]>
IRCT20121228011912N9 IRCT 2026-08-07 Mashhad University of Medical Sciences Investigation of the effect of diet and embedding on serum ghrelin levels and body measurements in individuals with overweight and simple obesity Assessment of standard diet and Embedding Therapy on Anthropometric Indices, Ghrelin Levels , and Bioelectrical Impedance Analysis parameters in overweight and simple obesity individuals. 2026-09-23 anticipated 66 Recruiting https://irct.ir/trial/91001 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with block sizes of 4 and 6 will be used. The random allocation sequence will be generated using a valid online tool (Randomization.com). To ensure allocation concealment, sequentially numbered, sealed envelopes will be employed. To prevent selection bias, the standard technique of opaque, sealed, and sequentially numbered envelopes will be applied. The allocation codes generated in the previous step will be written on cards by an individual independent of the research team and outcome assessors. These cards will then be placed inside opaque envelopes. The envelopes will be sealed and numbered sequentially from 1 to 64 according to the order of participant enrollment. After confirming eligibility criteria, finalizing participant enrollment, and obtaining informed consent, the next envelope in the sequence will be opened. Participants will then be assigned to either the intervention group (embedding plus diet) or the control group (diet only), Blinding description: In this study, blinding was performed as single-blinding, meaning that the participants were unaware of their allocation to the study groups, while the assessors and data analysts were aware of the study conditions. Due to the nature of the intervention, complete blinding of all parties involved was not feasible. 3 Over weight & Simple obesity. Intervention 1: Control group: Under standard dietary treatment .Participants in the control group will receive a standard nutritional regimen prescribed by a specialized nutritionist. Based on the participants’ Body Mass Index (BMI), daily caloric intake will be gradually reduced as follows: a 500 kcal reduction for individuals with a BMI between 28 and 29.9, and a 700 kcal reduction for those with a BMI between 30 and 40. Before the intervention, as well as 4 and 16 weeks post-intervention, serum ghrelin levels, waist circumference, body fat and muscle mass, and phase angle will be assessed using Bioelectrical Impedance Analysis (BIA). Intervention 2: Intervention group: Under standard dietary & embedding treatment .In this group, participants will be provided with a customized diet plan under the supervision of a nutritionist. Daily caloric intake will be gradually reduced as follows: a 500 kcal deficit for individuals with a Body Mass Index (BMI) of 28–30, and a 700 kcal deficit for those with a BMI of 30–40. Concurrently with the initiation of the diet, each participant will undergo a single session of PDO thread embedding at twenty specific anatomical points. Serum ghrelin levels, waist circumference, body fat and muscle mass, and phase angle will be measured using Bioelectrical Impedance Analysis (BIA) at three time points: at baseline (pre-intervention), and at 4 and 16 weeks post-intervention. Yes - There is a plan to make this available What will be shared: The statistical details of the data will be mentioned in the published article. When: After finishing the research To whom: All individuals who have access to the published article or those who obtain permission from the Research Vice‑Chancellor of Mashhad University of Medical Sciences. Conditions: With the permission of the principal investigator and the approval of the University Research Council, and solely for informational purposes without any possibility of using or exploiting the data content. Where to obtain: After publication of the article, the data will be available to the corresponding author; before publication, if necessary, they may be provided to the principal investigator upon request by the relevant authorities. How to obtain: By means of Vice research of Mashhad University of Medical Science Comments:
public Dr. Sara Mousavinik
Daneshgah st , Imam Reza hospital
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3841 1538 ---mousaviniks4021@mums.ac.ir Mashhad University of Medical Sciences scientific Dr.Hamidreza Bahrami Taghanaki
Daneshgah st , Imam Reza hospital
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3841 1538 bahramihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) BMI between 28-40 Waist circumference greater than 90 cm in men and 80 cm in women. More than 6 months postpartum. blood pressure less than 140/90 no contraindication for embedding No consumption of weight‑reducing medications. No hepatic/renal disease 18 years 60 years Both history of acupuncture/embedding for weight loss in the past months diabetes presence of febrile disease pregnancy E66.0 Obesity due to excess calories Treatment - Other Treatment - Other Control group: Under standard dietary treatment .Participants in the control group will receive a standard nutritional regimen prescribed by a specialized nutritionist. Based on the participants’ Body Mass Index (BMI), daily caloric intake will be gradually reduced as follows: a 500 kcal reduction for individuals with a BMI between 28 and 29.9, and a 700 kcal reduction for those with a BMI between 30 and 40. Before the intervention, as well as 4 and 16 weeks post-intervention, serum ghrelin levels, waist circumference, body fat and muscle mass, and phase angle will be assessed using Bioelectrical Impedance Analysis (BIA) Intervention group: Under standard dietary & embedding treatment .In this group, participants will be provided with a customized diet plan under the supervision of a nutritionist. Daily caloric intake will be gradually reduced as follows: a 500 kcal deficit for individuals with a Body Mass Index (BMI) of 28–30, and a 700 kcal deficit for those with a BMI of 30–40. Concurrently with the initiation of the diet, each participant will undergo a single session of PDO thread embedding at twenty specific anatomical points. Serum ghrelin levels, waist circumference, body fat and muscle mass, and phase angle will be measured using Bioelectrical Impedance Analysis (BIA) at three time points: at baseline (pre-intervention), and at 4 and 16 weeks post-intervention. Body weight. Timepoint: Before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: Using a weighing scale and a bioimpedance analyzer. Body Mass Index. Timepoint: Before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: Using a bioimpedance analyzer. Weight circumference. Timepoint: Before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: Using a bioimpedance analyzer. Body fat mass. Timepoint: Before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: Using a bioimpedance analyzer. Body muscle mass. Timepoint: Before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: Using a bioimpedance analyzer. Phase angle . Timepoint: Before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: Using a bioimpedance analyzer. Serum Ghrelin level. Timepoint: before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: Using Plasma sample and Ghrelin kit. Quality of life. Timepoint: before intervention , 4 weeks and 16 weeks after intervention. Method of measurement: World Health Organization (WHO) questionnaire. Mashhad University of Medical Sciences Approved 2026-06-17 Ethics committee of Mashhad University of Medical Sciences Daneshgah st , acupuncture clinic , Imam Reza hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)