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Investigating effect of anti-inflammatory, portfolio low carbohydrate, and intermittent fasting on improving pre- diabetes

The effect of anti-inflammatory, portfolio low carbohydrate, and intermittent fasting on cardio- metabolic status and gene expression in subject with pre-diabetes; an open label randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200608047697N2
Enrollment
100
Registered
2024-05-16
Start date
2024-07-22
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre- diabetes.

Interventions

Intervention 1: Intervention group: anti-inflammatory diet- Diet characteristics: 1. Restriction of daily calorie intake (75% of daily energy requirement). 2. Variety with sufficient amounts of fresh

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Age 18-55 years BMI =25 kg/m2 Consent to participate in the study Suffering from pre-diabetes according to ADA criteria (hemoglobin A1c level between 5.7 and 6.4% or FBS level between 100-125 mg/dL)

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Suffering from diseases such as autoimmune diseases, thyroid and unstable cardiovascular diseases, diabetes, severe depression (due to the inability to answer questions), mental and psychological diseases Medication use related to the above conditions

Design outcomes

Primary

MeasureTime frame
Improving glycemic indices and related gene expression including insulin Receptor (INSR), transcription factor 7 like 2 (TCF7L2), PPARG Co-activator 1- a (PGC1-a). Timepoint: All measurements will be done at the beginning of the study (before the intervention) and at the end of the study (after the intervention). Method of measurement: Glycemic indices including insulin level, blood sugar, hemoglobin A1c will be evaluated in the central laboratory of the University of Medical Sciences. The expression of the mentioned genes is determined by Real Time PCR method and specific primers designed with reliable software.

Secondary

MeasureTime frame
Anthropometric indices and body composition. Timepoint: Before the intervention, in the middle of the study (end of week 6), after the intervention. Method of measurement: Anthropometric measurements include height, weight, waist circumference. Height will be measured in a standing position without shoes. Measurement of waist circumference in the narrowest area, the distance between the bottom of the last rib and the top of the pubic bone in exhalation, is done using an inflexible tape measure without bearing any pressure on the person's body with an accuracy of 0.1 cm. Accurate assessment of weight and body composition is done by the body composition analysis device (Jawon Medical Plus model Avis 333) available in the research laboratory of the school of Nutritional Sciences and Food Technology. Body mass index (BMI) will be calculated by dividing weight (kilograms) by the square of height (meters).;Blood pressure. Timepoint: Before the intervention, in the middle of the study (end of week 6), after the intervention. Method of measurement: A digital arm sphygmomanometer will be used to measure people's blood pressure. At least half an hour before, people should not have intense activity, they should not have consumed coffee, tea and cigarettes. For this purpose, the participant will be asked to sit on an armchair for 5 minutes before the measurement. Then we will measure the person's blood pressure from the left arm twice at 15 minutes intervals. Finally, we will record the average blood pressure measured.;C reactive protein. Timepoint: before and after intervention. Method of measurement: It will be evaluated by the central laboratory of Kermanshah University of Medical Sciences.;Lipid profile. Timepoint: before and after intervention. Method of measurement: It will be evaluated by the central laboratory of Kermanshah University of Medical Sciences.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Moradi

Kermanshah University of Medical Sciences

shima.moradi1400@yahoo.com+98 83 3710 2015

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026