Overweight and ObesityNCT05811702
The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in Women Body Weight
A study of Overweight and Obesity and Healthy, run by King Faisal University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Healthy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Overwight and obese wonen
- aged 18 and 40
- BMI 25 and 34.5 kg m2
- fat parentage above 30% .
Who cannot join
- Man
- women in normal weight or BMI less than 25 and 34.5 kg m2
- Breastfeeding and pregnant women
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Randah Alqurashi
Riyadh
Randah Alqurashi, PhD, 00966559223608, ralqurashi@kfu.edu.sa
Atheer Alnobi, MSc
About this study
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.
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.
- Conditions
- Overweight and Obesity, Healthy
- Being tested
- A randomized acute controlled trial of twenty-eight healthy overweight or obese women
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: A randomized acute controlled trial of twenty-eight healthy overweight or obese women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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,
Measured: 12 weeks
Secondary outcomes (6)
Total Cholesterol mg/dl
Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Cholesterol mg/dl
Measured: 12 weeks
Triglycerides) mg/dl (
Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Triglycerides) mg/dl (
Measured: 12 weeks
HDL) mg/dl (
HDL) mg/dl (
Measured: 12 weeks
LDL) mg/dl (
LDL) mg/dl (
Measured: 12 weeks
Glucose (mg/dl)
Glucose (mg/dl)
Measured: 12 weeks
Hb Aic (%)
Hb Aic (%)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randah Miqbil Alqurashi, King Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811702
- Sponsor's protocol ID
- KingFaisalU
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05811702
- Acronym / sponsor ID
- KingFaisalU
- Conditions
- Overweight and Obesity, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- King Faisal UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat Ketogenic Diet (HFKD) | Experimental | Other: A randomized acute controlled trial of twenty-eight healthy overweight or obese womenA 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. |
| low-fat diet (LFD | Experimental | Other: A randomized acute controlled trial of twenty-eight healthy overweight or obese womenA 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Overwight and obese wonen
- aged 18 and 40
- BMI 25 and 34.5 kg m2
- fat parentage above 30% .
Key exclusion criteria (3 listed)
- Man
- women in normal weight or BMI less than 25 and 34.5 kg m2
- Breastfeeding and pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A randomized acute controlled trial of twenty-eight healthy overweight or obese womenA 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 | Other | High fat Ketogenic Diet (HFKD), low-fat diet (LFD |
Primary outcome
Body weight (kg) and BMI
Time frame: 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,
percentage of body fat
Time frame: 12 weeks
Primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of percentage of body fat,
6 secondary outcomes
Total Cholesterol mg/dl
Time frame: 12 weeks
Triglycerides) mg/dl (
Time frame: 12 weeks
HDL) mg/dl (
Time frame: 12 weeks
LDL) mg/dl (
Time frame: 12 weeks
Glucose (mg/dl)
Time frame: 12 weeks
Hb Aic (%)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Overweight and Obesity and Healthy, run by King Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randah Alqurashi, PhD (00966559223608, ralqurashi@kfu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) and BMI (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.