Kidney DiseasesRenactivityNCT06912425
Effects of an Exercise and Diet Program on Biochemistry and Body Composition in Patients With CKD in G1 and G2 Stages
A study testing Health prevention. in people with Kidney Diseases and Diet, Healthy, run by University of Guadalajara at 1 site in Mexico.
Trial summary
How Exercise, a Controlled Diet and Education Improve the Health of People with Early-Stage Renal Failure: A Study at Ciudad Guzmán Hospital Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Diseases, Diet, Healthy, Dietary Habits
- What is being tested?
- Health prevention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2024to 28 Jan 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of CKD by the physician in G1 and G2
- Who meet the requirements of normal or decreased filtration rate according to:
- G1: ≥ 90 or G2: 60-89 mL/ min/ 1.73m2
- Alterations in the urinary sediment (cellular cylinders of any type, dysmorphic erythrocytes).
- Confirmation of damage by renal ultrasound (Decreased renal size, thinning of the renal cortex, increased echogenicity of the parenchyma, poor differentiation between the renal cortex and sinus, renal cysts suggestive of cortical or medullary changes).
- Men and women between 18 and 65 years old
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- Control of baseline pathologies (glycosylated hemoglobin less than 9%, blood pressure no higher than 140/90mmHg).
- Patients who agree to participate in the study and sign the informed consent form.
- Patients who have no limitations to perform the exercises.
- If participants have diagnosed diabetes or hypertension, who are on medication and under regular internal medicine or nephrology treatment.
- Male and female patients, including those who are illiterate but can be accompanied in the initial sessions to sign the informed consent form.
- All participants, even those who do not have a mobile device, will be provided with an exercise and nutrition guide so that they do not have any limitations when carrying out the activities.
Who cannot join
- Stages 3, 4 and 5
- Children under 18 years of age
- Patients who, due to their place of origin, find it difficult to travel to the sessions.
- Diabetes Mellitus in uncontrolled (Glycated Hemoglobin >9 %)
- Those who have lost their sight
- Presence of uremic alterations such as uremic encephalopathy.
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- Who present unstable blood pressure with blood pressure levels above 140/90mmHg, patients showing sustained blood pressure elevations above 140/90 will be discontinued from the study.
- Peripheral vascular disease of all types (Peripheral Arterial Disease (PAD), Deep Vein Thrombosis (DVT), Chronic Venous Disease (CVD), Abdominal Aortic Aneurysm (AAA), Buerger's Phenomenon (Thromboangiitis Obliterans), Kawasaki Disease).
- Failure to sign the informed consent form
- Elimination Criteria:
- Injury, discomfort that makes reincorporation impossible.
- Patients who have decided to abandon the study
- Patients who do not attend 2 of the face-to-face sessions, those who do not attend two of their sessions will be taken into consideration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Exercise Program and a Protein Controlled Diet Using an Educational Intervention on Biochemical Parameters, Muscle Strength and Body Composition in Patients With Stage G1 and G2 CKD
How Exercise, a Controlled Diet and Education Improve the Health of People with Early-Stage Renal Failure: A Study at Ciudad Guzmán Hospital
Read the detailed description
Chronic kidney disease has a high mortality rate per year, which has led to the search for different intervention strategies to improve adherence to treatment and the promotion of healthy behaviors such as diet and exercise. The latter has been little explored in early stages (G1 and G2) even though its implementation can have an impact on the biochemical parameters of patients and delay their progression. Exercise represents a non-pharmacological, non-invasive, and cost-effective method in health promotion, as it can reduce biomarkers of inflammation such as C-reactive protein, interleukin-6, tumor necrosis factor-α, among others. Despite this, statistics show that 27% of adults in the world do not do the 150 minutes of exercise per week recommended by the World Health Organization (WHO). Regarding medical indications for exercise, there is a prevailing resistance in the medical community regarding its recommendation, given that proteinuria and/or changes in blood pressure linked to this activity are considered to have an impact on renal function. Existing exercise recommendations and proposals are focused on patients on peritoneal dialysis or hemodialysis. One of the most widespread in this patient population are the recommendations made by the WHO for older people with chronic conditions, and more specifically, there are the kidney disease: Improving Global Outcomes (KDIGO) guidelines, however, both give general recommendations, and it has been pointed out as a point of opportunity to explore exercise in this population. The published interventions are limited and do not include biochemical parameters in most of them, nor the physical aptitudes of the patients when performing exercise. On the other hand, it has been identified that the reduction of complications in these patients is associated with healthy behaviors, such as exercise, greater adherence to diet and pharmacological treatment. Several structural barriers have been detected, such as ideological barriers, beliefs, access to treatments, among others, which influence patients' lack of adherence to the plans. Considering the above, the aim of the present research will be to analyze the effects of an exercise program and a protein-controlled diet using an educational intervention on biochemical parameters, muscle strength and body composition in patients with chronic kidney disease in stage G1 and G2. The intervention will be for 3 months and will have two groups: one will follow an exercise program designed for each participant; the second group will follow the exercise recommendation proposed by the KDIGO 2022 guidelines. Both groups will have a personalized dietary plan, educational sessions, body composition and muscle strength assessment monthly. Biochemical parameters such as: creatinine, cystatin C, glucose, urea, urinary sediment, among others, will be evaluated at the beginning and at the end of the intervention to compare changes. Regarding adherence to both the exercise program and the diet, we will seek to reduce the patients' structural barriers by means of educational sessions based on the health belief model (HBM). Topics such as: knowledge of the disease, culinary techniques, barriers that prevent adherence to treatment, among others, will be taught. This project is expected to generate novel knowledge regarding the impact of an educational intervention combined with exercise in patients with chronic kidney disease in early stages. This information may be relevant to guide recommendations in clinical practice guidelines, in addition to promoting the adoption of healthy behaviors such as structured exercise.
- Conditions
- Kidney Diseases, Diet, Healthy, Dietary Habits, Exercise, Kidney Disease, Educational
- Being tested
- Health prevention.
- Keywords
- health belief model, kidney chronic disease, exercise, diet
- Medical subject headings
- Kidney Diseases, Feeding Behavior, Motor Activity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health prevention.Behavioural
Unlike other projects, this study focuses on an underexplored area in exercise and kidney disease research. Typically, exercise recommendations are directed toward individuals undergoing hemodialysis or peritoneal dialysis. However, in the early stages of the disease, when the kidneys begin to show alterations, there is no established safe training protocol as a preventive measure. This clinical trial will fill that gap by providing references for an exercise program specifically designed for individuals in the early stages of kidney disease. The main objective will be to compare two different exercise strategies to determine potential benefits for renal health.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Intervention Group | Experimental | This group will be assigned a personalized exercise program designed by the researchers, specialists in kidney disease training. Participants will be assigned to the supervised exercise intervention through a randomization process, ensuring a homogeneous sample Receives: Behavioral: Health prevention. |
| Exercise Based on KDIGO Recommendations | Experimental | To this group will be assigned KDIGO exercise.
This group will be assigned exercise based on KDIGO recommendations. They will be provided with an exercise template according to KDIGO guidelines, without further exercise planning. Additionally, they will receive a protein-controlled diet along with an educational intervention. Receives: Behavioral: Health prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total cholesterol
Total cholesterol: A decrease in values is expected, taking as reference a normal range of <200 mg/dL. This will indicate a better outcome of the intervention. A change obtained from week 1 to week 12 is expected.
Measured: changes from baseline to week 12
Changes in HDL cholesterol
HDL cholesterol: An increase in its values is expected, with a normal range of >40 mg/dL. The increase will mean better cardiovascular outcomes. Change is expected from week 1 to week 12.
Measured: Changes from baseline measurement to week 12
LDL cholesterol changes
LDL cholesterol: A reduction in its levels is expected, considering a reference value <100 mg/dL. The decrease will mean better cardiovascular outcomes. Evaluation from week 1 to week 12.
Measured: Changes from basal levels up to week 12
Changes in triglycerides levels
Triglycerides: a decrease in values is expected, with a reference range <150 mg/dL. The decrease will mean better cardiovascular outcomes
Measured: Changes from baseline measurement to week 12
Changes in albumin level
Albumin: An increase in its values is anticipated, with a normal range of 3.5-5 g/dL. Its increase will be considered an adequate nutritional parameter and a decrease of inflammatory marker. Evaluation from week 1 to week 12.
Measured: Changes from baseline levels to week 12
Changes in vitamin D levels
Vitamina D (25-hidroxivitamina D o 25(OH)D): Se espera un aumento de los valores, tomando como referencia un rango de 30-50 ng/mL. Evaluación de la semana 1 a la semana 12.
Measured: Changes from baseline levels at week 12
Changes in insulin levels
Insulin: Changes in its values will be analyzed, considering a reference range of 2-25 U/mL. Its increase will be considered a favorable result. Evaluation from week 1 to week 12.
Measured: Changes from baseline to week 12
Changes in Creatina fosfoquinasa (CK total)
Creatine Phosphokinase (Total CK): Values are expected to be maintained or increased as a result of adaptation to exercise, with a reference range of 26-192 U/L. Evaluation from week 1 to week 12.
Measured: Changes from baseline to week 12
Changes in the quality of life questionnaire KDQOL-SF
Kidney Disease Quality of Life: Improvements are expected in the questionnaire score, ranging from 0 (lowest quality of life) to 100 (highest quality of life). Assessment from week 1 to week 12.
Measured: Changes in initial (week 1) and final responses (week 12)
Changes in the answers to the questionnaire "Knowledge of the disease".
Questionnaire "Knowledge of the disease": The changes in the correct answers to the 13 items will be analyzed by means of a score based on the Likert scale. Evaluation from week 1 to week 12.
Measured: changes in initial (week 1) and final responses (week 12)
Changes in the answers to the questionnaire - Opinion on the disease
Opinión sobre la enfermedad: Se evaluarán los cambios en la percepción de los participantes sobre su enfermedad, determinando su grado de acuerdo o desacuerdo con diferentes afirmaciones.
Measured: changes in initial (week 1) and final responses (week 12)
Adherence in exercise frequency
Exercise frequency: It will be measured by self-reporting, recording the number of weekly sessions and the duration of each one. A greater number of sessions will be considered a better indicator of results. Evaluation from week 1 to week 12.
Measured: initial changes (week 1) and final changes (week 12)
Changes in grip strength
Grasping grip strength (dynamometer): An increase in dominant hand grip strength, expressed in kilograms, is expected. Ideal values are >25 kg, but in this population improvement over baseline measurement will be considered. Assessment from week 1 to week 12.
Measured: changes from the baseline measurement (week 1) to the final week (week 12)
Secondary outcomes (5)
Changes in fat mass
Reduction of fat mass: It will be evaluated by electrical bioimpedance (InBody®), comparing the baseline measurement with the final measurement at week 12. A healthy body fat percentage will be taken as a reference point: ≤25% in women and ≤15% in men.
Measured: Comparative changes from baseline (week 1) to final measurement (week 12)
Muscle mass changes
Increase in muscle mass: It will be analyzed through electrical bioimpedance (InBody®), considering an increase in relation to healthy reference values: ≥35% in men and ≥25% in women. Initial and final values (week 12) will be compared.
Measured: Comparative changes from baseline (week 1) to final measurement (week 12)
Changes in body mass index
Body Mass Index (BMI): BMI changes in overweight patients will be evaluated, taking a healthy range of 20-25 kg/m² as a reference.
Measured: Comparative changes from baseline (week 1) to final measurement (week 12)
Changes in the responses to the questionnaire "frequency of food consumption for the Mexican population"
Increase in fruit and vegetable foods and decrease in processed foods, evaluated with the food consumption frequency questionnaire for the Mexican population.
Measured: changes in responses to the questionnaire "food consumption frequency for the mexican population" comparing initial (week 1) and final (week 12) responses
Changes in visceral fat
Changes in visceral fat measured from week 1 to week 12 by InBody bioimpedance scale.
Measured: Changes from baseline measurement (week 1) to final measurement (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Oct 2024
- Primary completion20 Jun 2025
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies 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
- Parallel groups
- Model description
- Humans with CKD in stages 1 and 2
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Patricia Zepeda Salvador, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912425
- Sponsor's protocol ID
- 97/HRCG-JAL/2023
- Other IDs
- AGAF2024/2
- Acronym
- Renactivity
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Body composition, biochemical parameters, muscle strength and food consumption frequency results.
Publications
Ash S, Campbell KL, Bogard J, Millichamp A. Nutrition prescription to achieve positive outcomes in chronic kidney disease: a systematic review. Nutrients. 2014 Jan 22;6(1):416-51. doi: 10.3390/nu6010416.
PubMed 24451311
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Program and a Protein Controlled Diet Using an Educational Intervention on Biochemical Parameters, Muscle Strength and Body Composition in Patients With Stage G1 and G2 CKD
- ClinicalTrials.gov ID
- NCT06912425
- Acronym / sponsor ID
- Renactivity / 97/HRCG-JAL/2023
- Conditions
- Kidney Diseases, Diet, Healthy, Dietary Habits, Exercise, Kidney Disease, Educational
- Keywords
- health belief model, kidney chronic disease, exercise, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 4 Apr 2025 (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.
How Exercise, a Controlled Diet and Education Improve the Health of People with Early-Stage Renal Failure: A Study at Ciudad Guzmán Hospital
Detailed description
Chronic kidney disease has a high mortality rate per year, which has led to the search for different intervention strategies to improve adherence to treatment and the promotion of healthy behaviors such as diet and exercise. The latter has been little explored in early stages (G1 and G2) even though its implementation can have an impact on the biochemical parameters of patients and delay their progression. Exercise represents a non-pharmacological, non-invasive, and cost-effective method in health promotion, as it can reduce biomarkers of inflammation such as C-reactive protein, interleukin-6, tumor necrosis factor-α, among others. Despite this, statistics show that 27% of adults in the world do not do the 150 minutes of exercise per week recommended by the World Health Organization (WHO). Regarding medical indications for exercise, there is a prevailing resistance in the medical community regarding its recommendation, given that proteinuria and/or changes in blood pressure linked to this activity are considered to have an impact on renal function. Existing exercise recommendations and proposals are focused on patients on peritoneal dialysis or hemodialysis. One of the most widespread in this patient population are the recommendations made by the WHO for older people with chronic conditions, and more specifically, there are the kidney disease: Improving Global Outcomes (KDIGO) guidelines, however, both give general recommendations, and it has been pointed out as a point of opportunity to explore exercise in this population. The published interventions are limited and do not include biochemical parameters in most of them, nor the physical aptitudes of the patients when performing exercise. On the other hand, it has been identified that the reduction of complications in these patients is associated with healthy behaviors, such as exercise, greater adherence to diet and pharmacological treatment. Several structural barriers have been detected, such as ideological barriers, beliefs, access to treatments, among others, which influence patients' lack of adherence to the plans. Considering the above, the aim of the present research will be to analyze the effects of an exercise program and a protein-controlled diet using an educational intervention on biochemical parameters, muscle strength and body composition in patients with chronic kidney disease in stage G1 and G2. The intervention will be for 3 months and will have two groups: one will follow an exercise program designed for each participant; the second group will follow the exercise recommendation proposed by the KDIGO 2022 guidelines. Both groups will have a personalized dietary plan, educational sessions, body composition and muscle strength assessment monthly. Biochemical parameters such as: creatinine, cystatin C, glucose, urea, urinary sediment, among others, will be evaluated at the beginning and at the end of the intervention to compare changes. Regarding adherence to both the exercise program and the diet, we will seek to reduce the patients' structural barriers by means of educational sessions based on the health belief model (HBM). Topics such as: knowledge of the disease, culinary techniques, barriers that prevent adherence to treatment, among others, will be taught. This project is expected to generate novel knowledge regarding the impact of an educational intervention combined with exercise in patients with chronic kidney disease in early stages. This information may be relevant to guide recommendations in clinical practice guidelines, in addition to promoting the adoption of healthy behaviors such as structured exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Humans with CKD in stages 1 and 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Intervention Group | Experimental | Behavioral: Health prevention.This group will be assigned a personalized exercise program designed by the researchers, specialists in kidney disease training. Participants will be assigned to the supervised exercise intervention through a randomization process, ensuring a homogeneous sample |
| Exercise Based on KDIGO Recommendations | Experimental | Behavioral: Health prevention.To this group will be assigned KDIGO exercise. This group will be assigned exercise based on KDIGO recommendations. They will be provided with an exercise template according to KDIGO guidelines, without further exercise planning. Additionally, they will receive a protein-controlled diet along with an educational intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Established diagnosis of CKD by the physician in G1 and G2
- Who meet the requirements of normal or decreased filtration rate according to:
- G1: ≥ 90 or G2: 60-89 mL/ min/ 1.73m2
- Alterations in the urinary sediment (cellular cylinders of any type, dysmorphic erythrocytes).
- Confirmation of damage by renal ultrasound (Decreased renal size, thinning of the renal cortex, increased echogenicity of the parenchyma, poor differentiation between the renal cortex and sinus, renal cysts suggestive of cortical or medullary changes).
Key exclusion criteria (13 listed)
- Stages 3, 4 and 5
- Children under 18 years of age
- Patients who, due to their place of origin, find it difficult to travel to the sessions.
- Diabetes Mellitus in uncontrolled (Glycated Hemoglobin >9 %)
- Those who have lost their sight
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 |
|---|---|---|
| Health prevention.Unlike other projects, this study focuses on an underexplored area in exercise and kidney disease research. Typically, exercise recommendations are directed toward individuals undergoing hemodialysis or peritoneal dialysis. However, in the early stages of the disease, when the kidneys begin to show alterations, there is no established safe training protocol as a preventive measure. This clinical trial will fill that gap by providing references for an exercise program specifically designed for individuals in the early stages of kidney disease. The main objective will be to compare two different exercise strategies to determine potential benefits for renal health. | Behavioural | Exercise Based on KDIGO Recommendations, Supervised Exercise Intervention Group |
Primary outcome
Changes in total cholesterol
Time frame: changes from baseline to week 12
Total cholesterol: A decrease in values is expected, taking as reference a normal range of <200 mg/dL. This will indicate a better outcome of the intervention. A change obtained from week 1 to week 12 is expected.
Changes in HDL cholesterol
Time frame: Changes from baseline measurement to week 12
HDL cholesterol: An increase in its values is expected, with a normal range of >40 mg/dL. The increase will mean better cardiovascular outcomes. Change is expected from week 1 to week 12.
LDL cholesterol changes
Time frame: Changes from basal levels up to week 12
LDL cholesterol: A reduction in its levels is expected, considering a reference value <100 mg/dL. The decrease will mean better cardiovascular outcomes. Evaluation from week 1 to week 12.
Changes in triglycerides levels
Time frame: Changes from baseline measurement to week 12
Triglycerides: a decrease in values is expected, with a reference range <150 mg/dL. The decrease will mean better cardiovascular outcomes
Changes in albumin level
Time frame: Changes from baseline levels to week 12
Albumin: An increase in its values is anticipated, with a normal range of 3.5-5 g/dL. Its increase will be considered an adequate nutritional parameter and a decrease of inflammatory marker. Evaluation from week 1 to week 12.
Changes in vitamin D levels
Time frame: Changes from baseline levels at week 12
Vitamina D (25-hidroxivitamina D o 25(OH)D): Se espera un aumento de los valores, tomando como referencia un rango de 30-50 ng/mL. Evaluación de la semana 1 a la semana 12.
Changes in insulin levels
Time frame: Changes from baseline to week 12
Insulin: Changes in its values will be analyzed, considering a reference range of 2-25 U/mL. Its increase will be considered a favorable result. Evaluation from week 1 to week 12.
Changes in Creatina fosfoquinasa (CK total)
Time frame: Changes from baseline to week 12
Creatine Phosphokinase (Total CK): Values are expected to be maintained or increased as a result of adaptation to exercise, with a reference range of 26-192 U/L. Evaluation from week 1 to week 12.
Changes in the quality of life questionnaire KDQOL-SF
Time frame: Changes in initial (week 1) and final responses (week 12)
Kidney Disease Quality of Life: Improvements are expected in the questionnaire score, ranging from 0 (lowest quality of life) to 100 (highest quality of life). Assessment from week 1 to week 12.
Changes in the answers to the questionnaire "Knowledge of the disease".
Time frame: changes in initial (week 1) and final responses (week 12)
Questionnaire "Knowledge of the disease": The changes in the correct answers to the 13 items will be analyzed by means of a score based on the Likert scale. Evaluation from week 1 to week 12.
Changes in the answers to the questionnaire - Opinion on the disease
Time frame: changes in initial (week 1) and final responses (week 12)
Opinión sobre la enfermedad: Se evaluarán los cambios en la percepción de los participantes sobre su enfermedad, determinando su grado de acuerdo o desacuerdo con diferentes afirmaciones.
Adherence in exercise frequency
Time frame: initial changes (week 1) and final changes (week 12)
Exercise frequency: It will be measured by self-reporting, recording the number of weekly sessions and the duration of each one. A greater number of sessions will be considered a better indicator of results. Evaluation from week 1 to week 12.
Changes in grip strength
Time frame: changes from the baseline measurement (week 1) to the final week (week 12)
Grasping grip strength (dynamometer): An increase in dominant hand grip strength, expressed in kilograms, is expected. Ideal values are >25 kg, but in this population improvement over baseline measurement will be considered. Assessment from week 1 to week 12.
5 secondary outcomes
Changes in fat mass
Time frame: Comparative changes from baseline (week 1) to final measurement (week 12)
Muscle mass changes
Time frame: Comparative changes from baseline (week 1) to final measurement (week 12)
Changes in body mass index
Time frame: Comparative changes from baseline (week 1) to final measurement (week 12)
Changes in the responses to the questionnaire "frequency of food consumption for the Mexican population"
Time frame: changes in responses to the questionnaire "food consumption frequency for the mexican population" comparing initial (week 1) and final (week 12) responses
Changes in visceral fat
Time frame: Changes from baseline measurement (week 1) to final measurement (week 12)
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 29 Apr 2026.
- Background: PubMed 24451311Ash S, Campbell KL, Bogard J, Millichamp A. Nutrition prescription to achieve positive outcomes in chronic kidney disease: a systematic review. Nutrients. 2014 Jan 22;6(1):416-51. doi: 10.3390/nu6010416.
- Individual participant dataSharing planned: Yes. Body composition, biochemical parameters, muscle strength and food consumption frequency results.
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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 Health prevention. in people with Kidney Diseases and Diet, Healthy, run by University of Guadalajara at 1 site in Mexico.
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 12 inclusion and 13 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 29 Apr 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 Mexico. 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?
Changes in total cholesterol (time frame: changes from baseline to week 12). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06912425, which also lists 1 linked publication.
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 29 Apr 2026.