EpigeneticsNCT03647449
Examining the Effects of Juice Fasting
A study testing Juice, Caloric restriction via Plant-based meals and Plant-based meal in people with Epigenetics and Microbiome, run by Northwestern University at 1 site in United States.
Trial summary
This study tests the effectiveness of dietary interventions that have the possibility to improve markers of gut health and improve general well-being. This study will allow healthcare professionals to learn how dietary interventions involving fasting can affect health. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Epigenetics, Microbiome
- What is being tested?
- Juice, Caloric restriction via Plant-based meals and Plant-based meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 31 Dec 2019
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects considered as healthy by the investigator based on medical history and completion of the screening questionnaire.
- Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
- Healthy male or female aged between 18 and 35 (included) years
- 18.5 ≤BMI ≤ 30 kg/m²
- Ability to give their informed consent in writing
Who cannot join
- Documented history of previous cardiovascular disease, including coronary heart disease (CHD) (angina, myocardial infarction, coronary revascularization procedures or existence of abnormal Q waves in the electrocardiogram (EKG)), stroke, syncope, and clinical peripheral artery disease with symptoms of intermittent claudication.
- Severe medical condition that may impair the ability of the person to participate in a nutrition intervention study (e.g. digestive disease with fat intolerance, advanced malignancy, or major neurological, psychiatric or endocrine disease including diabetes).
- Daily use of any prescription or non-prescription medication that has a high likelihood of impacting systemic inflammation (e.g. non-steroidal anti inflammatories or steroids), blood sugar control (e.g. medication for diabetes) or the human microbiome (e.g. antibiotics).
- Any other medical condition thought to limit survival to less than 1 year.
- Known immunodeficiency disorder
- Illegal drug use or chronic alcoholism or total daily alcohol intake >80 g/d.
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- Difficulties or major inconvenience to change dietary habits
- Impossibility to follow an elimination or juice fast diet, for religious reasons or due to the presence of disorders of chewing or swallowing (e.g., difficulties to consume nuts)
- A low predicted likelihood to change dietary habits according to the Prochaska and DiClemente stages of change model (Nigg, 1999).
- History of food allergy with hypersensitivity to any of the components of the juice or diet
- Patients with an acute infection or inflammation (e.g., pneumonia) are allowed to participate in the study 3 months after the resolution of their condition.
- Dietary restrictions due to medical (including allergies), religious, or other concerns
- Any diagnosis of allergic rhinitis, eczema, asthma, or inflammatory bowel disease (e.g. ulcerative colitis or Crohn's) from a health professional
Trial locations and contacts
1 site in 1 country.
About this study
This study tests the effectiveness of dietary interventions that have the possibility to improve markers of gut health and improve general well-being. This study will allow healthcare professionals to learn how dietary interventions involving fasting can affect health. Food is increasingly recognized as a core component of preventive and ameliorative health care. Juice fasting has quickly become one of the most popular self-prescribed dietary interventions in the United States. A wide variety of juice fasts are available in the popular market; a popular variation is the three-day juice fast. The purpose of this study is to assess the effects of a three-day juice fast on certain markers of age-related disease and bio-markers of longevity. In particular, this study will assess certain epigenetic markers, which measure how the environment (including diet) can change the way that genes are expressed without changing the genes themselves. The study will also assess the microbiome, and inflammatory and glycemic markers.
Read the detailed description
Up to 30 participants will be enrolled in the study and will be randomized into one of the three arms: the "juice fasting" arm, the "juice plus ad hoc" arm, and the "caloric restriction" arm. Participants will come into the lab for an initial visit, during which they will complete questionnaires on their usual diet and demographics and will be informed about their assignment to one of the three arms.
In all three arms, the three-day diet intervention will be preceded and followed by three days of self-conducted elimination diet. The pre-intervention diet will encourage participants to eat a healthy, light diet for three days (basic instructions: eat only fresh raw or cooked fruits and vegetables (preferably organic), whole grains and eggs; drink 8 glasses of water a day; avoid or eliminate alcohol, caffeine, sugar, processed foods, dairy, red meat, and gluten). The post- intervention diet will instruct participants to gradually return to eating solid foods, and limit strenuous exercise (basic instructions: follow a diet similar to the pre-intervention elimination diet; day 1 after the intervention: eat fruits \& green vegetables, and drink 8 glasses of water; day 2 add in: nuts, gluten-free grains like whole oats, quinoa, or brown rice; day 3 add in: organic meats, fish, \& gluten-containing grains).
Biological samples and self-reported outcomes will be collected at four time points: baseline (prior to the first elimination diet period), pre-intervention (after the elimination diet and before the three-day intervention), post-intervention (after the intervention), and 14-day post- intervention. At each time point, participants will complete questionnaire on quality of life (PROMIS - Global Health Scale, which is an NIH measure on an individual's' overall physical and psychological well-being; see appendix) and collect their stool samples. Participants will be provided self-administered tool kits and be taught how to collect the stool sample at their first lab visit. At each of the four time points, the research assistant will coordinate the collection of cheek swabs, saliva samples, and blood spot samples. Biometrics will also be collected at each time point (weight, waist circumference, and blood pressure).
Over the course of the study, participants will be instructed to keep a diet diary days one through nine to record their daily dietary intake. During the intervention period, the research team will also contact the participants for daily check-ins. Participants will not need to record diet data for the remaining 11 days of the post-intervention period.
At the conclusion of the study, participants will bring back the final biological samples (stool wipe and saliva), provide the set of samples, and be debriefed about the purposes of the study.
The biological samples collected will then be processed and assayed for microbiome, methylation, inflammatory markers, and glycemic markers.
- Conditions
- Epigenetics, Microbiome
- Being tested
- Juice, Caloric restriction via Plant-based meals, Plant-based meal
- Keywords
- Juice fasting; methylation; microbiome; caloric restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuiceDietary supplement
Participants will be drinking 800-900 kcal/day in cold-pressed juices.
Caloric restriction via Plant-based mealsBehavioural
Participants' caloric intake will be limited to 800-900 kcal/day.
Plant-based mealDietary supplement
Participants will be eating ~900 kcal/day in pre-prepared plant-based meals.
| Study group | Role | What they receive |
|---|---|---|
| Juice fast | Experimental | In the "juice fasting" arm, participants will be given vegetable/fruit pressed juices and be instructed to engage in a three-day juice fast diet totaling 800-900 kcal-per-day. The specific juices will be assigned for each day in order to maintain the calorie level. Receives: Dietary Supplement: Juice; Behavioral: Caloric restriction via Plant-based meals |
| Caloric restriction via Plant-based meals | Experimental | In the "caloric restriction diet" arm, participants will be on a whole-food plant-based diet totaling 800-900 kcal-per-day (matching the daily calories of juice fasting). Receives: Behavioral: Caloric restriction via Plant-based meals; Dietary Supplement: Plant-based meal |
| Juice plus ad hoc | Experimental | In the "juice plus ad hoc" arm, participants will be given the same juice for three days but continue with their usual diet in addition to the juice. For this arm, there is no restriction of caloric intake or restriction to liquid only. Receives: Dietary Supplement: Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change DNA Methylation at Day 7
The ratio of methylated signal to total signal and the M-value (log2 ratio of methylated signal over unmethylated signal) will be determined for each interrogated locus using Illumina's Infinium Methylation EPIC BeadChip
Measured: This outcome will be measured on day 7 of the study.
Secondary outcomes (39)
Baseline DNA Methylation
The ratio of methylated signal to total signal and the M-value (log2 ratio of methylated signal over unmethylated signal) will be determined for each interrogated locus using Illumina's Infinium Methylation EPIC BeadChip
Measured: This outcome will be measured on day 1 of the study.
Change DNA Methylation at Day 4
The ratio of methylated signal to total signal and the M-value (log2 ratio of methylated signal over unmethylated signal) will be determined for each interrogated locus using Illumina's Infinium Methylation EPIC BeadChip
Measured: This outcome will be measured on day 4 of the study.
Change DNA Methylation at Day 21
The ratio of methylated signal to total signal and the M-value (log2 ratio of methylated signal over unmethylated signal) will be determined for each interrogated locus using Illumina's Infinium Methylation EPIC BeadChip
Measured: This outcome will be measured on day 21 of the study.
PROMIS Global Health self-report
The PROMIS Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. and psychological well-being
Measured: This outcome will be measured on day 1 of the study.
PROMIS Global Health self-report, repeatable
The PROMIS Global Health self-report, described in Outcome 5, will be administered daily during the active portion of the study.
Measured: This outcome will be measured on day 4 of the study.
PROMIS Global Health self-report, repeatable
The PROMIS Global Health self-report, described in Outcome 5, will be administered daily during the active portion of the study.
Measured: This outcome will be measured on day 5 of the study.
PROMIS Global Health self-report, repeatable
The PROMIS Global Health self-report, described in Outcome 5, will be administered daily during the active portion of the study.
Measured: This outcome will be measured on day 6 of the study.
Baseline Blood Pressure
The investigators will measure systolic and diastolic blood pressure, which will be measured manually using a stethoscope and blood pressure cuff.
Measured: This outcome will be measured on day 1 of the study.
Blood Pressure at Day 4
The investigators will measure systolic and diastolic blood pressure, which will be measured manually using a stethoscope and blood pressure cuff.
Measured: This outcome will be measured on day 4 of the study.
Change in Blood Pressure at Day 7
The investigators will measure systolic and diastolic blood pressure, which will be measured manually using a stethoscope and blood pressure cuff.
Measured: This outcome will be measured on day 7 of the study.
Change in Blood Pressure at Day 21
The investigators will measure systolic and diastolic blood pressure, which will be measured manually using a stethoscope and blood pressure cuff.
Measured: This outcome will be measured on day 21 of the study.
Baseline Waist Circumference
Waist circumference will be measured according to CDC guidelines: the participant will stand, and a tape measure will be placed horizontally around their middle, just above the hip bones.
Measured: This outcome will be measured on day 1 of the study.
Waist Circumference at Day 4
Waist circumference will be measured according to CDC guidelines: the participant will stand, and a tape measure will be placed horizontally around their middle, just above the hip bones.
Measured: This outcome will be measured on day 4 of the study.
Change in Waist Circumference at Day 7
Waist circumference will be measured according to CDC guidelines: the participant will stand, and a tape measure will be placed horizontally around their middle, just above the hip bones.
Measured: This outcome will be measured on day 7 of the study.
Change in Waist Circumference at Day 21
Waist circumference will be measured according to CDC guidelines: the participant will stand, and a tape measure will be placed horizontally around their middle, just above the hip bones.
Measured: This outcome will be measured on day 21 of the study.
Baseline Weight
Weight will be measured using a digital scale and recorded in pounds
Measured: This outcome will be measured on day 1 of the study.
Weight at Day 4
Weight will be measured using a digital scale and recorded in pounds
Measured: This outcome will be measured on day 4 of the study.
Change in Weight at Day 7
Weight will be measured using a digital scale and recorded in pounds
Measured: This outcome will be measured on day 7 of the study.
Change in Weight at Day 21
Weight will be measured using a digital scale and recorded in pounds
Measured: This outcome will be measured on day 21 of the study.
Baseline C-Reactive Protein
C-reactive protein (CRP) is a blood test marker for inflammation in the body.
Measured: This outcome will be measured on day 1 of the study
C-Reactive Protein at Day 4
C-reactive protein (CRP) is a blood test marker for inflammation in the body.
Measured: This outcome will be measured on day 4 of the study
Change in C-Reactive Protein at Day 7
C-reactive protein (CRP) is a blood test marker for inflammation in the body.
Measured: This outcome will be measured on day 7 of the study
Change in C-Reactive Protein at Day 21
C-reactive protein (CRP) is a blood test marker for inflammation in the body.
Measured: This outcome will be measured on day 21 of the study
Baseline Interleukin-6
Interleukin-6 (IL-6) is an endogenous chemical which is active in inflammation, and in B cell maturation. Besides being an immune protein, it is also a pyrogen, and is responsible for fever in autoimmune, infectious or non-infectious disease.
Measured: This outcome will be measured on day 1 of the study.
Interleukin-6 at Day 4
Interleukin-6 (IL-6) is an endogenous chemical which is active in inflammation, and in B cell maturation. Besides being an immune protein, it is also a pyrogen, and is responsible for fever in autoimmune, infectious or non-infectious disease.
Measured: This outcome will be measured on day 4 of the study.
Change in Interleukin-6 at Day 7
Interleukin-6 (IL-6) is an endogenous chemical which is active in inflammation, and in B cell maturation. Besides being an immune protein, it is also a pyrogen, and is responsible for fever in autoimmune, infectious or non-infectious disease.
Measured: This outcome will be measured on day 7 of the study.
Change in Interleukin-6 at Day 21
Interleukin-6 (IL-6) is an endogenous chemical which is active in inflammation, and in B cell maturation. Besides being an immune protein, it is also a pyrogen, and is responsible for fever in autoimmune, infectious or non-infectious disease.
Measured: This outcome will be measured on day 21 of the study.
Baseline Insulin Level
A fasting insulin test will show fasting blood sugar levels.
Measured: This outcome will be measured on day 1 of the study.
Insulin Level at Day 4
A fasting insulin test will show fasting blood sugar levels.
Measured: This outcome will be measured on day 4 of the study.
Change in Insulin Level at Day 7
A fasting insulin test will show fasting blood sugar levels.
Measured: This outcome will be measured on day 7 of the study.
Change in Insulin Level at Day 21
A fasting insulin test will show fasting blood sugar levels.
Measured: This outcome will be measured on day 21 of the study.
Baseline Leptin
Leptin is an adipocyte-derived hormone that is essential for normal body weight regulation. Leptin production is under neuroendocrine control so that serum concentrations vary directly with the amount of triglycerides stored in adipose tissue depots.
Measured: This outcome will be measured on day 1 of the study.
Leptin at Day 4
Leptin is an adipocyte-derived hormone that is essential for normal body weight regulation. Leptin production is under neuroendocrine control so that serum concentrations vary directly with the amount of triglycerides stored in adipose tissue depots.
Measured: This outcome will be measured on day 4 of the study.
Change in Leptin at Day 7
Leptin is an adipocyte-derived hormone that is essential for normal body weight regulation. Leptin production is under neuroendocrine control so that serum concentrations vary directly with the amount of triglycerides stored in adipose tissue depots.
Measured: This outcome will be measured on day 7 of the study.
Change in Leptin at Day 21
Leptin is an adipocyte-derived hormone that is essential for normal body weight regulation. Leptin production is under neuroendocrine control so that serum concentrations vary directly with the amount of triglycerides stored in adipose tissue depots.
Measured: This outcome will be measured on day 21 of the study.
Baseline Gut microbiota
16S rRNA amplicon library created for taxonomic annotation analysis.
Measured: This outcome will be measured on day 1 of the study.
Gut microbiota at Day 4
16S rRNA amplicon library created for taxonomic annotation analysis.
Measured: This outcome will be measured on day 4 of the study.
Change in Gut microbiota at Day 7
16S rRNA amplicon library created for taxonomic annotation analysis.
Measured: This outcome will be measured on day 7 of the study.
Change in Gut microbiota at Day 21
16S rRNA amplicon library created for taxonomic annotation analysis.
Measured: This outcome will be measured on day 21 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start10 Jul 2018
- Primary completion11 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EpigeneticsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Ring, Northwestern University
- Investigators
- Melinda Ring, MD, FACP, Principal investigator, Osher Center for Integrative Medicine at Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647449
- Sponsor's protocol ID
- STU00206611
- Status last verified
- Feb 2020
- First submitted
- 16 Jul 2018
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Redman LM, Ravussin E. Caloric restriction in humans: impact on physiological, psychological, and behavioral outcomes. Antioxid Redox Signal. 2011 Jan 15;14(2):275-87. doi: 10.1089/ars.2010.3253. Epub 2010 Aug 28.
PubMed 20518700Fontana L, Partridge L, Longo VD. Extending healthy life span--from yeast to humans. Science. 2010 Apr 16;328(5976):321-6. doi: 10.1126/science.1172539.
PubMed 20395504Henning SM, Shao P, Qing-Yi L, Yang J, Huang J, Ru-Po L, Thames G, Heber D, Li Z. Health effects of 3-day fruit and vegetable juice fasting. Advanced Nutrition, 7(48A), 2016.
Rink SM, Mendola P, Mumford SL, Poudrier JK, Browne RW, Wactawski-Wende J, Perkins NJ, Schisterman EF. Self-report of fruit and vegetable intake that meets the 5 a day recommendation is associated with reduced levels of oxidative stress biomarkers and increased levels of antioxidant defense in premenopausal women. J Acad Nutr Diet. 2013 Jun;113(6):776-85. doi: 10.1016/j.jand.2013.01.019. Epub 2013 Mar 19.
PubMed 23522825Zheng J, Zhou Y, Li S, Zhang P, Zhou T, Xu DP, Li HB. Effects and Mechanisms of Fruit and Vegetable Juices on Cardiovascular Diseases. Int J Mol Sci. 2017 Mar 4;18(3):555. doi: 10.3390/ijms18030555.
PubMed 28273863
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Juice Fasting
- ClinicalTrials.gov ID
- NCT03647449
- Acronym / sponsor ID
- STU00206611
- Conditions
- Epigenetics, Microbiome
- Keywords
- Juice fasting; methylation; microbiome; caloric restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Aug 2018 (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 tests the effectiveness of dietary interventions that have the possibility to improve markers of gut health and improve general well-being. This study will allow healthcare professionals to learn how dietary interventions involving fasting can affect health. Food is increasingly recognized as a core component of preventive and ameliorative health care. Juice fasting has quickly become one of the most popular self-prescribed dietary interventions in the United States. A wide variety of juice fasts are available in the popular market; a popular variation is the three-day juice fast. The purpose of this study is to assess the effects of a three-day juice fast on certain markers of age-related disease and bio-markers of longevity. In particular, this study will assess certain epigenetic markers, which measure how the environment (including diet) can change the way that genes are expressed without changing the genes themselves. The study will also assess the microbiome, and inflammatory and glycemic markers.
Detailed description
Up to 30 participants will be enrolled in the study and will be randomized into one of the three arms: the "juice fasting" arm, the "juice plus ad hoc" arm, and the "caloric restriction" arm. Participants will come into the lab for an initial visit, during which they will complete questionnaires on their usual diet and demographics and will be informed about their assignment to one of the three arms.
In all three arms, the three-day diet intervention will be preceded and followed by three days of self-conducted elimination diet. The pre-intervention diet will encourage participants to eat a healthy, light diet for three days (basic instructions: eat only fresh raw or cooked fruits and vegetables (preferably organic), whole grains and eggs; drink 8 glasses of water a day; avoid or eliminate alcohol, caffeine, sugar, processed foods, dairy, red meat, and gluten). The post- intervention diet will instruct participants to gradually return to eating solid foods, and limit strenuous exercise (basic instructions: follow a diet similar to the pre-intervention elimination diet; day 1 after the intervention: eat fruits \& green vegetables, and drink 8 glasses of water; day 2 add in: nuts, gluten-free grains like whole oats, quinoa, or brown rice; day 3 add in: organic meats, fish, \& gluten-containing grains).
Biological samples and self-reported outcomes will be collected at four time points: baseline (prior to the first elimination diet period), pre-intervention (after the elimination diet and before the three-day intervention), post-intervention (after the intervention), and 14-day post- intervention. At each time point, participants will complete questionnaire on quality of life (PROMIS - Global Health Scale, which is an NIH measure on an individual's' overall physical and psychological well-being; see appendix) and collect their stool samples. Participants will be provided self-administered tool kits and be taught how to collect the stool sample at their first lab visit. At each of the four time points, the research assistant will coordinate the collection of cheek swabs, saliva samples, and blood spot samples. Biometrics will also be collected at each time point (weight, waist circumference, and blood pressure).
Over the course of the study, participants will be instructed to keep a diet diary days one through nine to record their daily dietary intake. During the intervention period, the research team will also contact the participants for daily check-ins. Participants will not need to record diet data for the remaining 11 days of the post-intervention period.
At the conclusion of the study, participants will bring back the final biological samples (stool wipe and saliva), provide the set of samples, and be debriefed about the purposes of the study.
The biological samples collected will then be processed and assayed for microbiome, methylation, inflammatory markers, and glycemic markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Juice fast | Experimental | Dietary Supplement: Juice, Behavioral: Caloric restriction via Plant-based mealsIn the "juice fasting" arm, participants will be given vegetable/fruit pressed juices and be instructed to engage in a three-day juice fast diet totaling 800-900 kcal-per-day. The specific juices will be assigned for each day in order to maintain the calorie level. |
| Caloric restriction via Plant-based meals | Experimental | Behavioral: Caloric restriction via Plant-based meals, Dietary Supplement: Plant-based mealIn the "caloric restriction diet" arm, participants will be on a whole-food plant-based diet totaling 800-900 kcal-per-day (matching the daily calories of juice fasting). |
| Juice plus ad hoc | Experimental | Dietary Supplement: JuiceIn the "juice plus ad hoc" arm, participants will be given the same juice for three days but continue with their usual diet in addition to the juice. For this arm, there is no restriction of caloric intake or restriction to liquid only. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects considered as healthy by the investigator based on medical history and completion of the screening questionnaire.
- Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
- Healthy male or female aged between 18 and 35 (included) years
- 18.5 ≤BMI ≤ 30 kg/m²
- Ability to give their informed consent in writing
Key exclusion criteria (13 listed)
- Documented history of previous cardiovascular disease, including coronary heart disease (CHD) (angina, myocardial infarction, coronary revascularization procedures or existence of abnormal Q waves in the electrocardiogram (EKG)), stroke, syncope, and clinical peripheral artery disease with symptoms of intermittent claudication.
- Severe medical condition that may impair the ability of the person to participate in a nutrition intervention study (e.g. digestive disease with fat intolerance, advanced malignancy, or major neurological, psychiatric or endocrine disease including diabetes).
- Daily use of any prescription or non-prescription medication that has a high likelihood of impacting systemic inflammation (e.g. non-steroidal anti inflammatories or steroids), blood sugar control (e.g. medication for diabetes) or the human microbiome (e.g. antibiotics).
- Any other medical condition thought to limit survival to less than 1 year.
- Known immunodeficiency disorder
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 |
|---|---|---|
| JuiceParticipants will be drinking 800-900 kcal/day in cold-pressed juices. | Dietary supplement | Juice fast, Juice plus ad hoc |
| Caloric restriction via Plant-based mealsParticipants' caloric intake will be limited to 800-900 kcal/day. | Behavioural | Caloric restriction via Plant-based meals, Juice fast |
| Plant-based mealParticipants will be eating ~900 kcal/day in pre-prepared plant-based meals. | Dietary supplement | Caloric restriction via Plant-based meals |
Primary outcome
Change DNA Methylation at Day 7
Time frame: This outcome will be measured on day 7 of the study.
The ratio of methylated signal to total signal and the M-value (log2 ratio of methylated signal over unmethylated signal) will be determined for each interrogated locus using Illumina's Infinium Methylation EPIC BeadChip
39 secondary outcomes
Baseline DNA Methylation
Time frame: This outcome will be measured on day 1 of the study.
Change DNA Methylation at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change DNA Methylation at Day 21
Time frame: This outcome will be measured on day 21 of the study.
PROMIS Global Health self-report
Time frame: This outcome will be measured on day 1 of the study.
PROMIS Global Health self-report, repeatable
Time frame: This outcome will be measured on day 4 of the study.
PROMIS Global Health self-report, repeatable
Time frame: This outcome will be measured on day 5 of the study.
PROMIS Global Health self-report, repeatable
Time frame: This outcome will be measured on day 6 of the study.
Baseline Blood Pressure
Time frame: This outcome will be measured on day 1 of the study.
Blood Pressure at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change in Blood Pressure at Day 7
Time frame: This outcome will be measured on day 7 of the study.
Change in Blood Pressure at Day 21
Time frame: This outcome will be measured on day 21 of the study.
Baseline Waist Circumference
Time frame: This outcome will be measured on day 1 of the study.
Waist Circumference at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change in Waist Circumference at Day 7
Time frame: This outcome will be measured on day 7 of the study.
Change in Waist Circumference at Day 21
Time frame: This outcome will be measured on day 21 of the study.
Baseline Weight
Time frame: This outcome will be measured on day 1 of the study.
Weight at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change in Weight at Day 7
Time frame: This outcome will be measured on day 7 of the study.
Change in Weight at Day 21
Time frame: This outcome will be measured on day 21 of the study.
Baseline C-Reactive Protein
Time frame: This outcome will be measured on day 1 of the study
C-Reactive Protein at Day 4
Time frame: This outcome will be measured on day 4 of the study
Change in C-Reactive Protein at Day 7
Time frame: This outcome will be measured on day 7 of the study
Change in C-Reactive Protein at Day 21
Time frame: This outcome will be measured on day 21 of the study
Baseline Interleukin-6
Time frame: This outcome will be measured on day 1 of the study.
Interleukin-6 at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change in Interleukin-6 at Day 7
Time frame: This outcome will be measured on day 7 of the study.
Change in Interleukin-6 at Day 21
Time frame: This outcome will be measured on day 21 of the study.
Baseline Insulin Level
Time frame: This outcome will be measured on day 1 of the study.
Insulin Level at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change in Insulin Level at Day 7
Time frame: This outcome will be measured on day 7 of the study.
Change in Insulin Level at Day 21
Time frame: This outcome will be measured on day 21 of the study.
Baseline Leptin
Time frame: This outcome will be measured on day 1 of the study.
Leptin at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change in Leptin at Day 7
Time frame: This outcome will be measured on day 7 of the study.
Change in Leptin at Day 21
Time frame: This outcome will be measured on day 21 of the study.
Baseline Gut microbiota
Time frame: This outcome will be measured on day 1 of the study.
Gut microbiota at Day 4
Time frame: This outcome will be measured on day 4 of the study.
Change in Gut microbiota at Day 7
Time frame: This outcome will be measured on day 7 of the study.
Change in Gut microbiota at Day 21
Time frame: This outcome will be measured on day 21 of the study.
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 27 Feb 2020.
- Background: PubMed 20518700Redman LM, Ravussin E. Caloric restriction in humans: impact on physiological, psychological, and behavioral outcomes. Antioxid Redox Signal. 2011 Jan 15;14(2):275-87. doi: 10.1089/ars.2010.3253. Epub 2010 Aug 28.
- Background: PubMed 20395504Fontana L, Partridge L, Longo VD. Extending healthy life span--from yeast to humans. Science. 2010 Apr 16;328(5976):321-6. doi: 10.1126/science.1172539.
- BackgroundHenning SM, Shao P, Qing-Yi L, Yang J, Huang J, Ru-Po L, Thames G, Heber D, Li Z. Health effects of 3-day fruit and vegetable juice fasting. Advanced Nutrition, 7(48A), 2016.
- Background: PubMed 23522825Rink SM, Mendola P, Mumford SL, Poudrier JK, Browne RW, Wactawski-Wende J, Perkins NJ, Schisterman EF. Self-report of fruit and vegetable intake that meets the 5 a day recommendation is associated with reduced levels of oxidative stress biomarkers and increased levels of antioxidant defense in premenopausal women. J Acad Nutr Diet. 2013 Jun;113(6):776-85. doi: 10.1016/j.jand.2013.01.019. Epub 2013 Mar 19.
- Background: PubMed 28273863Zheng J, Zhou Y, Li S, Zhang P, Zhou T, Xu DP, Li HB. Effects and Mechanisms of Fruit and Vegetable Juices on Cardiovascular Diseases. Int J Mol Sci. 2017 Mar 4;18(3):555. doi: 10.3390/ijms18030555.
- Individual participant dataSharing planned: Undecided
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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.
Melinda Ring, MD, FACP principal investigator
Osher Center for Integrative Medicine at Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juice, Caloric restriction via Plant-based meals and Plant-based meal in people with Epigenetics and Microbiome, run by Northwestern University 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 5 inclusion and 13 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 27 Feb 2020. 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?
Change DNA Methylation at Day 7 (time frame: This outcome will be measured on day 7 of the study.). 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 NCT03647449, which also lists 5 linked publications.
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 27 Feb 2020.