Healthy VolunteersPhase 1/2NCT02158897
Multi-cycle Prolon Diet
A Phase 1/2 study testing Prolon diet in people with Healthy Volunteers, run by University of Southern California at 1 site in United States.
Trial summary
Evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Prolon diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2016
- Phase
- Phase 1/2
- 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
- Generally healthy adults
- BMI >19 kg/m^2
Who cannot join
- Severe hypertension (systolic BP > 200 mm Hg and/or diastolic BP > 105 mm Hg).
- Underweight (BMI < 19 kg/m^2)
- Females who are pregnant or nursing
- Special dietary requirements incompatible with the study interventions
- Significant food allergies which would make the subject unable to consume the study food
- Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
Trial locations and contacts
1 site in 1 country.
United States1 site
Davis School of Gerontology
Los Angeles, California, 90089
About this study
Official title: Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases
Evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. Furthermore, STS improves risk factors associated with aging and age-related disease in rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in a pilot human trial. The objective of the study is to ascertain the impact of the fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months. The investigators hypothesize that the specially designed dietary regimen can reduce the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
Read the detailed description
The Phase I part of the study is designed as a randomized cross-over trial, including two arms: a Control arm and a multi-cycle special 5-day dietary regimen (Diet, 3 cycles) arm. After 3 cycles, the Control and Diet groups are crossed over such that the Control group will under-go dieting and the Diet group will return to normal diet. Participants will be monitored for body weight and physiological changes, as well as the adherence to the dietary intervention.
The Phase II part of the study is an expansion of the Phase I to ascertain the impact of the dietary intervention on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
Statistical methods: Paired samples t-test and Mann-Whitney test will be used to compare between Control and Diet groups as well as pre- and post-diet values.
- Conditions
- Healthy Volunteers
- Being tested
- Prolon diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolon dietOther
Also called Fasting-mimicking diet
3 cycles of a 5-day Prolon diet very month
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will consume their normal diet. Body weight and physiological change at two time points (approximately 2-3 months apart) will be examined. The participants will be crossed over to the diet group. |
| Prolon Diet | Experimental | Participants will be provided with a 5-day supply of fasting-mimicking diet, including energy bars, soups, drink packets and dietary supplements. Participants will diet for 3 cycles. Each one-month cycle consists of 5 days of dieting with a calorie intake estimated at 600-1200 calories per day. The rest of the month participants will eat normally. After 3 cycles, participants will be examined again after consuming their normal diet after 2-3 months. Receives: Other: Prolon diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility of the Prolon diet
Phase I: To obtain preliminary estimates of the feasibility and safety of a low calorie Prolon diet in adult subjects.
Measured: 1 and half years
Effect of Prolon diet on risk factors for metabolic syndrome and biomarkers of aging
Phase II: To ascertain the impact of the calorie restricted special diet on the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases: e.g. fasting glucose, glucose tolerance, blood pressure, abdominal obesity, lipid profile, circulating IGF-1 and IGFBP1.
Measured: 2 and half years
Secondary outcomes (1)
Changes in cognitive functions before and after the dietary intervention.
Effects of dieting on the brain using fMRI;
Effects of dieting on cognitive functions:
- Verbal memory and learning;
- Speed of processing/attention;
- Working memory;
- Executive function;
- Visuospatial construction and memory;
- Frequency of Forgetting;
Measured: 2 and half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Wei, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158897
- Sponsor's protocol ID
- HS-12-00391
- Status last verified
- Apr 2017
- First submitted
- 2 Jun 2014
- Last updated
- 6 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases
- ClinicalTrials.gov ID
- NCT02158897
- Acronym / sponsor ID
- HS-12-00391
- Conditions
- Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Jun 2014 (estimated)
- 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.
Evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. Furthermore, STS improves risk factors associated with aging and age-related disease in rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in a pilot human trial. The objective of the study is to ascertain the impact of the fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months. The investigators hypothesize that the specially designed dietary regimen can reduce the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
Detailed description
The Phase I part of the study is designed as a randomized cross-over trial, including two arms: a Control arm and a multi-cycle special 5-day dietary regimen (Diet, 3 cycles) arm. After 3 cycles, the Control and Diet groups are crossed over such that the Control group will under-go dieting and the Diet group will return to normal diet. Participants will be monitored for body weight and physiological changes, as well as the adherence to the dietary intervention.
The Phase II part of the study is an expansion of the Phase I to ascertain the impact of the dietary intervention on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
Statistical methods: Paired samples t-test and Mann-Whitney test will be used to compare between Control and Diet groups as well as pre- and post-diet values.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will consume their normal diet. Body weight and physiological change at two time points (approximately 2-3 months apart) will be examined. The participants will be crossed over to the diet group. |
| Prolon Diet | Experimental | Other: Prolon dietParticipants will be provided with a 5-day supply of fasting-mimicking diet, including energy bars, soups, drink packets and dietary supplements. Participants will diet for 3 cycles. Each one-month cycle consists of 5 days of dieting with a calorie intake estimated at 600-1200 calories per day. The rest of the month participants will eat normally. After 3 cycles, participants will be examined again after consuming their normal diet after 2-3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generally healthy adults
- BMI >19 kg/m^2
Key exclusion criteria (6 listed)
- Severe hypertension (systolic BP > 200 mm Hg and/or diastolic BP > 105 mm Hg).
- Underweight (BMI < 19 kg/m^2)
- Females who are pregnant or nursing
- Special dietary requirements incompatible with the study interventions
- Significant food allergies which would make the subject unable to consume the study food
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 |
|---|---|---|
| Prolon dietAlso: Fasting-mimicking diet3 cycles of a 5-day Prolon diet very month | Other | Prolon Diet |
Primary outcome
Safety and feasibility of the Prolon diet
Time frame: 1 and half years
Phase I: To obtain preliminary estimates of the feasibility and safety of a low calorie Prolon diet in adult subjects.
Effect of Prolon diet on risk factors for metabolic syndrome and biomarkers of aging
Time frame: 2 and half years
Phase II: To ascertain the impact of the calorie restricted special diet on the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases: e.g. fasting glucose, glucose tolerance, blood pressure, abdominal obesity, lipid profile, circulating IGF-1 and IGFBP1.
1 secondary outcome
Changes in cognitive functions before and after the dietary intervention.
Time frame: 2 and half years
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 6 Apr 2017.
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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 Phase 1/2 study testing Prolon diet in people with Healthy Volunteers, run by University of Southern California 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 2 inclusion and 6 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 6 Apr 2017. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety and feasibility of the Prolon diet (time frame: 1 and half years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.