Concept Paper on Best Practices for Ethical Conduct of human Intervention Studies for Novel Food/ Ingredients/Processes/ Technology/ Claim Substantiation by ILSI India K-FFIG

The Concept Paper provides information on the following:
1. When Human Intervention Studies Are Required?
There are several reasons for the conducting Human Intervention Studies including the following:
• New ingredient or food coming under Non Specified Food (NSF) category, (Non Specified Foods are food products or ingredients which are not standardized under the Food Safety Regulations) .
• An approved food or ingredient falling under FSMP (Food for Special Medical Purposes) or FSDU (Food for Special Dietary Uses) category to demonstrate the efficacy and safety,
• An approved food or ingredient using a new process or processing aid,
• A traditional food using a novel non-traditional method for purpose of safety and /or efficacy,
• Any novel food or ingredient or process where sufficient preclinical safety data is available and / or where there is evidence of safe human use for 30 years in another regulatory domain.
• Any food or ingredient or nutrient approved by the FSSAI or in the existing standards/ schedules but with intent of generating efficacy data to make a label claim.

2. Protocol For Human Intervention Studies
It is imperative that a Standard Operating Protocol (SOP)/guidelines be laid down for conducting “Human Intervention Studies for Food and Food Ingredients” including the nutrients as such but not limited to vitamins, minerals, amino acids, botanical extracts, herbs, spices, spice oleoresins and bioactive substances. Following components need to be spelt out:
• Study Design
• Procedure for Selection of Participants (Sampling)
• Approval of the Ethics Committee
• Approval of Heads of Participating Institutions
• Registration in the Clinical Trial Registry
• Protocol for Data Management and Analysis

3. The Types Of Human Studies That Can Be Conducted:
• Proof of Concept / Pilot Studies
• Non-Inferiority Study
• Bioequivalence/ Bioavailability Study
• Case Control
• Cross-sectional Studies
• Randomized or Non-Randomized Trials
• Blinded or open Label Trials

4. Important Factors To Be Taken Into Consideration For Conducting Human Intervention Studies Such As:
• Pre Clinical Data
• Personalized Nutrition
• Extension of an Approved Claim for another formulation / Product
• Post Marketing Studies
• Using Published Research Articles as Evidence or Claims
• Other Sources of Evidence for Safety as well as Claims – Such as Systematic Reviews / Meta-Analysis / Cochrane Reviews


The Concept Paper Can Be Downloaded From:

Keywords: Human Intervention Studies, Ensuring Safety, Regulatory Authority, Regulations, CODEX, FSSAI, Cochrane Review, SALSA Framework, Levels of Evidence, Pre-Clinical Data , Nutrient Bioavailability, Ingredients, Food, Clinical Research, Traditional food