Determining the effect of quince fruit extract and apple cider vinegar on glycemic indices in adults with prediabetes: A double blind randomized clinical trial

Determining the effect of fruit extract and apple cider vinegar on glycemic indices in adults with prediabetes.

Controlled, parallel-group, double-blind, randomized trial on 108 patients. Block randomization (block size 6, 18 blocks; allocation to intervention/control). Random sequence generated by a third party using Excel's rand function. Intervention and placebo identically packaged and coded. Principal investigator and patients blinded to allocation. Outcomes assessed by an independent third party not involved in treatment. Unblinding after final analysis.

The participants in this study have prediabetes and are selected through a call and referral by the attending physician of Taleghani Hospital Clinic. After explaining the purpose of the study, if desired, patients will refer to the laboratory of the Endocrine Sciences and Research Institute at the specified time. Patients are asked to fast for 12 hours on the day of visiting the clinic.

Inclusion criteria: cooperation, prediabetes, age 20–50, no smoking or alcohol, no specific diet, no weight change in last 3 months, non-pregnant or lactating, BMI 20–30. Exclusion criteria: lifestyle or drug change during trial, unwillingness to consume apple cider vinegar–quince mixture, hypersensitivity to apple cider vinegar, GI disorders (IBS/IBD).

Patients with prediabetes will be randomly divided into 3 groups (2 intervention groups and 1 control group). In the first group, advise to consume one tablespoon of apple cider vinegar with a glass of water during each meal. In second group, advise to consume one tablespoon of fruit juice during each meal . In the third group, the control group will not receive anything.

Blood sugar control

The design of this study is perfumed block randomization, in which the participants are allocated to intervention and control groups using the Block Randomization method in 18 blocks (in 3 groups) with a Block size of 6. In this study, which will be conducted for 12 weeks, patients with prediabetes will be randomly divided into 3 groups (2 intervention groups and 1 control group). In the first group, it is recommended to consume one tablespoon of apple cider vinegar with a glass of water during each meal (breakfast, lunch, and dinner). In the second group, it is recommended to consume one tablespoon of fruit juice during each meal (breakfast, lunch, and dinner). In the third group, the control group receives nothing. In this study, the principal investigator will not be involved in the randomization process.

In this study, blinding will be done for patients and researchers, and a person outside the research team will be selected to evaluate the results. Randomization will be done by a third person. In this way, patients and study researchers are not aware of the type of groups and the double-blind conditions of the study are maintained. Apple cider vinegar and fruit will be packaged and shipped in such a way that the difference between the two cannot be easily identified. At the end of the study, after the results are determined, the labels will be revealed by a third person and the information will be evaluated.

No further information available.