NCT05811702

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

March 7, 2023

Last Update Submit

June 9, 2023

Conditions

Overweight and ObesityHealthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Total Cholesterol mg/dl

    12 weeks

  • Triglycerides) mg/dl (

    12 weeks

  • HDL) mg/dl (

    12 weeks

  • LDL) mg/dl (

    12 weeks

  • Glucose (mg/dl)

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

High fat Ketogenic Diet (HFKD)

EXPERIMENTAL

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

low-fat diet (LFD

EXPERIMENTAL

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

Interventions

A randomized acute controlled trial of twenty-eight healthy overweight or obese womenOTHER

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

High fat Ketogenic Diet (HFKD)low-fat diet (LFD

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsA 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%
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Overwight and obese wonen
  • aged 18 and 40
  • BMI 25 and 34.5 kg m2
  • fat parentage above 30% .

You may not qualify if:

  • Man
  • women in normal weight or BMI less than 25 and 34.5 kg m2
  • Breastfeeding and pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Randah Alqurashi

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Randah Alqurashi, PhD

CONTACT

00966559223608ralqurashi@kfu.edu.sa

Atheer Alnobi, MSc

CONTACT

009665059599randooo-12@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 7, 2023

First Posted

April 13, 2023

Study Start

July 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)