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

Sponsor
King Faisal University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05811702
Collaborator
(none)
28
1
2
3.4
8.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: A randomized acute controlled trial of twenty-eight healthy overweight or obese women
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
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.
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Body weight (kg) and BMI [12 weeks]

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

  2. percentage of body fat [12 weeks]

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

Secondary Outcome Measures

  1. Total Cholesterol mg/dl [12 weeks]

    Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Cholesterol mg/dl

  2. Triglycerides) mg/dl ( [12 weeks]

    Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Triglycerides) mg/dl (

  3. HDL) mg/dl ( [12 weeks]

    HDL) mg/dl (

  4. LDL) mg/dl ( [12 weeks]

    LDL) mg/dl (

  5. Glucose (mg/dl) [12 weeks]

    Glucose (mg/dl)

  6. Hb Aic (%) [12 weeks]

    Hb Aic (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Randah Alqurashi Riyadh Saudi Arabia

Sponsors and Collaborators

  • King Faisal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Randah Miqbil Alqurashi, Assistant professor, King Faisal University
ClinicalTrials.gov Identifier:
NCT05811702
Other Study ID Numbers:
  • KingFaisalU
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2023