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

Primary Purpose

Overweight and Obesity, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
A randomized acute controlled trial of twenty-eight healthy overweight or obese women
Sponsored by
King Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Randah AlqurashiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High fat Ketogenic Diet (HFKD)

low-fat diet (LFD

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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,
percentage of body fat
Primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of percentage of body fat,

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2023
Last Updated
June 9, 2023
Sponsor
King Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT05811702
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High fat Ketogenic Diet (HFKD)
Arm Type
Experimental
Arm Description
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.
Arm Title
low-fat diet (LFD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
A randomized acute controlled trial of twenty-eight healthy overweight or obese women
Intervention Description
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
Primary Outcome Measure Information:
Title
Body weight (kg) and BMI
Description
primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat,
Time Frame
12 weeks
Title
percentage of body fat
Description
Primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of percentage of body fat,
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total Cholesterol mg/dl
Description
Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Cholesterol mg/dl
Time Frame
12 weeks
Title
Triglycerides) mg/dl (
Description
Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Triglycerides) mg/dl (
Time Frame
12 weeks
Title
HDL) mg/dl (
Description
HDL) mg/dl (
Time Frame
12 weeks
Title
LDL) mg/dl (
Description
LDL) mg/dl (
Time Frame
12 weeks
Title
Glucose (mg/dl)
Description
Glucose (mg/dl)
Time Frame
12 weeks
Title
Hb Aic (%)
Description
Hb Aic (%)
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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%
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randah Alqurashi, PhD
Phone
00966559223608
Email
ralqurashi@kfu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Atheer Alnobi, MSc
Phone
009665059599
Email
randooo-12@hotmail.com
Facility Information:
Facility Name
Randah Alqurashi
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randah Alqurashi, PhD
Phone
00966559223608
Email
ralqurashi@kfu.edu.sa
First Name & Middle Initial & Last Name & Degree
Atheer Alnobi, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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

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