by this paper
• Run-in periods in randomized trials: implications for the application of results in clinical practice.

  1998cited by this paper
• Depression as a risk factor for ischaemic heart disease in men: population based case-control study

  1998cited by this paper
• Design criteria for studies examining individual fatty acid effects on cardiovascular disease risk factors: human and animal studies.

  1997cited by this paper
• Epidemiology, Biostatistics and Preventive Medicine

  1996cited by this paper
• Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population.

  1995cited by this paper
• Incorporating soy proteins into baked products for use in clinical studies.

  1995cited by this paper
• Quality criteria in human experimental nutrition research.

  1995cited by this paper
• The use of a run-in to enhance compliance.

  1990cited by this paper
• Surrogate endpoints in clinical trials: cardiovascular diseases.

  1989cited by this paper
• The use of surrogate endpoints in clinical trials (an introduction to a series of four papers)

  1989cited by this paper
• Surrogate endpoints in clinical trials: definition and operational criteria.

  1989cited by this paper
• Designing Clinical Research: An Epidemiologic Approach

  1988cited by this paper
• Statistics at Square One

  1976cited by this paper

• Digestion, Metabolism, and Health Effects of Plant Proteins and Their Food Formulations: A Systematic Scoping Review of Clinical Postprandial Studies and in vitro Methods

  2025cites this paper
• The dichotomy between functional and functionalized foods - A critical characterization of concepts.

  2025cites this paper
• Advances in Cell-based therapies for peripheral arterial disease.

  2025cites this paper
• Editorial Board Members’ Collection Series: Functional Foods

  2025cites this paper
• Research on the Influencing Factors of Peristalsis Amplitude Based on an in Vitro Bionic Rat Stomach Model

  2024cites this paper
• A Human Volunteer Study of Nutraceutical Product ‘Rekindle for Men’

  2024cites this paper
• Oral intake of collagen peptide NS improves hydration, elasticity, desquamation, and wrinkling in human skin: a randomized, double-blinded, placebo-controlled study.

  2023cites this paper
• Designing Nutrition for Health—Incorporating Dietary By-Products into Poultry Feeds to Create Functional Foods with Insights into Health Benefits, Risks, Bioactive Compounds, Food Component Functionality and Safety Regulations

  2023cites this paper
• Gluten-Free and Casein-Free Diet for Children with Autism Spectrum Disorder: a Systematic Review

  2022cites this paper
• The Effects of Spirulina maxima Extract on Memory Improvement in Those with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

  2022cites this paper
• Use of food and food-derived products in the treatment of gastritis: A systematic review

  2022cites this paper
• In-depth multidisciplinary review of the usage, manufacturing, regulations & market of dietary supplements

  2021cites this paper
• Lipid-modifying effects of lean fish and fish-derived protein consumption in humans: a systematic review and meta-analysis of randomized controlled trials.

  2021cites this paper
• Common Bean Baked Snack Consumption Reduces Apolipoprotein B-100 Levels: A Randomized Crossover Trial

  2021cites this paper
• A digital scheme of human trials for the evaluation of functional foods.

  2021cites this paper
• Effects of sesame, canola and sesame-canola oils on body weight and composition in adults with type 2 diabetes mellitus: A randomized triple-blind cross-over clinical trial.

  2021cites this paper
• Resveratrol: A "miracle" drug in neuropsychiatry or a cognitive enhancer for mice only? A systematic review and meta-analysis.

  2020cites this paper
• The Efficacy of Squalene in Cardiovascular Disease Risk-A Systematic Review

  2020cites this paper
• Study Design in Experimental Settings

  2019cites this paper
• Dietary intake data quality in the clinical research setting: Implications of quality improvement

  2019cites this paper
• Roles of Phenolic Compounds in the Reduction of Risk Factors of Cardiovascular Diseases

  2019cites this paper
• Nutrition and Functional Foods: Current Trends and Issues

  2018cites this paper
• Diets Low in Saturated Fat with Different Unsaturated Fatty Acid Profiles Similarly Increase Serum-Mediated Cholesterol Efflux from THP-1 Macrophages in a Population with or at Risk for Metabolic Syndrome: The Canola Oil Multicenter Intervention Trial.

  2018cites this paper
• Einsatz und Nutzen funktioneller Parameter als Endpunkte in klinischen Ernährungsstudien

  2018cites this paper
• Strategize the research investigations: pre-clinical and clinical evaluations

  2017cites this paper
• Health Claims and Methodological Controversy in Nutrition Science

  2017cites this paper
• Grading health claims by weight of evidence would make for a better-informed public.

  2017cites this paper
• Healthier Snacking for Corporate Adults: Impact on Cognitive health, Energy levels and hunger satisfaction

  2017cites this paper
• Chapter 6 – Clinical Trials for Foods and Dietary Supplements

  2017cites this paper
• Similarities and Difference between Clinical Trials for Foods and Drugs

  2017cites this paper
• The effects of consumption of functional foods consisting of high oleic canola oil, docosahexaenoic acid and barley β-glucan on plasma lipids

  2017cites this paper
• High Molecular Weight Barley β-Glucan Alters Gut Microbiota Toward Reduced Cardiovascular Disease Risk

  2016cites this paper
• Health Risks and Adverse Reactions to Functional Foods

  2016cites this paper
• Actividad inmunomoduladora del jugo de naranja (Citrus sinensis) var. Valencia sobre la proliferación de Linfocitos B

  2016cites this paper
• Effects of canola and high‐oleic‐acid canola oils on abdominal fat mass in individuals with central obesity

  2016cites this paper
• Guidance for the design and implementation of human dietary intervention studies for health claim submissions

  2016cites this paper
• Assessment of complementary feeding of Canadian infants

  2015cites this paper
• Clinical Trial Barriers in Functional Foods and Nutrition

  2014cites this paper
• Diet and metabolic syndrome: an overview.

  2014cites this paper
• Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents.

  2013cites this paper
• A healthier approach to clinical trials evaluating resveratrol for primary prevention of age-related diseases in healthy populations

  2013cites this paper
• Consumption of low-fat dairy foods for 6 months improves insulin resistance without adversely affecting lipids or bodyweight in healthy adults: a randomized free-living cross-over study

  2013cites this paper
• Design considerations on the proof of efficacy of functional foods

  2012cites this paper
• Effect of high-oleic canola and flaxseed oils on energy expenditure and body composition in hypercholesterolemic subjects.

  2012cites this paper
• Documentation of Functional and Clinical Effects of Infant Nutrition: Setting the Scene for COMMENT

  2012cites this paper
• Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods

  2011cites this paper
• On the Proof of E¢ cacy of Functional Foods: Design Considerations

  2011cites this paper