Cardiovascular DiseasesDIGESTNCT01658137
Diet Intervention and GEnetic STudy (DIGEST-Pilot)
A study testing Prudent Diet and Typical Western Diet in people with Cardiovascular Diseases and Inflammation, run by McMaster University at 1 site in Canada.
Trial summary
Genetic factors contribute to risk factors for cardiovascular disease, such as blood lipids, blood pressure, obesity, diabetes, and may also influence dietary choices, physical activity, and responses to stress. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Inflammation, Dyslipidemias
- What is being tested?
- Prudent Diet and Typical Western Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Dec 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years old
- non-smokers
- Body-Mass-Index <=30 kg/m^2
- willing and able to cook, prepare, and eat provided study foods
Who cannot join
- Aged below 18 years or above 80 years
- current tobacco smoking
- Body mass index above 30 kg/m2
- Unwillingness or inability to cook, prepare and eat provided study foods (e.g. for medical, philosophical, or religious reasons)
- Excessive use of alcohol (>14 drinks/week in men; >7 drinks/week in women)
- Significant morbidity that would interfere with participation or assessment, including :
Show all 31Show fewer
- Cancer
- HIV
- chronic renal disease
- renal failure
- Hepatitis/Jaundice
- Liver Disease
- Chronic Obstructive Pulmonary Disease
- Inflammatory bowel disease (Crohn's / Colitis)
- High blood or urine sugar/diabetes
- High blood cholesterol or triglycerides
- Angina/Heart attack/Coronary artery disease
- Heart failure
- Other heart disease
- Angioplasty (balloon opening of an artery) or coronary bypass surgery
- Medications or nutritional supplements (including multivitamins) that could affect outcome measurements. Excluded medications would include:
- Lipid/cholesterol lowering pills
- Insulin/oral hypoglycemic agents
- Medication for stroke
- Antibiotics
- oral contraceptives
- hormone replacement therapy
- non-steroidal anti-inflammatory drugs
- corticosteroids
- unwillingness to stop nutritional supplements 1 week prior to and for duration of intervention
- anticipated difficulties maintaining body weight (e.g. athletic training)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intervention Trial to Understand the Mechanism Underlying the 9p21 Variant Interaction With High Fruits and Vegetable Consumption
Genetic factors contribute to risk factors for cardiovascular disease, such as blood lipids, blood pressure, obesity, diabetes, and may also influence dietary choices, physical activity, and responses to stress. The most robust genetic variant associated with myocardial infarction (MI) is the 9p21 variant, which may raise the risk of MI by up to 40% in those who carry 2 copies of the gene. The investigators recently found that among those who carry the 9p21 variant, the risk of MI may be "turned off" if individuals eat a diet high in fruits and vegetables. The investigators seek to determine how a "prudent" or "anti-inflammatory" diet interacts with the 9p21 risk allele to alter the risk of MI.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death globally. The majority of CVD is explained by conventional risk factors including cigarette smoking, abnormal lipids, high blood pressure, obesity, diabetes, and health behaviours including dietary intake, physical activity, and psychosocial stressors. Genetic factors contribute to the development of these risk factors, and directly to CVD through other novel pathways. Since the advent of high throughput chip-based genotyping, more than 30 genetic variants have been found to be associated with myocardial infarction. The most robust genetic variant which has been consistently associated with myocardial infarction and other forms of arterial disease is the 9p21 variant. This genetic variant located on Chromosome 9 is common in the population, with 50% of people carrying one copy of the risk allele, and an additional 25% of the population carrying two copies of the risk allele. Compared with those with no copies of the risk allele, the risk of myocardial infarction with one copy of the risk allele is 15-20% higher, and the increased risk among carriers of 2 risk alleles is 20-40%. To date the exact mechanism by which the 9p21 variant increases the risk of myocardial infarction is unknown, although some data suggests that other genes and pathways associated with cell proliferation and inflammation are involved. Recently we made the observation that among carriers of the 9p21 variant, the risk of MI may be "turned off" if individuals consumed a diet high in fruits and vegetables. However the "mechanism" underlying this interaction is unknown. We seek to discover how a "Prudent" (i.e. anti-inflammatory) diet interacts with the 9p21 risk allele(s) to alter the risk of myocardial infarction.
We postulate that a "Prudent" diet (i.e. a diet high in fruits, vegetables, whole grains, non-processed foods) in comparison to a "Western" or "inflammatory diet" (eg, a typical North American diet high in saturated fats and processed foods) will differentially alter the gene expression (measured by RNA) of the 9p21 locus, change the epigenetic marks in this region, and alter several inflammatory markers suspected to mediate the effect of 9p21 on CVD risk (eg, hs-CRP, IF-alpha21, IFN-γ , interleukin 1-alpha, interleukin 1-beta, and interleukin 6) among people with one or two copies of the risk allele compared to people without the risk allele.
The proposed study offers an unique approach to studying dietary relationships with endpoints believed to be influenced by 9p21 gene variants. Rather than testing nutritional supplements, our results will be generalizable to the setting of most dietary counseling practices, which aim to alter dietary patterns, not specific nutrients. This trial will help us to unravel the basis for gene-diet interactions and gain a greater understanding of how inflammation is linked to the development of atherosclerosis, CVD, and possibly some cancers.
- Being tested
- Prudent Diet, Typical Western Diet
- Keywords
- diet, dietary pattern, gene, gene expression, epigenomics, diet-gene interaction, inflammation, 9p21, fruits, vegetables
- Medical subject headings
- Cardiovascular Diseases, Inflammation, Dyslipidemias, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prudent DietOther
This intervention lasts 2 weeks (14 days).
Typical Western DietOther
This intervention lasts 2 weeks (14 days).
| Study group | Role | What they receive |
|---|---|---|
| Typical Western Diet | Active comparator | The comparator dietary pattern ("Typical Western Diet") approximates the inflammatory dietary pattern typically consumed by North Americans. It contains refined grains, processed foods, dairy fat, meats, sugar and high glycemic index foods, and few fruits, nuts, legumes, and vegetables. The fruits and vegetables are highly processed (e.g. juices) and lower in micronutrients than those in the intervention diet. The saturated fat content of this diet does not meet national guidelines for health. The polyunsaturated fat:saturated fat ratio is ~0.5 (low). Receives: Other: Typical Western Diet |
| Prudent Diet | Experimental | The experimental dietary pattern ("Prudent Diet") is based on intakes of foods hypothesized to have beneficial effects on inflammation and long-term health. This dietary pattern includes micronutrient and macronutrient levels consistent with healthy eating in epidemiological studies and randomized controlled trials. The diet is constructed with low-fat dairy products, fish, chicken, and lean meats to minimize saturated fat and increase protein and calcium. The diet is rich in fruits, vegetables, whole grains, nuts, legumes, and seeds that are good sources of potassium, magnesium, and dietary fiber. This diet provides a 'favorable' macronutrient profile that is low in saturated fat, has a polyunsaturated/saturated fat ratio of ~1.0 (high), and low in high glycemic index carbohydrates. Receives: Other: Prudent Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression measuring ANRIL production
Measured: baseline and 2 weeks
epigenetic marks
Measured: baseline and 2 weeks
Secondary outcomes (12)
high-sensitivity C-reactive protein
Biomarker of inflammation
Measured: baseline and 2 weeks
interferon-alpha-21
Biomarker of inflammation
Measured: baseline and 2 weeks
interferon-gamma
Biomarker of inflammation
Measured: baseline and 2 weeks
interleukin-1-alpha
Biomarker of inflammation
Measured: baseline and 2 weeks
total cholesterol
lipid risk factor for cardiovascular disease
Measured: baseline and 2 weeks
low-density lipoprotein-cholesterol
lipid risk factor for cardiovascular disease
Measured: baseline and 2 weeks
high-density lipoprotein-cholesterol
lipid risk factor for cardiovascular disease
Measured: baseline and 2 weeks
apolipoprotein-B
lipid risk factor for cardiovascular disease
Measured: baseline and 2 weeks
fasting glucose
indicator of insulin resistance
Measured: baseline and 2 weeks
systolic blood pressure
mmHg
Measured: baseline and 2 weeks
diastolic blood pressure
mmHg
Measured: baseline and 2 weeks
interleukin-6
Biomarker of inflammation
Measured: baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Anand, McMaster University
- Investigators
- Sonia S Anand, MD, PhD, Principal investigator, McMaster University; Hamilton Health Sciences Center; Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658137
- Sponsor's protocol ID
- DIGEST-Pilot
- Acronym
- DIGEST
- Status last verified
- Jun 2016
- First submitted
- 28 Jul 2012
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Because sensitive genetic material was collected as part of this pilot study, data from this study will not be shared.
Publications
Anand SS, Yusuf S. Stemming the global tsunami of cardiovascular disease. Lancet. 2011 Feb 12;377(9765):529-32. doi: 10.1016/S0140-6736(10)62346-X. Epub 2011 Feb 4. No abstract available.
PubMed 21295845O'Donnell CJ, Nabel EG. Genomics of cardiovascular disease. N Engl J Med. 2011 Dec 1;365(22):2098-109. doi: 10.1056/NEJMra1105239. No abstract available.
PubMed 22129254McPherson R, Pertsemlidis A, Kavaslar N, Stewart A, Roberts R, Cox DR, Hinds DA, Pennacchio LA, Tybjaerg-Hansen A, Folsom AR, Boerwinkle E, Hobbs HH, Cohen JC. A common allele on chromosome 9 associated with coronary heart disease. Science. 2007 Jun 8;316(5830):1488-91. doi: 10.1126/science.1142447. Epub 2007 May 3.
PubMed 17478681Do R, Xie C, Zhang X, Mannisto S, Harald K, Islam S, Bailey SD, Rangarajan S, McQueen MJ, Diaz R, Lisheng L, Wang X, Silander K, Peltonen L, Yusuf S, Salomaa V, Engert JC, Anand SS; INTERHEART investigators. The effect of chromosome 9p21 variants on cardiovascular disease may be modified by dietary intake: evidence from a case/control and a prospective study. PLoS Med. 2011 Oct;8(10):e1001106. doi: 10.1371/journal.pmed.1001106. Epub 2011 Oct 11.
PubMed 22022235Mente A, de Koning L, Shannon HS, Anand SS. A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Arch Intern Med. 2009 Apr 13;169(7):659-69. doi: 10.1001/archinternmed.2009.38.
PubMed 19364995Hu FB, Rimm EB, Stampfer MJ, Ascherio A, Spiegelman D, Willett WC. Prospective study of major dietary patterns and risk of coronary heart disease in men. Am J Clin Nutr. 2000 Oct;72(4):912-21. doi: 10.1093/ajcn/72.4.912.
PubMed 11010931
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention Trial to Understand the Mechanism Underlying the 9p21 Variant Interaction With High Fruits and Vegetable Consumption
- ClinicalTrials.gov ID
- NCT01658137
- Acronym / sponsor ID
- DIGEST / DIGEST-Pilot
- Keywords
- diet, dietary pattern, gene, gene expression, epigenomics, diet-gene interaction, inflammation, 9p21
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Aug 2012 (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.
Genetic factors contribute to risk factors for cardiovascular disease, such as blood lipids, blood pressure, obesity, diabetes, and may also influence dietary choices, physical activity, and responses to stress. The most robust genetic variant associated with myocardial infarction (MI) is the 9p21 variant, which may raise the risk of MI by up to 40% in those who carry 2 copies of the gene. The investigators recently found that among those who carry the 9p21 variant, the risk of MI may be "turned off" if individuals eat a diet high in fruits and vegetables. The investigators seek to determine how a "prudent" or "anti-inflammatory" diet interacts with the 9p21 risk allele to alter the risk of MI.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death globally. The majority of CVD is explained by conventional risk factors including cigarette smoking, abnormal lipids, high blood pressure, obesity, diabetes, and health behaviours including dietary intake, physical activity, and psychosocial stressors. Genetic factors contribute to the development of these risk factors, and directly to CVD through other novel pathways. Since the advent of high throughput chip-based genotyping, more than 30 genetic variants have been found to be associated with myocardial infarction. The most robust genetic variant which has been consistently associated with myocardial infarction and other forms of arterial disease is the 9p21 variant. This genetic variant located on Chromosome 9 is common in the population, with 50% of people carrying one copy of the risk allele, and an additional 25% of the population carrying two copies of the risk allele. Compared with those with no copies of the risk allele, the risk of myocardial infarction with one copy of the risk allele is 15-20% higher, and the increased risk among carriers of 2 risk alleles is 20-40%. To date the exact mechanism by which the 9p21 variant increases the risk of myocardial infarction is unknown, although some data suggests that other genes and pathways associated with cell proliferation and inflammation are involved. Recently we made the observation that among carriers of the 9p21 variant, the risk of MI may be "turned off" if individuals consumed a diet high in fruits and vegetables. However the "mechanism" underlying this interaction is unknown. We seek to discover how a "Prudent" (i.e. anti-inflammatory) diet interacts with the 9p21 risk allele(s) to alter the risk of myocardial infarction.
We postulate that a "Prudent" diet (i.e. a diet high in fruits, vegetables, whole grains, non-processed foods) in comparison to a "Western" or "inflammatory diet" (eg, a typical North American diet high in saturated fats and processed foods) will differentially alter the gene expression (measured by RNA) of the 9p21 locus, change the epigenetic marks in this region, and alter several inflammatory markers suspected to mediate the effect of 9p21 on CVD risk (eg, hs-CRP, IF-alpha21, IFN-γ , interleukin 1-alpha, interleukin 1-beta, and interleukin 6) among people with one or two copies of the risk allele compared to people without the risk allele.
The proposed study offers an unique approach to studying dietary relationships with endpoints believed to be influenced by 9p21 gene variants. Rather than testing nutritional supplements, our results will be generalizable to the setting of most dietary counseling practices, which aim to alter dietary patterns, not specific nutrients. This trial will help us to unravel the basis for gene-diet interactions and gain a greater understanding of how inflammation is linked to the development of atherosclerosis, CVD, and possibly some cancers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical Western Diet | Active comparator | Other: Typical Western DietThe comparator dietary pattern ("Typical Western Diet") approximates the inflammatory dietary pattern typically consumed by North Americans. It contains refined grains, processed foods, dairy fat, meats, sugar and high glycemic index foods, and few fruits, nuts, legumes, and vegetables. The fruits and vegetables are highly processed (e.g. juices) and lower in micronutrients than those in the intervention diet. The saturated fat content of this diet does not meet national guidelines for health. The polyunsaturated fat:saturated fat ratio is ~0.5 (low). |
| Prudent Diet | Experimental | Other: Prudent DietThe experimental dietary pattern ("Prudent Diet") is based on intakes of foods hypothesized to have beneficial effects on inflammation and long-term health. This dietary pattern includes micronutrient and macronutrient levels consistent with healthy eating in epidemiological studies and randomized controlled trials. The diet is constructed with low-fat dairy products, fish, chicken, and lean meats to minimize saturated fat and increase protein and calcium. The diet is rich in fruits, vegetables, whole grains, nuts, legumes, and seeds that are good sources of potassium, magnesium, and dietary fiber. This diet provides a 'favorable' macronutrient profile that is low in saturated fat, has a polyunsaturated/saturated fat ratio of ~1.0 (high), and low in high glycemic index carbohydrates. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years old
- non-smokers
- Body-Mass-Index <=30 kg/m^2
- willing and able to cook, prepare, and eat provided study foods
Key exclusion criteria (31 listed)
- Aged below 18 years or above 80 years
- current tobacco smoking
- Body mass index above 30 kg/m2
- Unwillingness or inability to cook, prepare and eat provided study foods (e.g. for medical, philosophical, or religious reasons)
- Excessive use of alcohol (>14 drinks/week in men; >7 drinks/week in women)
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 |
|---|---|---|
| Prudent DietThis intervention lasts 2 weeks (14 days). | Other | Prudent Diet |
| Typical Western DietThis intervention lasts 2 weeks (14 days). | Other | Typical Western Diet |
Primary outcome
gene expression measuring ANRIL production
Time frame: baseline and 2 weeks
epigenetic marks
Time frame: baseline and 2 weeks
12 secondary outcomes
high-sensitivity C-reactive protein
Time frame: baseline and 2 weeks
interferon-alpha-21
Time frame: baseline and 2 weeks
interferon-gamma
Time frame: baseline and 2 weeks
interleukin-1-alpha
Time frame: baseline and 2 weeks
total cholesterol
Time frame: baseline and 2 weeks
low-density lipoprotein-cholesterol
Time frame: baseline and 2 weeks
high-density lipoprotein-cholesterol
Time frame: baseline and 2 weeks
apolipoprotein-B
Time frame: baseline and 2 weeks
fasting glucose
Time frame: baseline and 2 weeks
systolic blood pressure
Time frame: baseline and 2 weeks
diastolic blood pressure
Time frame: baseline and 2 weeks
interleukin-6
Time frame: baseline and 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Background: PubMed 21295845Anand SS, Yusuf S. Stemming the global tsunami of cardiovascular disease. Lancet. 2011 Feb 12;377(9765):529-32. doi: 10.1016/S0140-6736(10)62346-X. Epub 2011 Feb 4. No abstract available.
- Background: PubMed 22129254O'Donnell CJ, Nabel EG. Genomics of cardiovascular disease. N Engl J Med. 2011 Dec 1;365(22):2098-109. doi: 10.1056/NEJMra1105239. No abstract available.
- Background: PubMed 17478681McPherson R, Pertsemlidis A, Kavaslar N, Stewart A, Roberts R, Cox DR, Hinds DA, Pennacchio LA, Tybjaerg-Hansen A, Folsom AR, Boerwinkle E, Hobbs HH, Cohen JC. A common allele on chromosome 9 associated with coronary heart disease. Science. 2007 Jun 8;316(5830):1488-91. doi: 10.1126/science.1142447. Epub 2007 May 3.
- Background: PubMed 22022235Do R, Xie C, Zhang X, Mannisto S, Harald K, Islam S, Bailey SD, Rangarajan S, McQueen MJ, Diaz R, Lisheng L, Wang X, Silander K, Peltonen L, Yusuf S, Salomaa V, Engert JC, Anand SS; INTERHEART investigators. The effect of chromosome 9p21 variants on cardiovascular disease may be modified by dietary intake: evidence from a case/control and a prospective study. PLoS Med. 2011 Oct;8(10):e1001106. doi: 10.1371/journal.pmed.1001106. Epub 2011 Oct 11.
- Background: PubMed 19364995Mente A, de Koning L, Shannon HS, Anand SS. A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Arch Intern Med. 2009 Apr 13;169(7):659-69. doi: 10.1001/archinternmed.2009.38.
- Background: PubMed 11010931Hu FB, Rimm EB, Stampfer MJ, Ascherio A, Spiegelman D, Willett WC. Prospective study of major dietary patterns and risk of coronary heart disease in men. Am J Clin Nutr. 2000 Oct;72(4):912-21. doi: 10.1093/ajcn/72.4.912.
- Individual participant dataSharing planned: No. Because sensitive genetic material was collected as part of this pilot study, data from this study will not be shared.
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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.
Sonia S Anand, MD, PhD principal investigator
McMaster University; Hamilton Health Sciences Center; Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prudent Diet and Typical Western Diet in people with Cardiovascular Diseases and Inflammation, run by McMaster University at 1 site in Canada.
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 31 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 7 Jun 2016. 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 Canada. 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?
gene expression measuring ANRIL production (time frame: baseline and 2 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 NCT01658137, which also lists 6 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 7 Jun 2016.