ClinicalTrials.gg
RecruitingNCT05811702Updated Jun 12, 2023

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

An interventional study of A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Overweight and Obesity and Healthy, sponsored by King Faisal University. Recruiting at 1 site in Saudi Arabia. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-12.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by King Faisal University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years 1 month ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Overweight and Obesity
  • Healthy

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 28 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

King Faisal University is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Man
  • women in normal weight or less than 25 and 34.5 kg m2
  • Breastfeeding and pregnant women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
28 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherA 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

06

What researchers measure

Primary outcomes

  1. 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,

    Time frame: 12 weeks

  2. percentage of body fat

    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 outcomes

  1. Total Cholesterol mg/dl

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

    Time frame: 12 weeks

  2. Triglycerides) mg/dl (

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

    Time frame: 12 weeks

  3. HDL) mg/dl (

    HDL) mg/dl (

    Time frame: 12 weeks

  4. LDL) mg/dl (

    LDL) mg/dl (

    Time frame: 12 weeks

  5. Glucose (mg/dl)

    Glucose (mg/dl)

    Time frame: 12 weeks

  6. Hb Aic (%)

    Hb Aic (%)

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Randah Alqurashi
    Riyadh, Saudi Arabia
    Recruiting
    • Randah Alqurashi, PhD · Contactralqurashi@kfu.edu.sa · 00966559223608
    • Atheer Alnobi, MSc · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2023; primary completion for Oct 2023, 3 months later.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 3 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2023
First posted
Apr 13, 2023
StartEst.
Jul 1, 2023
Primary completionEst.
Oct 1, 2023
CompletionEst.
Nov 1, 2023
Last update
Jun 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05811702
Lead sponsor
King Faisal University
Responsible party
Randah Miqbil Alqurashi (Assistant professor, King Faisal University) — Principal investigator
First posted
Apr 13, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Oct 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Jun 12, 2023

Study contacts

Randah Alqurashi, PhD
Contact
ralqurashi@kfu.edu.sa
00966559223608
Atheer Alnobi, MSc
Contact
randooo-12@hotmail.com
009665059599

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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