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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05811702
Other study ID # KingFaisalU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date November 1, 2023

Study information

Verified date June 2023
Source King Faisal University
Contact Randah Alqurashi, PhD
Phone 00966559223608
Email ralqurashi@kfu.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is investigated the effect of high fat Ketogenic Diet (HFKD) in weight reduction compared to the low-fat diet (LFD) among Saudi overweight and obese women. A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks.


Description:

Obesity is associated with an increased risk of high blood pressure and heart muscle damage, which leads to cases that increase the chances of developing cardiovascular diseases, and if weight gain is not controlled, these results lead to obesity is the main cause of cardiovascular disease and causes dyslipidemia, high blood pressure and diabetes. Recently, there have been followed systems and programs food some of which are beneficial for health and some of them are unhealthy systems. The diet is one of the most controversial issues. The aim of this study is investigated the effect of high fat Ketogenic Diet (HFKD) in weight reduction compared to the low-fat diet (LFD) among Saudi overweight and obese women. A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks. Our primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat, The secondary outcomes have evaluated at the percentage of body fat, blood glucose, lipid profile.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Healthy Overwight and obese wonen - aged 18 and 40 - BMI 25 and 34.5 kg m2 - fat parentage above 30% . Exclusion Criteria: - Man - women in normal weight or BMI less than 25 and 34.5 kg m2 - Breastfeeding and pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
A randomized acute controlled trial of twenty-eight healthy overweight or obese women
A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks. Our primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat

Locations

Country Name City State
Saudi Arabia Randah Alqurashi Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight (kg) and BMI primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat, 12 weeks
Primary percentage of body fat Primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of percentage of body fat, 12 weeks
Secondary Total Cholesterol mg/dl Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Cholesterol mg/dl 12 weeks
Secondary Triglycerides) mg/dl ( Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Triglycerides) mg/dl ( 12 weeks
Secondary HDL) mg/dl ( HDL) mg/dl ( 12 weeks
Secondary LDL) mg/dl ( LDL) mg/dl ( 12 weeks
Secondary Glucose (mg/dl) Glucose (mg/dl) 12 weeks
Secondary Hb Aic (%) Hb Aic (%) 12 weeks
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