DietNCT06115551
Fasting Mimicking Diet and Autophagy
A study testing Fasting Mimicking Diet in people with Diet and Autophagy, run by L-Nutra Inc at 1 site in United States.
Trial summary
This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Fasting Mimicking Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 30 Apr 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent;
- Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
- BMI 20-35 kg/m2 (inclusive) at screening;
Who cannot join
- Diabetes treatment other than diet or metformin monotherapy;
- History of gastric bypass;
- Subjects with recent weight loss (>5%), use of weight loss medication, participated in a weight loss program in the past 3 months;
- Type 1 diabetes (based on medical history provided at screening);
- Use of immune suppression drugs;
- Contraindication for study foods (special food needs and allergy);
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- Women who are pregnant;
- Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
- Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation* (*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Cellular Effects of Fasting Mimicking Diet In Humans: An Interventional, Randomized, Open Label, Parallel Assignment Study
This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.
Read the detailed description
Fasting-mimicking diet (FMD) was developed to mimic the endocrine and metabolic effects that water-only fasting, while providing a modest calories and essential nutrients. The health benefits of FMD are caused by several molecular mechanisms, including the reduction of body weight, ectopic fat storage, insulin levels, endogenous glucose production and IGF-1. Autophagy is a catabolic membrane-trafficking phenomenon observed in yeast and mammalian cells. Nutrient deprivation induces autophagy. Autophagy has been proposed to be a fundamental cellular process being linked to aging and the progression of age-related diseases. The objective of this study is to evaluate the effects of consuming two FMD formulations on the autophagy process in the cell.
- Being tested
- Fasting Mimicking Diet
- Keywords
- Fasting mimicking diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking DietCombination product
Also called ProLon, ProMete
FMD is a 5-day low calorie fasting-mimicking diet.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in the control group will be asked to keep their normal diet during the study period. |
| FMD1-ProLon | Experimental | Subjects in FMD1 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProLonTM). Receives: Combination Product: Fasting Mimicking Diet |
| FMD2-ProMete | Experimental | Subjects in FMD2 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProMeteTM). Receives: Combination Product: Fasting Mimicking Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autophagy flux
PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). LC3BI to LC3BII conversion, the lipidation of MAP1LC3B/LC3B (microtubule-associated protein 1 light chain 3 β), in the PBMCs will be accessed by western blot.
Autophagy-dependent degradation of SQSTM1/p62, a receptor and scaffold protein interacting with LC3 and ubiquitinated proteins, will be accessed by western blot.
Measured: Baseline to day 8
Secondary outcomes (2)
Metabolomic change
Plasma will be analyzed by high throughput RNA sequencing for gene expression changes.
Measured: Baseline to day 8
Autophagy-related gene expression
PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). PBMC RNA samples will be analyzed using ultra high-performance liquid chromatography/tandem accurate mass spectrometry (UHPLC/MS/MS).
Measured: Baseline to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start2 May 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
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 DietStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- L-Nutra Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Espinoza, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115551
- Sponsor's protocol ID
- LNT22-017
- Status last verified
- Apr 2024
- First submitted
- 20 Oct 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Espinoza SE, Park S, Connolly G, Qi W, Zhang N, Semwal M, Li Y, Lauzon M, Salmon AB, Hsu W, Wei M, Musi N. Effect of fasting-mimicking diet on markers of autophagy and metabolic health in human subjects. Geroscience. 2025 Dec 11. doi: 10.1007/s11357-025-02035-4. Online ahead of print.
PubMed 41372565
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Effects of Fasting Mimicking Diet In Humans: An Interventional, Randomized, Open Label, Parallel Assignment Study
- ClinicalTrials.gov ID
- NCT06115551
- Acronym / sponsor ID
- LNT22-017
- Keywords
- Fasting mimicking diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- L-Nutra IncIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.
Detailed description
Fasting-mimicking diet (FMD) was developed to mimic the endocrine and metabolic effects that water-only fasting, while providing a modest calories and essential nutrients. The health benefits of FMD are caused by several molecular mechanisms, including the reduction of body weight, ectopic fat storage, insulin levels, endogenous glucose production and IGF-1. Autophagy is a catabolic membrane-trafficking phenomenon observed in yeast and mammalian cells. Nutrient deprivation induces autophagy. Autophagy has been proposed to be a fundamental cellular process being linked to aging and the progression of age-related diseases. The objective of this study is to evaluate the effects of consuming two FMD formulations on the autophagy process in the cell.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in the control group will be asked to keep their normal diet during the study period. |
| FMD1-ProLon | Experimental | Combination Product: Fasting Mimicking DietSubjects in FMD1 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProLonTM). |
| FMD2-ProMete | Experimental | Combination Product: Fasting Mimicking DietSubjects in FMD2 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProMeteTM). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability and willingness to provide written informed consent;
- Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
- BMI 20-35 kg/m2 (inclusive) at screening;
Key exclusion criteria (9 listed)
- Diabetes treatment other than diet or metformin monotherapy;
- History of gastric bypass;
- Subjects with recent weight loss (>5%), use of weight loss medication, participated in a weight loss program in the past 3 months;
- Type 1 diabetes (based on medical history provided at screening);
- Use of immune suppression drugs;
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 |
|---|---|---|
| Fasting Mimicking DietAlso: ProLon, ProMeteFMD is a 5-day low calorie fasting-mimicking diet. | Combination product | FMD1-ProLon, FMD2-ProMete |
Primary outcome
Autophagy flux
Time frame: Baseline to day 8
PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). LC3BI to LC3BII conversion, the lipidation of MAP1LC3B/LC3B (microtubule-associated protein 1 light chain 3 β), in the PBMCs will be accessed by western blot. Autophagy-dependent degradation of SQSTM1/p62, a receptor and scaffold protein interacting with LC3 and ubiquitinated proteins, will be accessed by western blot.
2 secondary outcomes
Metabolomic change
Time frame: Baseline to day 8
Autophagy-related gene expression
Time frame: Baseline to day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 41372565Espinoza SE, Park S, Connolly G, Qi W, Zhang N, Semwal M, Li Y, Lauzon M, Salmon AB, Hsu W, Wei M, Musi N. Effect of fasting-mimicking diet on markers of autophagy and metabolic health in human subjects. Geroscience. 2025 Dec 11. doi: 10.1007/s11357-025-02035-4. Online ahead of print.
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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.
Sara Espinoza, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting Mimicking Diet in people with Diet and Autophagy, run by L-Nutra Inc at 1 site in United States.
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 3 inclusion and 9 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 4 Apr 2024. 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 United States. 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?
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?
Autophagy flux (time frame: Baseline to day 8). 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 NCT06115551, 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 4 Apr 2024.