The Application of N-of-1 clinical trial design in nutrition research

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THE APPLICATION OF N-OF-1 CLINICAL TRIAL DESIGN
IN NUTRITION RESEARCH
An Academic presentation by Dr. Nancy Agnes,
Head, Technical Operations, FoodResearchLab Group
www.foodresearchlab.com Email
info_at_foodresearchlab.com
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What is N-of-1 in a Clinical Study?

• Randomised Controlled Trials (RCT) has been
  regarded as a primary source of evidence in
  clinical trials involving pharmaceutical and
  nutraceutical products.
• A compilation of meta-analyses from two or more
  RCTs is considered as the highest source of
  evidence for the 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 with misleading information about the
  progress.

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• 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.

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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 customized to
  individual level, by adjusting an intervention
  over a period of time to gauge how a participant
  responds to different interventions.

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• GREATER COMPLIANCE

• Since N-of-1 follows an individualized 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.

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• 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.

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Applications of N-of-1 clinical trial designs
1.Nutrition studies
N-of-1 trial designs can be used to develop
customised nutrition per an individuals health
preferences and dietary needs.
2.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.

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3.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.

4.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 individuals symptoms,
  disease markers and the overall well-being.

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5.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.

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Conclusion

• 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.

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HOW GUIRES FRL GLOBAL CONTRACT RD 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.

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