ObesityPI21/01677NCT05420311
Personalized or Precision Medicine in the Dietary Approach to Obesity
A study testing MedDiet Arm, KetoDiet Arm and IF Arm in people with Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
The main objective of this project is to apply a precision medicine approach to try to explain the intra-individual variability of the response to different weight loss approaches: a balanced hypocaloric diet in macronutrients (MedDiet), a very low carbohydrate diet (KetoDiet) and an intermittent fasting (IF)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MedDiet Arm, KetoDiet Arm and IF Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 31 Oct 2022to 1 Dec 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged ≥ 18 and <70 years old who were derived to the obesity-management unit of the Endocrinology and Nutrition Unit of the Virgen de la Victoria Hospital (Málaga).
- BMI between 35 and 45 kg/m2.
Who cannot join
- Pregnant or lactating
- Following a prescribed diet for any reason in the past 3 months
- Celiac disease, Crohn's disease or any condition altering nutritional requirements.
- Allergies or food intolerances, as well as antibiotics treatment or usual probiotics intake.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Francisco J Tinahones, MD, PhD, +34 951 932 734, fjtinahones@uma.es
Isabel Moreno-Indias, PhD, +34 951032647, isabel.moreno@ibima.eu
About this study
The main objective of this project is to apply a precision medicine approach to try to explain the intra-individual variability of the response to different weight loss approaches: a balanced hypocaloric diet in macronutrients (MedDiet), a very low carbohydrate diet (KetoDiet) and an intermittent fasting (IF) approach, and try to establish in a personalized manner with the individual variability in genetics, metabolites, intestinal microbiome, and environmental factors the best dietary strategy for weight loss. As secondary objectives the investigators pretend to O1: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in insulin resistance, blood pressure, lipid levels and NASH markers after three different dietary interventions. O2: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in the body composition and the different ratio of free-fat/ fat mass loss after three different dietary interventions. O3: To determine the most effective intervention to increase the loss of fat mass, preserve the free-fat mass and trigger a better metabolic profile. O4: To follow-up changes in gut microbiota and DNA methylation after each of the cross-over dietary interventions. O5: To evaluate the transcriptional response of adipose tissue and elucidate its predictive value for the body-composition changes in patients subjected to the different dietary interventions.
O6: To evaluate the influence of D-ß-hydroxybutyrate as well as other short-chain acyl-CoA precursor metabolites in human adipocytes lipolysis by in vitro experimentation and elucidate the influence of metabolite-sensitive histone modifications in the shaping of adipose transcriptional program and lipolysis sensitivity. O7: To develop a machine learning algorithm based on genetics, epigenetics, intestinal microbiome, and environmental factors for the prediction of the best dietary approach for weight loss in a personalized manner. To try to respond to these objectives, the investigators will apply two models: a randomized cross-over study testing three different dietary weight-loss interventions: MedDiet, KetoDiet, and IF with wash-out periods before each intervention.
Read the detailed description
The main objective of this project is to apply a precision medicine approach to try to explain the intra-individual variability of the response to different weight loss approaches: a balanced hypocaloric diet in macronutrients (MedDiet), a very low carbohydrate diet (KetoDiet) and an intermittent fasting (IF) approach, and try to establish in a personalized manner with the individual variability in genetics, metabolites, intestinal microbiome, and environmental factors the best dietary strategy for weight loss. As secondary objectives the investigators pretend to O1: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in insulin resistance, blood pressure, lipid levels and NASH markers after three different dietary interventions. O2: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in the body composition and the different ratio of free-fat/ fat mass loss after three different dietary interventions. O3: To determine the most effective intervention to increase the loss of fat mass, preserve the free-fat mass and trigger a better metabolic profile. O4: To follow-up changes in gut microbiota and DNA methylation after each of the cross-over dietary interventions. O5: To evaluate the transcriptional response of adipose tissue and elucidate its predictive value for the body-composition changes in patients subjected to the different dietary interventions. O6: To evaluate the influence of D-ß-hydroxybutyrate as well as other short-chain acyl-CoA precursor metabolites in human adipocytes lipolysis by in vitro experimentation and elucidate the influence of metabolite-sensitive histone modifications in the shaping of adipose transcriptional program and lipolysis sensitivity. O7: To develop a machine learning algorithm based on genetics, epigenetics, intestinal microbiome, and environmental factors for the prediction of the best dietary approach for weight loss in a personalized manner. To try to respond to these objectives, the investigators will apply two models: a randomized cross-over study testing three different dietary weight-loss interventions: MedDiet, KetoDiet, and IF with wash-out periods before each intervention in patients with obesity; and a second cellular approach with adipose tissue from the patients as well as with commercial cells.
- Conditions
- Obesity
- Being tested
- MedDiet Arm, KetoDiet Arm, IF Arm
- Keywords
- Precision medicine, nutrigenomics, microbiome, obesity, diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedDiet ArmOther
A balanced hypocaloric diet in macronutrients (MedDiet)
KetoDiet ArmOther
A very low carbohydrate diet (KetoDiet).
IF ArmOther
An intermittent fasting (IF) approach
| Study group | Role | What they receive |
|---|---|---|
| A balanced hypocaloric diet in macronutrients (MedDiet). | Experimental | Mediterranean diet based on olive oil as main fat and regular consumption of vegetables (2 daily rations), fruits (3 daily rations), legumes (3 weekly rations), fish (3 weekly rations), with low consumption of red meat and meat products (less than twice a week), dairy foods (less than once a week) and no sweets, pastries or sugary drinks. Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein distributed in at least 4 meals (breakfast, lunch, afternoon snack and dinner). Receives: Other: MedDiet Arm |
| A very low carbohydrate diet (KetoDiet). | Experimental | Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein Receives: Other: KetoDiet Arm |
| An intermittent fasting (IF) approach. | Experimental | In this diet subjects alternate norm caloric diet during 24 h (according to Harris-Benedict equation) and a diet including only 25% of caloric requirements the following 24 h (this day diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein). Receives: Other: IF Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight after each intervention
Weight in kg
Measured: From baseline to 1 month
Secondary outcomes (13)
Changes in body composition and in the ratio of free-fat / fat mass loss after the three different dietary interventions.
Ratio in %
Measured: From baseline to 1 month
Changes in the degree of insulin resistance.
Measured by the HOMA-IR ratio
Measured: From baseline to 1 month
Changes in the systolic blood pressure
Blood pressure measured in millimeters of mercury
Measured: From baseline to 1 month
Changes in the diastolic blood pressure
Blood pressure measured in millimeters of mercury
Measured: From baseline to 1 month
Changes in lipid profile (triglycerides)
Measured in mg/dl
Measured: From baseline to 1 month
Changes in lipid profile (cholesterol)
Measured in mg/dl
Measured: From baseline to 1 month
Changes in the degree of ketosis
Measured in mmol/l
Measured: From baseline to 1 month
Changes in gut microbiota
Change from baseline in 16S rRNA amplicons after 1 month
Measured: From baseline to 1 month
DNA methylation.
Measured by a Methylation Array of the whole genome interrogating 850000 CpGs.
Measured: From baseline to 1 month
Changes in the punctuation in neurocognitive test - Trailmaking Test (A - B)
Trailmaking Test (A - B) allows evaluating visual search speed, working memory, motor skills, visual-spatial sequencing, sustained attention, divided attention and mental flexibility (time: reduction in seconds)
Measured: From baseline to 1 month
Changes in the punctuation in neurocognitive test - Stroop
Stroop measures selective attention and inhibitory control. (increasing scores)
Measured: From baseline to 1 month
Changes in the punctuation in neurocognitive test - WAISspan
Letters and numbers from the WAISspan for working memory, concentration, auditory sequencing and executive attention. (time: reduction in seconds)
Measured: From baseline to 1 month
Changes in the punctuation in neurocognitive test - UPPS-P
- Trailmaking Test (A - B) allows evaluating visual search speed, working memory, motor skills, visual-spatial sequencing, sustained attention, divided attention and mental flexibility (time: reduction in seconds)
- Stroop: Measures selective attention and inhibitory control. (increasing scores)
- Letters and numbers from the WAISspan for working memory, concentration, auditory sequencing and executive attention. (time: reduction in seconds)
- UPPS-P: Impulse BehaviorScale (Cyders et al. 2007; validated in Spanish by Candido et al, 2012). Self- administered scale that evaluates impulsivity. Scale of items using a 4-point likert scale (min 59 /max 136 points).
Measured: From baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start31 Oct 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized cross-over study testing three different dietary weight-loss interventions
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franscisco J. Tinahones, MD, PhD., Principal investigator, Instituto de Investigacion Biomedica de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420311
- Sponsor's protocol ID
- PI21/01677
- Acronym
- PI21/01677
- Status last verified
- Apr 2022
- First submitted
- 18 May 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized or Precision Medicine in the Dietary Approach to Obesity
- ClinicalTrials.gov ID
- NCT05420311
- Acronym / sponsor ID
- PI21/01677 / PI21/01677
- Conditions
- Obesity
- Keywords
- Precision medicine, nutrigenomics, microbiome, obesity, diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 31 Oct 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Jun 2022 (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 main objective of this project is to apply a precision medicine approach to try to explain the intra-individual variability of the response to different weight loss approaches: a balanced hypocaloric diet in macronutrients (MedDiet), a very low carbohydrate diet (KetoDiet) and an intermittent fasting (IF) approach, and try to establish in a personalized manner with the individual variability in genetics, metabolites, intestinal microbiome, and environmental factors the best dietary strategy for weight loss. As secondary objectives the investigators pretend to O1: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in insulin resistance, blood pressure, lipid levels and NASH markers after three different dietary interventions. O2: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in the body composition and the different ratio of free-fat/ fat mass loss after three different dietary interventions. O3: To determine the most effective intervention to increase the loss of fat mass, preserve the free-fat mass and trigger a better metabolic profile. O4: To follow-up changes in gut microbiota and DNA methylation after each of the cross-over dietary interventions. O5: To evaluate the transcriptional response of adipose tissue and elucidate its predictive value for the body-composition changes in patients subjected to the different dietary interventions.
O6: To evaluate the influence of D-ß-hydroxybutyrate as well as other short-chain acyl-CoA precursor metabolites in human adipocytes lipolysis by in vitro experimentation and elucidate the influence of metabolite-sensitive histone modifications in the shaping of adipose transcriptional program and lipolysis sensitivity. O7: To develop a machine learning algorithm based on genetics, epigenetics, intestinal microbiome, and environmental factors for the prediction of the best dietary approach for weight loss in a personalized manner. To try to respond to these objectives, the investigators will apply two models: a randomized cross-over study testing three different dietary weight-loss interventions: MedDiet, KetoDiet, and IF with wash-out periods before each intervention.
Detailed description
The main objective of this project is to apply a precision medicine approach to try to explain the intra-individual variability of the response to different weight loss approaches: a balanced hypocaloric diet in macronutrients (MedDiet), a very low carbohydrate diet (KetoDiet) and an intermittent fasting (IF) approach, and try to establish in a personalized manner with the individual variability in genetics, metabolites, intestinal microbiome, and environmental factors the best dietary strategy for weight loss. As secondary objectives the investigators pretend to O1: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in insulin resistance, blood pressure, lipid levels and NASH markers after three different dietary interventions. O2: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in the body composition and the different ratio of free-fat/ fat mass loss after three different dietary interventions. O3: To determine the most effective intervention to increase the loss of fat mass, preserve the free-fat mass and trigger a better metabolic profile. O4: To follow-up changes in gut microbiota and DNA methylation after each of the cross-over dietary interventions. O5: To evaluate the transcriptional response of adipose tissue and elucidate its predictive value for the body-composition changes in patients subjected to the different dietary interventions. O6: To evaluate the influence of D-ß-hydroxybutyrate as well as other short-chain acyl-CoA precursor metabolites in human adipocytes lipolysis by in vitro experimentation and elucidate the influence of metabolite-sensitive histone modifications in the shaping of adipose transcriptional program and lipolysis sensitivity. O7: To develop a machine learning algorithm based on genetics, epigenetics, intestinal microbiome, and environmental factors for the prediction of the best dietary approach for weight loss in a personalized manner. To try to respond to these objectives, the investigators will apply two models: a randomized cross-over study testing three different dietary weight-loss interventions: MedDiet, KetoDiet, and IF with wash-out periods before each intervention in patients with obesity; and a second cellular approach with adipose tissue from the patients as well as with commercial cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized cross-over study testing three different dietary weight-loss interventions
| Arm | Type | Receives |
|---|---|---|
| A balanced hypocaloric diet in macronutrients (MedDiet). | Experimental | Other: MedDiet ArmMediterranean diet based on olive oil as main fat and regular consumption of vegetables (2 daily rations), fruits (3 daily rations), legumes (3 weekly rations), fish (3 weekly rations), with low consumption of red meat and meat products (less than twice a week), dairy foods (less than once a week) and no sweets, pastries or sugary drinks. Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein distributed in at least 4 meals (breakfast, lunch, afternoon snack and dinner). |
| A very low carbohydrate diet (KetoDiet). | Experimental | Other: KetoDiet ArmDiet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein |
| An intermittent fasting (IF) approach. | Experimental | Other: IF ArmIn this diet subjects alternate norm caloric diet during 24 h (according to Harris-Benedict equation) and a diet including only 25% of caloric requirements the following 24 h (this day diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants aged ≥ 18 and <70 years old who were derived to the obesity-management unit of the Endocrinology and Nutrition Unit of the Virgen de la Victoria Hospital (Málaga).
- BMI between 35 and 45 kg/m2.
Key exclusion criteria (4 listed)
- Pregnant or lactating
- Following a prescribed diet for any reason in the past 3 months
- Celiac disease, Crohn's disease or any condition altering nutritional requirements.
- Allergies or food intolerances, as well as antibiotics treatment or usual probiotics intake.
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 |
|---|---|---|
| MedDiet ArmA balanced hypocaloric diet in macronutrients (MedDiet) | Other | A balanced hypocaloric diet in macronutrients (MedDiet). |
| KetoDiet ArmA very low carbohydrate diet (KetoDiet). | Other | A very low carbohydrate diet (KetoDiet). |
| IF ArmAn intermittent fasting (IF) approach | Other | An intermittent fasting (IF) approach. |
Primary outcome
Changes in body weight after each intervention
Time frame: From baseline to 1 month
Weight in kg
13 secondary outcomes
Changes in body composition and in the ratio of free-fat / fat mass loss after the three different dietary interventions.
Time frame: From baseline to 1 month
Changes in the degree of insulin resistance.
Time frame: From baseline to 1 month
Changes in the systolic blood pressure
Time frame: From baseline to 1 month
Changes in the diastolic blood pressure
Time frame: From baseline to 1 month
Changes in lipid profile (triglycerides)
Time frame: From baseline to 1 month
Changes in lipid profile (cholesterol)
Time frame: From baseline to 1 month
Changes in the degree of ketosis
Time frame: From baseline to 1 month
Changes in gut microbiota
Time frame: From baseline to 1 month
DNA methylation.
Time frame: From baseline to 1 month
Changes in the punctuation in neurocognitive test - Trailmaking Test (A - B)
Time frame: From baseline to 1 month
Changes in the punctuation in neurocognitive test - Stroop
Time frame: From baseline to 1 month
Changes in the punctuation in neurocognitive test - WAISspan
Time frame: From baseline to 1 month
Changes in the punctuation in neurocognitive test - UPPS-P
Time frame: From baseline to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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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.
Franscisco J. Tinahones, MD, PhD. principal investigator
Instituto de Investigacion Biomedica de Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedDiet Arm, KetoDiet Arm and IF Arm in people with Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
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 2 inclusion and 4 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 26 Sep 2022. 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 Spain. 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 Isabel Moreno Indias, PhD. (951032647, Isabel.moreno@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight after each intervention (time frame: From baseline to 1 month). 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 26 Sep 2022.