Clinical trial NCT05811702: The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in Women Body Weight
Official title: The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in the Body Weight and Cardiovascular Risk Factors on Overweight and Obese Saudi Women: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Healthy
Lead sponsor: King Faisal University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight (kg) and BMI
timeFrame: 12 weeks
measure: percentage of body fat
timeFrame: 12 weeks
Secondary outcomes:
measure: Total Cholesterol mg/dl
timeFrame: 12 weeks
measure: Triglycerides) mg/dl (
timeFrame: 12 weeks
measure: HDL) mg/dl (
timeFrame: 12 weeks
measure: LDL) mg/dl (
timeFrame: 12 weeks
measure: Glucose (mg/dl)
timeFrame: 12 weeks
measure: Hb Aic (%)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Randah Alqurashi
Study officials:
References: