The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in Women Body Weight

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Overweight and Obesity
• Intervention / Treatment: Other: A randomized acute controlled trial of twenty-eight healthy overweight or obese women

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randah Alqurashi, PhD; Phone Number: 00966559223608; Email: ralqurashi@kfu.edu.sa
• Study Contact Backup: Name: Atheer Alnobi, MSc; Phone Number: 009665059599; Email: randooo-12@hotmail.com

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • Randah Alqurashi
    • Contact: Randah Alqurashi, PhD; Phone Number: 00966559223608; Email: ralqurashi@kfu.edu.sa
    • Sub-Investigator: Atheer Alnobi, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High fat Ketogenic Diet (HFKD); 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 for 12 weeks. The weight will be measured weekly, body fat % and blood samples before and after 12 weeks of following HFKD.	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
Experimental: low-fat diet (LFD; A randomised 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 LFD for 12 weeks. The weight will be measured weekly, body fat % and blood samples before and after 12 weeks of following LFD.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cholesterol mg/dl	Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Cholesterol mg/dl	12 weeks
Triglycerides) mg/dl (	Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Triglycerides) mg/dl (	12 weeks
HDL) mg/dl (	HDL) mg/dl (	12 weeks
LDL) mg/dl (	LDL) mg/dl (	12 weeks
Glucose (mg/dl)	Glucose (mg/dl)	12 weeks
Hb Aic (%)	Hb Aic (%)	12 weeks

Collaborators and Investigators

• Sponsor: King Faisal University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight
• Other Study ID Numbers: KingFaisalU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No