High Protein Dietary IntakeNCT06621940
Effect of Proteins on Antioxidant Capacity
A study testing High Protein Diet and Normal Protein Diet in people with High Protein Dietary Intake, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to provide information about the effect of short-term high protein diet (HPD) feeding on early antioxidant response in women. The definition of HPDs cannot be determined exactly. It is defined differently by various scientific authorities. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Protein Dietary Intake
- What is being tested?
- High Protein Diet and Normal Protein Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2024to 25 Sep 2025
- 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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 19-45 years of age,
- Not changing physical activity throughout the study,
- Having a BMI of 18.5-24.9 kg/m2,
- Being healthy
Who cannot join
- Having a BMI of \<18.5 and ≥25 kg/m2,
- Having a chronic disease,
- Smoking and drinking alcohol,
- Using vitamin-mineral supplements and herbal supplements,
- Being pregnant or breastfeeding,
- Having entered menopause,
- Being on any diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Protein Diet on Total Antioxidant Capacity
This study was planned to provide information about the effect of short-term high protein diet (HPD) feeding on early antioxidant response in women. The definition of HPDs cannot be determined exactly. It is defined differently by various scientific authorities. However, protein is targeted to be approximately 30% of total energy in HPD. It has been determined that HPDs increase satiety, thermogenesis, and provide body weight loss and maintenance of loss. In general, there is evidence that HPD provides more body weight loss in a short time compared to low protein diets. It has been emphasized that the effect of high protein diet on weight loss is related to creating satiety, thus decreasing food intake and increasing thermogenesis. However, the physiological, biochemical and molecular events that occur due to HPD feeding have not been fully understood and the results have not been explained. The effects of HPDs have been determined to last from 1 to 6 days to 6 months. The absence of any study in the literature on the short-term and long-term effects of HPD on oxidative events in humans reveals the original value of this study. Therefore, considering that long-term HPD feeding may increase the risk of cardiovascular disease, blood pressure, and blood lipid levels, the effect of short-term HPD feeding on antioxidant capacity will be investigated in order to avoid these side effects. The planned interviews and measurements for this prospective analytical study will be carried out in the Anthropometry laboratory of the Department of Nutrition and Dietetics, Faculty of Health Sciences at Erciyes University, and blood analyses will be carried out in the Betül Ziya Eren Genome and Stem Cell Research Center laboratory and the Erciyes University Gülser and Dr. Mustafa Gündoğdu Comprehensive Service Laboratory. Healthy female individuals will be applied HPD for 10 days and a normal diet for 10 days as a control. As a result of the applied diets, the expected results of the study are that HPD will cause a decrease in body weight and an increase in lean body mass, even for a short time, and that HPD will have an effect on diet-induced inflammation, cause oxidative stress, affect antioxidant capacity and cause changes in the measured parameters.
Read the detailed description
Today, most individuals try various nutritional models/diets to reduce body weight. One of the most popular of these diets is the diets that reduce carbohydrate intake. Western societies generally avoid high carbohydrates and fat intake. For this reason, interest in high protein intake in diets is increasing day by day. Although there is no general consensus on what a high-protein diet is, the high protein diet (HPD) applied for weight loss studies is diets that contain approximately 30% of the energy provided by protein. The World Health Organization (WHO) has defined obesity as an endemic public problem and stated that its prevalence is increasing. With the increase in obesity, individuals try various dietary modifications to achieve weight loss. These include diets with a more regular macro and micronutrient pattern, such as the Mediterranean Diet and the DASH diet, and diets that may cause deficiencies in terms of macro and micronutrients, such as Atkins, South Beach, Zone, and Stillman, which contain high protein. The most important reasons why high-protein diets attract attention are that they cause rapid weight loss and provide satiety. This positive effect of HPDs on weight loss has attracted the attention of dietitians and caused them to increase the protein ratio in diets. Scientific authorities against popular diets; what is really known about popular diets, the scientific nature of the information, whether it is effective in maintaining body weight, if it is effective, its effect on body composition, micronutrient level, metabolic indicators, hunger-satiety, psychological state, chronic disease risk, its effect on leptin and insulin levels, which provide hormone regulation in long-term energy intake and expenditure.
It is known that HPDs provide more effective results in body weight loss compared to low protein diets. It is suggested that this effect occurs as a result of increased thermogenesis, increased satiety and suppressed appetite, and reduced glycemic index and glycemic load due to the replacement of refined carbohydrates with proteins. In addition to this positive effect on weight loss, there are possible short- and long-term side effects of HPD nutrition. Known complications of long-term HPD nutrition include increased cardiovascular disease risk, blood pressure, blood lipids, and kidney dysfunction. Cardiovascular problems in particular are a source of concern because they will counteract the short-term positive effect of HPD on weight loss and increase the burden of cardiovascular disease in the long term. Studies generally focus on HPD and weight loss; there is limited data on the relationship between HPD nutrition and metabolic dysfunction such as endothelial dysfunction, inflammatory markers, antioxidant status, and other chronic diseases. The physiological, biochemical, and molecular events that occur due to high protein diet nutrition have not been fully understood and their results have not been explained.
High protein diets (especially low carbohydrate diets) are thought to have negative effects because they cause a decrease in fruit and vegetable consumption. In those who eat a HPD, especially inadequate vitamin A, C and E in their diets, this will have a negative effect on antioxidant systems and will pave the way for the development of many chronic and metabolic diseases in the long term. Despite the positive effects of HPD applied as a weight loss diet in the short term, it is thought that the oxidative stress and inflammation it will create in the long term will cause an increase in chronic and metabolic diseases as well as comorbidities. This increase in the disease burden will increase health expenditures both individually and socially.
Therefore, this study was planned to provide information about the effect of short-term HPD feeding on early antioxidant response in adult, healthy, normal body mass index female individuals. As a result of the study, it is thought that short-term HPD feeding will cause an increase in oxidative stress, a decrease in antioxidant capacity and an increase in inflammatory biomarkers.
- Conditions
- High Protein Dietary Intake
- Being tested
- High Protein Diet, Normal Protein Diet
- Keywords
- High protein diet, Antioxidant capacity, Oxidative stress, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein DietOther
Individuals will be placed on a high protein diet for 10 days.
Normal Protein DietOther
Individuals will be placed on a normal protein diet for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Fixed-Sequence Dietary Intervention | Experimental | All participants received the same fixed sequence of dietary interventions. Participants first received a high-protein diet for 10 days (40% carbohydrate, 30% protein, and 30% fat), followed by a two-week wash-out period during which they maintained their habitual dietary intake. They subsequently received a normal-protein diet for 10 days (55% carbohydrate, 15% protein, and 30% fat). Participants were instructed not to consume foods or beverages other than those permitted by the study protocol during both intervention periods. The intervention order was not randomized. Receives: Other: High Protein Diet; Other: Normal Protein Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant capacity after high protein diet
After the diet, antioxidant biomarkers [antioxidant status (TAS), total oxidant status (TOS)] will be measured in the blood. Lower values represent a worse outcome.
Measured: Day after diet end
Anthropometric measurements after high protein diet
Anthropometric measurements will be made after the diet. An increase in anthropometric measurements represents a worse result.
Measured: Day after diet end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start25 Sep 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Protein Dietary IntakeStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were assigned to a single fixed intervention sequence. Participants first received a high-protein diet for 10 days, followed by a two-week wash-out period, and subsequently received a normal-protein diet for 10 days. The intervention order was not randomized, and there were no parallel intervention groups.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Onur Canaydın, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621940
- Sponsor's protocol ID
- ERU-BES-AOC-02
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Protein Diet on Total Antioxidant Capacity
- ClinicalTrials.gov ID
- NCT06621940
- Acronym / sponsor ID
- ERU-BES-AOC-02
- Conditions
- High Protein Dietary Intake
- Keywords
- High protein diet, Antioxidant capacity, Oxidative stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 1 Oct 2024 (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.
This study was planned to provide information about the effect of short-term high protein diet (HPD) feeding on early antioxidant response in women. The definition of HPDs cannot be determined exactly. It is defined differently by various scientific authorities. However, protein is targeted to be approximately 30% of total energy in HPD. It has been determined that HPDs increase satiety, thermogenesis, and provide body weight loss and maintenance of loss. In general, there is evidence that HPD provides more body weight loss in a short time compared to low protein diets. It has been emphasized that the effect of high protein diet on weight loss is related to creating satiety, thus decreasing food intake and increasing thermogenesis. However, the physiological, biochemical and molecular events that occur due to HPD feeding have not been fully understood and the results have not been explained. The effects of HPDs have been determined to last from 1 to 6 days to 6 months. The absence of any study in the literature on the short-term and long-term effects of HPD on oxidative events in humans reveals the original value of this study. Therefore, considering that long-term HPD feeding may increase the risk of cardiovascular disease, blood pressure, and blood lipid levels, the effect of short-term HPD feeding on antioxidant capacity will be investigated in order to avoid these side effects. The planned interviews and measurements for this prospective analytical study will be carried out in the Anthropometry laboratory of the Department of Nutrition and Dietetics, Faculty of Health Sciences at Erciyes University, and blood analyses will be carried out in the Betül Ziya Eren Genome and Stem Cell Research Center laboratory and the Erciyes University Gülser and Dr. Mustafa Gündoğdu Comprehensive Service Laboratory. Healthy female individuals will be applied HPD for 10 days and a normal diet for 10 days as a control. As a result of the applied diets, the expected results of the study are that HPD will cause a decrease in body weight and an increase in lean body mass, even for a short time, and that HPD will have an effect on diet-induced inflammation, cause oxidative stress, affect antioxidant capacity and cause changes in the measured parameters.
Detailed description
Today, most individuals try various nutritional models/diets to reduce body weight. One of the most popular of these diets is the diets that reduce carbohydrate intake. Western societies generally avoid high carbohydrates and fat intake. For this reason, interest in high protein intake in diets is increasing day by day. Although there is no general consensus on what a high-protein diet is, the high protein diet (HPD) applied for weight loss studies is diets that contain approximately 30% of the energy provided by protein. The World Health Organization (WHO) has defined obesity as an endemic public problem and stated that its prevalence is increasing. With the increase in obesity, individuals try various dietary modifications to achieve weight loss. These include diets with a more regular macro and micronutrient pattern, such as the Mediterranean Diet and the DASH diet, and diets that may cause deficiencies in terms of macro and micronutrients, such as Atkins, South Beach, Zone, and Stillman, which contain high protein. The most important reasons why high-protein diets attract attention are that they cause rapid weight loss and provide satiety. This positive effect of HPDs on weight loss has attracted the attention of dietitians and caused them to increase the protein ratio in diets. Scientific authorities against popular diets; what is really known about popular diets, the scientific nature of the information, whether it is effective in maintaining body weight, if it is effective, its effect on body composition, micronutrient level, metabolic indicators, hunger-satiety, psychological state, chronic disease risk, its effect on leptin and insulin levels, which provide hormone regulation in long-term energy intake and expenditure.
It is known that HPDs provide more effective results in body weight loss compared to low protein diets. It is suggested that this effect occurs as a result of increased thermogenesis, increased satiety and suppressed appetite, and reduced glycemic index and glycemic load due to the replacement of refined carbohydrates with proteins. In addition to this positive effect on weight loss, there are possible short- and long-term side effects of HPD nutrition. Known complications of long-term HPD nutrition include increased cardiovascular disease risk, blood pressure, blood lipids, and kidney dysfunction. Cardiovascular problems in particular are a source of concern because they will counteract the short-term positive effect of HPD on weight loss and increase the burden of cardiovascular disease in the long term. Studies generally focus on HPD and weight loss; there is limited data on the relationship between HPD nutrition and metabolic dysfunction such as endothelial dysfunction, inflammatory markers, antioxidant status, and other chronic diseases. The physiological, biochemical, and molecular events that occur due to high protein diet nutrition have not been fully understood and their results have not been explained.
High protein diets (especially low carbohydrate diets) are thought to have negative effects because they cause a decrease in fruit and vegetable consumption. In those who eat a HPD, especially inadequate vitamin A, C and E in their diets, this will have a negative effect on antioxidant systems and will pave the way for the development of many chronic and metabolic diseases in the long term. Despite the positive effects of HPD applied as a weight loss diet in the short term, it is thought that the oxidative stress and inflammation it will create in the long term will cause an increase in chronic and metabolic diseases as well as comorbidities. This increase in the disease burden will increase health expenditures both individually and socially.
Therefore, this study was planned to provide information about the effect of short-term HPD feeding on early antioxidant response in adult, healthy, normal body mass index female individuals. As a result of the study, it is thought that short-term HPD feeding will cause an increase in oxidative stress, a decrease in antioxidant capacity and an increase in inflammatory biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were assigned to a single fixed intervention sequence. Participants first received a high-protein diet for 10 days, followed by a two-week wash-out period, and subsequently received a normal-protein diet for 10 days. The intervention order was not randomized, and there were no parallel intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Fixed-Sequence Dietary Intervention | Experimental | Other: High Protein Diet, Other: Normal Protein DietAll participants received the same fixed sequence of dietary interventions. Participants first received a high-protein diet for 10 days (40% carbohydrate, 30% protein, and 30% fat), followed by a two-week wash-out period during which they maintained their habitual dietary intake. They subsequently received a normal-protein diet for 10 days (55% carbohydrate, 15% protein, and 30% fat). Participants were instructed not to consume foods or beverages other than those permitted by the study protocol during both intervention periods. The intervention order was not randomized. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between 19-45 years of age,
- Not changing physical activity throughout the study,
- Having a BMI of 18.5-24.9 kg/m2,
- Being healthy
Key exclusion criteria (7 listed)
- Having a BMI of \<18.5 and ≥25 kg/m2,
- Having a chronic disease,
- Smoking and drinking alcohol,
- Using vitamin-mineral supplements and herbal supplements,
- Being pregnant or breastfeeding,
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 |
|---|---|---|
| High Protein DietIndividuals will be placed on a high protein diet for 10 days. | Other | Fixed-Sequence Dietary Intervention |
| Normal Protein DietIndividuals will be placed on a normal protein diet for 10 days. | Other | Fixed-Sequence Dietary Intervention |
Primary outcome
Antioxidant capacity after high protein diet
Time frame: Day after diet end
After the diet, antioxidant biomarkers [antioxidant status (TAS), total oxidant status (TOS)] will be measured in the blood. Lower values represent a worse outcome.
Anthropometric measurements after high protein diet
Time frame: Day after diet end
Anthropometric measurements will be made after the diet. An increase in anthropometric measurements represents a worse result.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Diet and Normal Protein Diet in people with High Protein Dietary Intake, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 7 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: finished, as of the sponsor's last update on 21 Jul 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant capacity after high protein diet (time frame: Day after diet end). 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 21 Jul 2026.