ObesityNCT05031572
Energy -Sensing Metabolites in Caloric Restriction
A study testing dietary intervention in people with Obesity and Insulin Sensitivity/Resistance, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
General integrated goal of the coordinated project: To elucidate the role of succinate and other metabolites derived from the intestinal microbiota such as Short Chain Fatty Acids (SCFAs), as energy sensing metabolites in the context of obesity and type 2 diabetes (T2D). Specific objectives of Subproject 1 (SP1): 1a. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Sensitivity/Resistance, Diabetes Type 2
- What is being tested?
- dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2021to 1 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- White men and women between 18 and 65 years of age.
- BMI range between 25 and 40 kg/m2
- Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
- Signature of the informed consent for participation in the study.
Who cannot join
- Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
- Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma)
- Pregnancy and lactation.
- Vegetarians or subjects subjected to an irregular diet.
- Patients with severe eating disorders.
- Patients with clinical symptoms and signs of infection in the previous month.
Show all 10Show fewer
- Patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs.
- Recent antibiotic treatment.
- Psychiatric history.
- Uncontrolled alcoholism or drug abuse.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Joan XXIII de Tarragona. IISPV
Tarragona, 43005
About this study
Official title: New Energy-sensing Metabolites: Beneficial Effects on Metabolic Health in Obesity Comparing Diary Caloric Restriction vs Intermittent Fasting. A Randomized Cross-over Study
General integrated goal of the coordinated project:
To elucidate the role of succinate and other metabolites derived from the intestinal microbiota such as Short Chain Fatty Acids (SCFAs), as energy sensing metabolites in the context of obesity and type 2 diabetes (T2D).
Specific objectives of Subproject 1 (SP1): 1a. - To investigate whether intermittent fasting (IF) is better than Continued Daily Caloric Restriction (DCR) in terms of metabolic improvement through the study of: 1) the dynamics of gastrointestinal hormones and energy sensing metabolites, 2) the intestinal microbiome, 3) variability on succinate and SCFAs, MCFAs and Biliary Acid after weight loss; Methodology: clinical study: randomized, cross-over design, study participants (n=15) will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol. Clinical, anthropometrical and functional studies. Metabolomics for gut derived metabolites in plasma. Enteroendocrine gastrointestinal dynamics. Metagenomic analysis.
Read the detailed description
To investigate whether IF is better than DCR in terms of metabolic improvement through the study of:
- the dynamics of gastrointestinal hormones and energy sensing metabolites
- the intestinal microbiome
- variability on succinate and SCFAs MCFAs and BA after weight loss
Human study protocol:
A pilot clinical trial in human study participants will be assayed. Participants for intermittent fasting (IF) will be asked to fast for 24 hours on two days of the week (2/5 protocol).
1A.-Design: Utilizing a randomized, cross-over design, study participants (n=15) will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol. Each study period will be 8 weeks - total study period will be 16 weeks + a 4-week washout period between dietary exposures. The study participants will be adults who have obesity with a Body Mass Index (BMI)25 kg/m2 and 40 kg/m2 and have no contraindications for intermittent fasting (see inclusion and exclusion criteria below).
- Conditions
- Obesity, Insulin Sensitivity/Resistance, Diabetes Type 2
- Being tested
- dietary intervention
- Keywords
- obesity, diabetes, intermittent fasting, energy-sensing metabolites
- Medical subject headings
- Obesity, Insulin Resistance, Diabetes Mellitus, Type 2, Diabetes Mellitus, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary interventionOther
Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis
| Study group | Role | What they receive |
|---|---|---|
| conventional caloric restriction diet | Other | (DCR protocol): lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet Receives: Other: dietary intervention |
| Intermitent fasting | Other | Fasting for two days (non-consecutive) out of seven, with the fasting days separated by at least one day. Receives: Other: dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose)
Plasma concentrations of glucose during a meal test
Measured: basal and after 8 weeks
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin)
Plasma concentrations of insulin during a meal test
Measured: basal and after 8 weeks
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose after crossing arm)
Plasma concentrations of glucose during a meal test
Measured: at beginning of week 12 vs week 20
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin after crossing arm)
Plasma concentrations of insulin during a meal test
Measured: at beginning of week 12 vs week 20
Secondary outcomes (6)
1) the dynamics of gastrointestinal hormones and energy sensing metabolites
GLP-1; GLP-2 during a meal test
Measured: 8 weeks - 20 weeks
2) Analysis of microbial species in fecal samples (gut flora)
intestinal microbiome after each interventional period
Measured: 8 weeks - 20 weeks
variability on succinate after weight loss
quantification of succinate
Measured: 8 weeks - 20 weeks
variability on Short-chain fatty acids (SCFAs) after weight loss
quantification of SCFAs
Measured: 8 weeks - 20 weeks
variability on Medium-chain fatty acids (MCFAs) after weight loss
quantification of MACFAs
Measured: 8 weeks - 20 weeks
variability on biliary acids (BA) after weight loss
quantification of BA
Measured: 8 weeks - 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Aug 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
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
- clinical study: randomized, cross-over design, study participants will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Josep Vendrell, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Joan J Vendrell, PhD, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031572
- Sponsor's protocol ID
- PI20/00338
- Status last verified
- Oct 2022
- First submitted
- 20 Aug 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be upon request directly to the PI
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Energy-sensing Metabolites: Beneficial Effects on Metabolic Health in Obesity Comparing Diary Caloric Restriction vs Intermittent Fasting. A Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT05031572
- Acronym / sponsor ID
- PI20/00338
- Conditions
- Obesity, Insulin Sensitivity/Resistance, Diabetes Type 2
- Keywords
- obesity, diabetes, intermittent fasting, energy-sensing metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 2 Sep 2021 (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.
General integrated goal of the coordinated project:
To elucidate the role of succinate and other metabolites derived from the intestinal microbiota such as Short Chain Fatty Acids (SCFAs), as energy sensing metabolites in the context of obesity and type 2 diabetes (T2D).
Specific objectives of Subproject 1 (SP1): 1a. - To investigate whether intermittent fasting (IF) is better than Continued Daily Caloric Restriction (DCR) in terms of metabolic improvement through the study of: 1) the dynamics of gastrointestinal hormones and energy sensing metabolites, 2) the intestinal microbiome, 3) variability on succinate and SCFAs, MCFAs and Biliary Acid after weight loss; Methodology: clinical study: randomized, cross-over design, study participants (n=15) will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol. Clinical, anthropometrical and functional studies. Metabolomics for gut derived metabolites in plasma. Enteroendocrine gastrointestinal dynamics. Metagenomic analysis.
Detailed description
To investigate whether IF is better than DCR in terms of metabolic improvement through the study of:
- the dynamics of gastrointestinal hormones and energy sensing metabolites
- the intestinal microbiome
- variability on succinate and SCFAs MCFAs and BA after weight loss
Human study protocol:
A pilot clinical trial in human study participants will be assayed. Participants for intermittent fasting (IF) will be asked to fast for 24 hours on two days of the week (2/5 protocol).
1A.-Design: Utilizing a randomized, cross-over design, study participants (n=15) will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol. Each study period will be 8 weeks - total study period will be 16 weeks + a 4-week washout period between dietary exposures. The study participants will be adults who have obesity with a Body Mass Index (BMI)25 kg/m2 and 40 kg/m2 and have no contraindications for intermittent fasting (see inclusion and exclusion criteria below).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- clinical study: randomized, cross-over design, study participants will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol
| Arm | Type | Receives |
|---|---|---|
| conventional caloric restriction diet | Other | Other: dietary intervention(DCR protocol): lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet |
| Intermitent fasting | Other | Other: dietary interventionFasting for two days (non-consecutive) out of seven, with the fasting days separated by at least one day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- White men and women between 18 and 65 years of age.
- BMI range between 25 and 40 kg/m2
- Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
- Signature of the informed consent for participation in the study.
Key exclusion criteria (10 listed)
- Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
- Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma)
- Pregnancy and lactation.
- Vegetarians or subjects subjected to an irregular diet.
- Patients with severe eating disorders.
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 |
|---|---|---|
| dietary interventionChronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis | Other | Intermitent fasting, conventional caloric restriction diet |
Primary outcome
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose)
Time frame: basal and after 8 weeks
Plasma concentrations of glucose during a meal test
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin)
Time frame: basal and after 8 weeks
Plasma concentrations of insulin during a meal test
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose after crossing arm)
Time frame: at beginning of week 12 vs week 20
Plasma concentrations of glucose during a meal test
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin after crossing arm)
Time frame: at beginning of week 12 vs week 20
Plasma concentrations of insulin during a meal test
6 secondary outcomes
1) the dynamics of gastrointestinal hormones and energy sensing metabolites
Time frame: 8 weeks - 20 weeks
2) Analysis of microbial species in fecal samples (gut flora)
Time frame: 8 weeks - 20 weeks
variability on succinate after weight loss
Time frame: 8 weeks - 20 weeks
variability on Short-chain fatty acids (SCFAs) after weight loss
Time frame: 8 weeks - 20 weeks
variability on Medium-chain fatty acids (MCFAs) after weight loss
Time frame: 8 weeks - 20 weeks
variability on biliary acids (BA) after weight loss
Time frame: 8 weeks - 20 weeks
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 12 Oct 2022.
- Individual participant dataSharing planned: No. Data sharing will be upon request directly to the PI
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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.
Joan J Vendrell, PhD study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention in people with Obesity and Insulin Sensitivity/Resistance, run by Institut Investigacio Sanitaria Pere Virgili 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 4 inclusion and 10 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 12 Oct 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?
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?
To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose) (time frame: basal and after 8 weeks). The study lists 4 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 Oct 2022.