AgingNCT02132091
Practicality of Intermittent Fasting and Its Effect on Markers of Aging and Oxidative Stress
A study testing Intermittent Fasting, 400 IU Vitamin E and 1000 mg Vitamin C in people with Aging and Metabolism, run by University of Florida at 1 site in United States.
Trial summary
Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover trial. The trial will consist of two, three-week periods of intermittent fasting, where subjects receive either antioxidant supplementation or placebo, the ordering of which will be randomly determined. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Metabolism
- What is being tested?
- Intermittent Fasting, 400 IU Vitamin E and 1000 mg Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Nov 2011
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index in the range of 20.0-30.0 kg/m2;
- Age between 19 and 30;
- Stable weight (change <±10%) for 3 months immediately prior to the study
- No history of metabolic disorders (e.g. non-diabetic), cardiovascular disease, or thyroid dysfunction
- No past or present eating disorders
- No acute or chronic inflammatory disorder
Show all 15Show fewer
- No more than moderate physical activity (i.e.,<3 hour/week of light exercise sessions for the past 3 months)
- No current medications to regulate blood sugar or lipids
- Not donated blood within 56 days of study start date
- No food allergies
- No dietary restrictions (e.g. vegetarianism and vegan)
- No heavy drinking (more than 15 drinks/week)
- No use of tobacco or recreational drugs within past 3 months
- Access to a microwave or stove
- Access to refrigeration
Who cannot join
- Inflexibility of schedule such that subject cannot attend blood draw appointments
- Unwillingness to pick-up and eat only study-provided food during the 8 weeks in which it is provided and for unwillingness to abstain from travel (>48hrs) during these same 8 weeks of the trial (travel is permitted during wash-out period)
- Unwillingness to abstain from tobacco, alcohol, recreational drugs, resveratrol or antioxidant supplements (other than study-provided) for the duration of study
- Women who are pregnant, breast-feeding or trying to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover trial. The trial will consist of two, three-week periods of intermittent fasting, where subjects receive either antioxidant supplementation or placebo, the ordering of which will be randomly determined. A one-week preconditioning will precede each invention period, and a two week "wash-out" period will follow the first intervention period. Serum-based assays will be performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins, and markers of mitochondrial biogenesis and aging.
The investigators hypothesize that an intermittent fasting diet in healthy young volunteers will improve these markers of cellular aging and that these beneficial effects will be abrogated by the supplementation of antioxidants. This study is a proof-of-principle study that will shed light on the mechanism and effects of IF as an anti-aging dietary intervention in the absence of weight loss. It will inform the design of dietary interventions that are both effective in improving markers of aging and feasible for patients to practice on a long-term basis.
- Conditions
- Aging, Metabolism
- Being tested
- Intermittent Fasting, 400 IU Vitamin E, 1000 mg Vitamin C
- Keywords
- Sirtuins, Calorie Restriction, Intermittent Fasting, Antioxidant, Aging, Metabolism, Mitochondria, Oxidative Stress
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
The intermittent fasting paradigm used in this study will require participants to alternate between days of feasting (175% of normal caloric intake) and fasting ( 25% of normal caloric intake). Food will be provided by University of Florida Clinical Research Center with macronutrient composition prepared according to the 2010 Dietary Guidelines for Americans.
400 IU Vitamin EDietary supplement
once each day in morning; oral pill form
1000 mg Vitamin CDietary supplement
500mg twice each day; morning and evening; oral pill form
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | Intermittent Fasting Receives: Other: Intermittent Fasting |
| Intermittent Fasting + Antioxidants | Experimental | Intermittent Fasting; 400 IU Vitamin E; 1000 mg Vitamin C Receives: Other: Intermittent Fasting; Dietary Supplement: 400 IU Vitamin E; Dietary Supplement: 1000 mg Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOD2 gene expression (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.
Note: SOD2 = Superoxide-dismutase-2
Measured: 3 weeks
SOD2 gene expression (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.
Note: SOD2 = Superoxide-dismutase-2
Measured: 3 weeks
Secondary outcomes (14)
GPx1 gene expression (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.
Note: GPx1 = Glutathione peroxidase 1
Measured: 3 weeks
SIRT1 gene expression (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.
Note SIRT1 = Sirtuin 1
Measured: 3 weeks
SIRT3 gene expression (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.
Note SIRT3 = Sirtuin 3
Measured: 3 weeks
mTFA gene expression (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.
Note: mTFA = mitochondrial transcription factor a
Measured: 3 weeks
NRF1 gene expression (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.
Note NRF1 = Nuclear respiratory factor 1
Measured: 3 weeks
8oxodG ratio (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using DNA extracted from venous blood.
Note: 8oxodG = 8-oxo-7,8-dihydro-2'-deoxyguanosine/2-deoxyguanosine
Measured: 3 weeks
8oxoG ratio (intermittent fasting)
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.
Note: 8oxoG ratio = 8-oxo-7,8 dihydroguanosine/guanosine
Measured: 3 weeks
GPx1 gene expression (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.
Note: GPx1 = Glutathione peroxidase 1
Measured: 3 weeks
SIRT1 gene expression (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.
Note SIRT1 = Sirtuin 1
Measured: 3 weeks
SIRT3 gene expression (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.
Note SIRT3 = Sirtuin 3
Measured: 3 weeks
mFTA gene expression (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.
Note: mTFA = mitochondrial transcription factor a
Measured: 3 weeks
NRF1 gene expression (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.
Note NRF1 = Nuclear respiratory factor 1
Measured: 3 weeks
8oxodG ratio (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using DNA extracted from venous blood.
Note: 8oxodG ratio = 8-oxo-7,8-dihydro-2'-deoxyguanosine/2-deoxyguanosine
Measured: 3 weeks
8oxoG ratio (antioxidant supplementation)
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.
Note: 8oxoG ratio = 8-oxo-7,8 dihydroguanosine/guanosine
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionNov 2011
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 AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mark L Brantly, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132091
- Sponsor's protocol ID
- IRB772011
- Other IDs
- TL1TR000066, UL1TR000064, 1P30AG028740
- Status last verified
- Dec 2015
- First submitted
- 5 May 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wegman MP, Guo MH, Bennion DM, Shankar MN, Chrzanowski SM, Goldberg LA, Xu J, Williams TA, Lu X, Hsu SI, Anton SD, Leeuwenburgh C, Brantly ML. Practicality of intermittent fasting in humans and its effect on oxidative stress and genes related to aging and metabolism. Rejuvenation Res. 2015 Apr;18(2):162-72. doi: 10.1089/rej.2014.1624.
PubMed 25546413
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
- ClinicalTrials.gov ID
- NCT02132091
- Acronym / sponsor ID
- IRB772011
- Conditions
- Aging, Metabolism
- Keywords
- Sirtuins, Calorie Restriction, Intermittent Fasting, Antioxidant, Aging, Metabolism, Mitochondria, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 May 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.
Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover trial. The trial will consist of two, three-week periods of intermittent fasting, where subjects receive either antioxidant supplementation or placebo, the ordering of which will be randomly determined. A one-week preconditioning will precede each invention period, and a two week "wash-out" period will follow the first intervention period. Serum-based assays will be performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins, and markers of mitochondrial biogenesis and aging.
The investigators hypothesize that an intermittent fasting diet in healthy young volunteers will improve these markers of cellular aging and that these beneficial effects will be abrogated by the supplementation of antioxidants. This study is a proof-of-principle study that will shed light on the mechanism and effects of IF as an anti-aging dietary intervention in the absence of weight loss. It will inform the design of dietary interventions that are both effective in improving markers of aging and feasible for patients to practice on a long-term basis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Other: Intermittent FastingIntermittent Fasting |
| Intermittent Fasting + Antioxidants | Experimental | Other: Intermittent Fasting, Dietary Supplement: 400 IU Vitamin E, Dietary Supplement: 1000 mg Vitamin CIntermittent Fasting; 400 IU Vitamin E; 1000 mg Vitamin C |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Body mass index in the range of 20.0-30.0 kg/m2;
- Age between 19 and 30;
- Stable weight (change <±10%) for 3 months immediately prior to the study
- No history of metabolic disorders (e.g. non-diabetic), cardiovascular disease, or thyroid dysfunction
- No past or present eating disorders
Key exclusion criteria (4 listed)
- Inflexibility of schedule such that subject cannot attend blood draw appointments
- Unwillingness to pick-up and eat only study-provided food during the 8 weeks in which it is provided and for unwillingness to abstain from travel (>48hrs) during these same 8 weeks of the trial (travel is permitted during wash-out period)
- Unwillingness to abstain from tobacco, alcohol, recreational drugs, resveratrol or antioxidant supplements (other than study-provided) for the duration of study
- Women who are pregnant, breast-feeding or trying to become pregnant
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 |
|---|---|---|
| Intermittent FastingThe intermittent fasting paradigm used in this study will require participants to alternate between days of feasting (175% of normal caloric intake) and fasting ( 25% of normal caloric intake). Food will be provided by University of Florida Clinical Research Center with macronutrient composition prepared according to the 2010 Dietary Guidelines for Americans. | Other | Intermittent Fasting, Intermittent Fasting + Antioxidants |
| 400 IU Vitamin Eonce each day in morning; oral pill form | Dietary supplement | Intermittent Fasting + Antioxidants |
| 1000 mg Vitamin C500mg twice each day; morning and evening; oral pill form | Dietary supplement | Intermittent Fasting + Antioxidants |
Primary outcome
SOD2 gene expression (intermittent fasting)
Time frame: 3 weeks
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood. Note: SOD2 = Superoxide-dismutase-2
SOD2 gene expression (antioxidant supplementation)
Time frame: 3 weeks
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood. Note: SOD2 = Superoxide-dismutase-2
14 secondary outcomes
GPx1 gene expression (intermittent fasting)
Time frame: 3 weeks
SIRT1 gene expression (intermittent fasting)
Time frame: 3 weeks
SIRT3 gene expression (intermittent fasting)
Time frame: 3 weeks
mTFA gene expression (intermittent fasting)
Time frame: 3 weeks
NRF1 gene expression (intermittent fasting)
Time frame: 3 weeks
8oxodG ratio (intermittent fasting)
Time frame: 3 weeks
8oxoG ratio (intermittent fasting)
Time frame: 3 weeks
GPx1 gene expression (antioxidant supplementation)
Time frame: 3 weeks
SIRT1 gene expression (antioxidant supplementation)
Time frame: 3 weeks
SIRT3 gene expression (antioxidant supplementation)
Time frame: 3 weeks
mFTA gene expression (antioxidant supplementation)
Time frame: 3 weeks
NRF1 gene expression (antioxidant supplementation)
Time frame: 3 weeks
8oxodG ratio (antioxidant supplementation)
Time frame: 3 weeks
8oxoG ratio (antioxidant supplementation)
Time frame: 3 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 14 Dec 2015.
- Derived from this study: PubMed 25546413Wegman MP, Guo MH, Bennion DM, Shankar MN, Chrzanowski SM, Goldberg LA, Xu J, Williams TA, Lu X, Hsu SI, Anton SD, Leeuwenburgh C, Brantly ML. Practicality of intermittent fasting in humans and its effect on oxidative stress and genes related to aging and metabolism. Rejuvenation Res. 2015 Apr;18(2):162-72. doi: 10.1089/rej.2014.1624.
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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.
Mark L Brantly, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting, 400 IU Vitamin E and 1000 mg Vitamin C in people with Aging and Metabolism, run by University of Florida 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 15 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: finished, as of the sponsor's last update on 14 Dec 2015. 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?
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?
SOD2 gene expression (intermittent fasting) (time frame: 3 weeks). 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?
On the ClinicalTrials.gov record for NCT02132091, 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 14 Dec 2015.