The Application of N-of-1 clinical trial design in nutrition research
What is N-of-1 in a Clinical Study?
Randomised Controlled Trials (RCT) have been regarded as a primary source of evidence in clinical trials and studies involving pharmaceutical and nutraceutical products. A compilation of meta-analyses from two or more RCTs is considered as the highest source of evidence for safety and efficacy. However, the findings from RCT are highly variable, implying that the effects of the product may differ significantly from one participant to another. Moreover, RCTs in nutrition intervention often present misleading information about the progress.
Check out our blog on the challenges of clinical trials for dietary supplements to know about other issues researchers face while investigating a new product.
To address these challenges, a new study design was developed, which can account for individual patient variations. The N-of-1 trial has been gaining more attention in studies involving personalised intervention. N-of-1 clinical studies are those that are intended to observe one person several times, which helps determine the effectiveness of an intervention for a specific health condition or customise dietary recommendations in the case of a nutritional intervention. N-of-1 also helps to gain an understanding of how an individual reacts to specific nutrients or food products.
Advantages of N-of-1 Clinical trial design
N-of-1 has gained attention in recent years because it helps address the limitations of other types of research designs in nutrition research. The advantages include the following:
- Focus on a single study participant
N-of-1 clinical trial design can be customised to individual levels by adjusting an intervention over a period of time to gauge how a participant responds to different interventions.
- Greater Compliance
Since N-of-1 follows an individualised approach, participants are more likely to retain interest. This results in greater compliance and lower propensities of dropping out, which is an issue in group-based clinical studies.
- More economical
N-of-1 study designs are flexible and can be used to answer several research questions in nutrition research. On the contrary, multiple studies can be combined to determine the effects in a group level if the same experimental design is used. This study design can help researchers save time and resources since the study design requires fewer observations to achieve the same statistical power in designs such as RCT.
Moreover, aggregation of N-of-1 studies helps determine whether the findings are generalisable, provided that a number of N-of-1 studies with the same measures have been conducted.
Applications of N-of-1 clinical trial designs
- Nutrition studies
N-of-1 trial designs can be used to develop customised nutrition per an individual’s health preferences and dietary needs. Researchers can design a diet that minimises adverse events and maximises health benefits by monitoring the individual’s response to dietary changes.
- Managing food sensitivities and allergies
N-of-1 trial design can be used to study and manage food allergies and sensitivities. Researchers can assist people in identifying trigger foods and developing safe dietary programs to avoid harmful reactions.
- Studies involving dietary supplements
N-of-1 trial design can evaluate the efficacy of dietary supplements in achieving certain health goals. An N-of-1 study can help assess whether a specific dietary supplement has the intended effects on an individual’s health markers or symptoms.
- Management of chronic diseases
N-of-1 trial design can help determine whether a particular dietary intervention is beneficial in managing chronic diseases such as diabetes, obesity, cardiovascular diseases and conditions due to altered gut microbiome, such as irritable bowel disease. Researchers can examine how different dietary strategies impact an individual’s symptoms, disease markers and overall well-being.
- Adherence studies
N-of-1 trial designs find their application in adherence studies. N-of-1 trial designs can assess the efficacy of various behavioural approaches for improving dietary adherence. Researchers can discover the features that help people adhere to their dietary plans over time [1].
Conclusion
N-of-1 clinical trial designs are revolutionising nutrition science. With an emphasis on individual research participants, the N-of-1 study design enables a highly personalised and dynamic assessment of the effectiveness of therapies for specific health conditions. N-of-1 trial designs have relevance in personalised nutrition programmes, food sensitivity management, dietary supplement efficacy assessment, and chronic disease management such as diabetes. They also help in adherence studies by finding behavioural approaches that promote long-term dietary adherence. Researchers and practitioners alike are increasingly acknowledging the potential of N-of-1 trial designs, resulting in a new evidence-based customised nutrition and healthcare.
How Food Research Lab(FRL) Global Contract R&D can help
We are a team of scientists who assist in various aspects of clinical trial management. We adhere to the highest quality standards while we help in the planning, implementation, monitoring and reporting of clinical trials. We offer assistance in satiety research studies, glycaemic index testing, preclinical studies, sensory research and adherence studies. We comply with the regulations while we offer clinical trial services, ensuring quality, ethical conduct and efficacy, which is crucial for the safety and efficacy of the products.