Methods
Prediabetes, fasting blood glucose, prediabetes
PREDIABETES, DELHI, PREDIABETES
This study was conducted according to the guidelines laid down in the Declaration of Helsinki and Ethical Guidelines for Biomedical Research for Human Participants as enunciated by the Indian Council of Medical Research, New Delhi, India. All procedures involving human participants were approved by an independent review committee, “Ethics Committee for Human Research.” Written informed consent forms, approved by the ethics committee, were signed by the participants. The study was initiated in January 2018 and was completed in June 2021. The study was registered at clinicaltrials.gov (registration no. NCT04769726, available at A total of 60 participants (27 males and 33 females), aged between 18 and 60 years and confirmed with prediabetes were recruited for the study. In total, we screened 1317 participants, out of which 1171 were screen failures and did not fulfill the inclusion/exclusion criteria. Sixty participants gave their consent for the study and were recruited. Prediabetes was diagnosed on OGTT according to the following criteria: fasting blood glucose 5.6 and 7 mmol/L and 2-h plasma glucose (after ingestion of 75-g anhydrous oral glucose mixed in 200 mL water) 7.8 and 11.1 mmol/L or 2-h plasma glucose 7.8 and 11.1 mmol/L [In the OGTT-based study phase (evaluation on OGTT) after a run-in period of 2 weeks, participants were randomized to the control-treatment sequence or treatment-control sequence and then crossed over after a washout period of 7 days (Fig. 