Heart DiseasePhase 1NCT00516620
Fruits, Vegetables, and Whole Grains: A Community-based Intervention
A Phase 1 study testing No further instruction, Food Delivery and Fruits (F), vegetables (V), and whole grain (WG) counseling in people with Heart Disease and Diabetes, run by University of Toronto at 1 site in Canada.
Trial summary
The aim of this study is to see if the investigators can encourage people to eat more fruits, vegetables and whole grains and drink less pop by giving them advice about their diet, or by providing them with samples of different kinds of foods. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Diabetes, Hypertension
- What is being tested?
- No further instruction, Food Delivery and Fruits (F), vegetables (V), and whole grain (WG) counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to May 2011
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents of households within the City of Toronto 416 calling area
- respond to advertisements in newspaper, on radio, and from flyers
- Eligible households will include at least one willing adult 18 years or older; able to communicate in English, at least one adult with BMI >/= 25
- Pregnant and breastfeeding mothers who fit the criteria above are eligible to join the study 6 months post-partum or 6 months after the cessation of breastfeeding
- Individuals who fit the inclusion criteria but recently (past 6 months) started blood pressure medication are eligible for the study once their blood pressure is under control
- Individuals who fit the inclusion criteria but recently started hypothyroid medication or diuretics will be eligible after 1 month of treatment
Who cannot join
- Residing outside of the 416 area code
- under 18 years of age
- actively following a special diet or weight-loss program
- major cardiovascular event in the previous 6 months
- recently (past 6 months) started blood pressure medication
- diabetes, liver disease, renal failure, cancer (or a history of malignancy), inflammatory bowel disease, individuals with acute or chronic infections, either bacterial or viral, or individuals suffering from chronic inflammatory diseases, irritable bowel syndrome, peanut or nut allergy, major surgery in the previous 6 months
- blood pressure greater than 145/95 on repeated measurements will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to see if the investigators can encourage people to eat more fruits, vegetables and whole grains and drink less pop by giving them advice about their diet, or by providing them with samples of different kinds of foods. The investigators are interested in the effect this has on reducing the risk of chronic disease. The investigators will also be investigating how certain genes affect the choices people make about the foods they eat.
Read the detailed description
Governments and major national agencies throughout the western world concerned with chronic disease prevention (heart disease, stroke, diabetes, and cancer) uniformly advocate increased intakes of fruit, vegetables and whole grain cereals. All also agree that body weight reduction is central to reducing the risk of heart disease, stroke, type 2 diabetes, and certain cancers. Nevertheless, there is no official advice encouraging increased consumption of these foods in order to achieve and maintain a healthy body weight. Most importantly, there are no intervention studies that have tested the assumption that increased intake of fruit, vegetables and whole grain cereals will promote a healthier body weight. Our study will therefore address this issue to determine the effect of an increased intake of fruit, vegetables, and whole grain cereals on body weight, the intensity of effort required to achieve compliance, the durability of this habit, genetic determinants, and the effect on biomarkers of chronic disease risk.
We will ask approximately 780 families to take part in this study. We will invite households to take part if there is at least one adult who is eligible for our study, and who agrees to participate.
To be eligible for this study, participants must be at least 18 years old and have no medical conditions that would make it unsafe for them to take part. Before beginning the study, the medical history and other measures will be checked to ensure participant safety and suitability for participating in the study.
This study consists of three parts. If agreement to participate is given, the first part is to make an appointment to come to our study clinic to give a fasting blood sample (baseline measurements), about 40mL of blood. The clinic visit will last approximately 40 minutes. All participants will be asked to complete a short checklist about their medical history, which includes information to make sure that they and their household are eligible for participation. Body fat measurements will also be made using a non-invasive, very simple machine called Futrex as well as height, weight, waist-to-hip ratio, and blood pressure. Part of the blood sample will be used for a health screen to ensure subject safety and suitability for participating in the study. Blood samples will be stored in a secured location and analyzed at the end of the study for cholesterol levels and other risk factors for heart disease. Part of the blood sample will be used in DNA analysis to help us understand the genes related to food intake and metabolism. We will also ask all participants to complete a questionnaire package about their eating habits and their physical activity either prior to the clinic visit or at the end of the clinic visit. Once the questionnaires are completed and returned to the study office, the second part of the study will commence.
The second part is the intervention itself, lasting six months. If households are deemed to be eligible, they will be 'randomized' into one of eight study groups with all groups receiving Canada's Food Guide \& Physical Activity Guide. The study groups involve a combination of different kinds of dietary advice and provision of fruit, vegetables, and whole grain cereals.
- Treatment 1: no food provision or dietary advice.
- Treatment 2: food delivery.
- Treatment 3: counseling on fruit, vegetables and whole grains.
- Treatment 4: counseling to reduce soft drink intake.
- Treatment 5: food delivery AND counseling on fruit, vegetables and whole grains.
- Treatment 6: food delivery AND counseling to reduce soft drink intake.
- Treatment 7: counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake.
- Treatment 8: food delivery AND counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake.
All food boxes are prepared and delivered by Food Share, a Toronto-based non-profit organization that has an existing system for home delivery of nutritious food boxes. If participants do receive dietary counseling, it will involve a phone call once a week for the first month (for about 20 minutes) then a phone call once a month for the next 5 months. At the end of six months, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures.
The third part is a follow-up 12 months after the end of the intervention. Again, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures.
- Conditions
- Heart Disease, Diabetes, Hypertension
- Being tested
- No further instruction, Food Delivery, Fruits (F), vegetables (V), and whole grain (WG) counseling, Counseling to reduce soft drink intake., Food Delivery & F, V & WG counseling.
- Keywords
- Body Weight
- Medical subject headings
- Heart Diseases, Diabetes Mellitus, Hypertension, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No further instructionBehavioural
Also called Control
Participants receive Health Canada's Food Guide and Physical Activity Guide and no other intervention for the 6 months of the intervention period.
Food DeliveryBehavioural
Participants receive Canada's Food Guide and Physical Activity guide, in addition to a a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.
Fruits (F), vegetables (V), and whole grain (WG) counselingBehavioural
Also called Fruit, Vegetable and Whole Grain Counseling
Participants receive Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Counseling to reduce soft drink intake.Behavioural
Also called Sweetened Soft Drink Counseling
Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Food Delivery & F, V & WG counseling.Behavioural
Also called Food Delivery, Fruit, Vegetable and Whole Grain Counseling
Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Food delivery & soft drink counselingBehavioural
Also called Food Delivery, and Sweetened Soft Drink Counseling
Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
F, V, WG & soft drink counselingBehavioural
Also called Fruit, Vegetable, Whole Grain, Sweetened Soft Drink Counseling
Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counseling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Food delivery and F,V, WG & soft drink counselingBehavioural
Also called Food Delivery, Fruit, Vegetable, Whole Grain, and Sweetened Soft Drink Counseling
Participants receive Health Canada's Food Guide and Physical Activity guide, receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants receive Health Canada's Food Guide and Physical Activity guide. Receives: Behavioral: No further instruction; Behavioral: Food Delivery; Behavioral: Fruits (F), vegetables (V), and whole grain (WG) counseling; Behavioral: Counseling to reduce soft drink intake.; Behavioral: Food Delivery & F, V & WG counseling.; Behavioral: Food delivery & soft drink counseling; Behavioral: F, V, WG & soft drink counseling; Behavioral: Food delivery and F,V, WG & soft drink counseling |
| 2 | Active comparator | Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products. Receives: Behavioral: Food Delivery; Behavioral: Food Delivery & F, V & WG counseling.; Behavioral: Food delivery & soft drink counseling; Behavioral: Food delivery and F,V, WG & soft drink counseling |
| 3 | Active comparator | Participants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products. Receives: Behavioral: Fruits (F), vegetables (V), and whole grain (WG) counseling; Behavioral: Food Delivery & F, V & WG counseling.; Behavioral: F, V, WG & soft drink counseling; Behavioral: Food delivery and F,V, WG & soft drink counseling |
| 4 | Active comparator | Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. Receives: Behavioral: Counseling to reduce soft drink intake.; Behavioral: Food delivery & soft drink counseling; Behavioral: F, V, WG & soft drink counseling; Behavioral: Food delivery and F,V, WG & soft drink counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Measured: 18 months
Secondary outcomes (1)
Biomarkers of diet and obesity-related chronic diseases (serum lipids, homocysteine and C-reactive protein) and genotypes
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJan 2005
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Cancer Care Ontario
- Responsible party
- Principal investigator, David Jenkins, University of Toronto
- Investigators
- Daivd JA Jenkins, MD, PhD, Principal investigator, University of Toronto, St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516620
- Sponsor's protocol ID
- REB 04-016C
- Other IDs
- CIHR-NET 105919
- Status last verified
- Dec 2015
- First submitted
- 13 Aug 2007
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jamnik J, Villa CR, Dhir SB, Jenkins DJA, El-Sohemy A. Prevalence of positive coeliac disease serology and HLA risk genotypes in a multiethnic population of adults in Canada: a cross-sectional study. BMJ Open. 2017 Oct 6;7(10):e017678. doi: 10.1136/bmjopen-2017-017678.
PubMed 39272232Wang J, Jamnik J, Garcia-Bailo B, Nielsen DE, Jenkins DJA, El-Sohemy A. ABO Genotype Does Not Modify the Association between the "Blood-Type" Diet and Biomarkers of Cardiometabolic Disease in Overweight Adults. J Nutr. 2018 Apr 1;148(4):518-525. doi: 10.1093/jn/nxx074.
PubMed 29659952Jenkins DJA, Boucher BA, Ashbury FD, Sloan M, Brown P, El-Sohemy A, Hanley AJ, Willett W, Paquette M, de Souza RJ, Ireland C, Kwan N, Jenkins A, Pichika SC, Kreiger N. Effect of Current Dietary Recommendations on Weight Loss and Cardiovascular Risk Factors. J Am Coll Cardiol. 2017 Mar 7;69(9):1103-1112. doi: 10.1016/j.jacc.2016.10.089.
PubMed 28254171
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruits, Vegetables, and Whole Grains: A Community-based Intervention
- ClinicalTrials.gov ID
- NCT00516620
- Acronym / sponsor ID
- REB 04-016C
- Conditions
- Heart Disease, Diabetes, Hypertension
- Keywords
- Body Weight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Cancer Care Ontario
- Study start
- Jan 2005
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Aug 2007 (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.
The aim of this study is to see if the investigators can encourage people to eat more fruits, vegetables and whole grains and drink less pop by giving them advice about their diet, or by providing them with samples of different kinds of foods. The investigators are interested in the effect this has on reducing the risk of chronic disease. The investigators will also be investigating how certain genes affect the choices people make about the foods they eat.
Detailed description
Governments and major national agencies throughout the western world concerned with chronic disease prevention (heart disease, stroke, diabetes, and cancer) uniformly advocate increased intakes of fruit, vegetables and whole grain cereals. All also agree that body weight reduction is central to reducing the risk of heart disease, stroke, type 2 diabetes, and certain cancers. Nevertheless, there is no official advice encouraging increased consumption of these foods in order to achieve and maintain a healthy body weight. Most importantly, there are no intervention studies that have tested the assumption that increased intake of fruit, vegetables and whole grain cereals will promote a healthier body weight. Our study will therefore address this issue to determine the effect of an increased intake of fruit, vegetables, and whole grain cereals on body weight, the intensity of effort required to achieve compliance, the durability of this habit, genetic determinants, and the effect on biomarkers of chronic disease risk.
We will ask approximately 780 families to take part in this study. We will invite households to take part if there is at least one adult who is eligible for our study, and who agrees to participate.
To be eligible for this study, participants must be at least 18 years old and have no medical conditions that would make it unsafe for them to take part. Before beginning the study, the medical history and other measures will be checked to ensure participant safety and suitability for participating in the study.
This study consists of three parts. If agreement to participate is given, the first part is to make an appointment to come to our study clinic to give a fasting blood sample (baseline measurements), about 40mL of blood. The clinic visit will last approximately 40 minutes. All participants will be asked to complete a short checklist about their medical history, which includes information to make sure that they and their household are eligible for participation. Body fat measurements will also be made using a non-invasive, very simple machine called Futrex as well as height, weight, waist-to-hip ratio, and blood pressure. Part of the blood sample will be used for a health screen to ensure subject safety and suitability for participating in the study. Blood samples will be stored in a secured location and analyzed at the end of the study for cholesterol levels and other risk factors for heart disease. Part of the blood sample will be used in DNA analysis to help us understand the genes related to food intake and metabolism. We will also ask all participants to complete a questionnaire package about their eating habits and their physical activity either prior to the clinic visit or at the end of the clinic visit. Once the questionnaires are completed and returned to the study office, the second part of the study will commence.
The second part is the intervention itself, lasting six months. If households are deemed to be eligible, they will be 'randomized' into one of eight study groups with all groups receiving Canada's Food Guide \& Physical Activity Guide. The study groups involve a combination of different kinds of dietary advice and provision of fruit, vegetables, and whole grain cereals.
- Treatment 1: no food provision or dietary advice.
- Treatment 2: food delivery.
- Treatment 3: counseling on fruit, vegetables and whole grains.
- Treatment 4: counseling to reduce soft drink intake.
- Treatment 5: food delivery AND counseling on fruit, vegetables and whole grains.
- Treatment 6: food delivery AND counseling to reduce soft drink intake.
- Treatment 7: counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake.
- Treatment 8: food delivery AND counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake.
All food boxes are prepared and delivered by Food Share, a Toronto-based non-profit organization that has an existing system for home delivery of nutritious food boxes. If participants do receive dietary counseling, it will involve a phone call once a week for the first month (for about 20 minutes) then a phone call once a month for the next 5 months. At the end of six months, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures.
The third part is a follow-up 12 months after the end of the intervention. Again, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: No further instruction, Behavioral: Food Delivery, Behavioral: Fruits (F), vegetables (V), and whole grain (WG) counseling, Behavioral: Counseling to reduce soft drink intake., Behavioral: Food Delivery & F, V & WG counseling., Behavioral: Food delivery & soft drink counseling, Behavioral: F, V, WG & soft drink counseling, Behavioral: Food delivery and F,V, WG & soft drink counselingParticipants receive Health Canada's Food Guide and Physical Activity guide. |
| 2 | Active comparator | Behavioral: Food Delivery, Behavioral: Food Delivery & F, V & WG counseling., Behavioral: Food delivery & soft drink counseling, Behavioral: Food delivery and F,V, WG & soft drink counselingParticipants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products. |
| 3 | Active comparator | Behavioral: Fruits (F), vegetables (V), and whole grain (WG) counseling, Behavioral: Food Delivery & F, V & WG counseling., Behavioral: F, V, WG & soft drink counseling, Behavioral: Food delivery and F,V, WG & soft drink counselingParticipants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products. |
| 4 | Active comparator | Behavioral: Counseling to reduce soft drink intake., Behavioral: Food delivery & soft drink counseling, Behavioral: F, V, WG & soft drink counseling, Behavioral: Food delivery and F,V, WG & soft drink counselingParticipants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- residents of households within the City of Toronto 416 calling area
- respond to advertisements in newspaper, on radio, and from flyers
- Eligible households will include at least one willing adult 18 years or older; able to communicate in English, at least one adult with BMI >/= 25
- Pregnant and breastfeeding mothers who fit the criteria above are eligible to join the study 6 months post-partum or 6 months after the cessation of breastfeeding
- Individuals who fit the inclusion criteria but recently (past 6 months) started blood pressure medication are eligible for the study once their blood pressure is under control
Key exclusion criteria (7 listed)
- Residing outside of the 416 area code
- under 18 years of age
- actively following a special diet or weight-loss program
- major cardiovascular event in the previous 6 months
- recently (past 6 months) started blood pressure medication
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 |
|---|---|---|
| No further instructionAlso: ControlParticipants receive Health Canada's Food Guide and Physical Activity Guide and no other intervention for the 6 months of the intervention period. | Behavioural | 1 |
| Food DeliveryParticipants receive Canada's Food Guide and Physical Activity guide, in addition to a a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products. | Behavioural | 1, 2 |
| Fruits (F), vegetables (V), and whole grain (WG) counselingAlso: Fruit, Vegetable and Whole Grain CounselingParticipants receive Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months. | Behavioural | 1, 3 |
| Counseling to reduce soft drink intake.Also: Sweetened Soft Drink CounselingParticipants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months. | Behavioural | 1, 4 |
| Food Delivery & F, V & WG counseling.Also: Food Delivery, Fruit, Vegetable and Whole Grain CounselingParticipants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months. | Behavioural | 1, 2, 3 |
| Food delivery & soft drink counselingAlso: Food Delivery, and Sweetened Soft Drink CounselingParticipants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months. | Behavioural | 1, 2, 4 |
| F, V, WG & soft drink counselingAlso: Fruit, Vegetable, Whole Grain, Sweetened Soft Drink CounselingParticipants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counseling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months. | Behavioural | 1, 3, 4 |
| Food delivery and F,V, WG & soft drink counselingAlso: Food Delivery, Fruit, Vegetable, Whole Grain, and Sweetened Soft Drink CounselingParticipants receive Health Canada's Food Guide and Physical Activity guide, receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months. | Behavioural | 1, 2, 3, 4 |
Primary outcome
Body Weight
Time frame: 18 months
1 secondary outcome
Biomarkers of diet and obesity-related chronic diseases (serum lipids, homocysteine and C-reactive protein) and genotypes
Time frame: 18 months
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 9 Dec 2015.
- Derived from this study: PubMed 39272232Jamnik J, Villa CR, Dhir SB, Jenkins DJA, El-Sohemy A. Prevalence of positive coeliac disease serology and HLA risk genotypes in a multiethnic population of adults in Canada: a cross-sectional study. BMJ Open. 2017 Oct 6;7(10):e017678. doi: 10.1136/bmjopen-2017-017678.
- Derived from this study: PubMed 29659952Wang J, Jamnik J, Garcia-Bailo B, Nielsen DE, Jenkins DJA, El-Sohemy A. ABO Genotype Does Not Modify the Association between the "Blood-Type" Diet and Biomarkers of Cardiometabolic Disease in Overweight Adults. J Nutr. 2018 Apr 1;148(4):518-525. doi: 10.1093/jn/nxx074.
- Derived from this study: PubMed 28254171Jenkins DJA, Boucher BA, Ashbury FD, Sloan M, Brown P, El-Sohemy A, Hanley AJ, Willett W, Paquette M, de Souza RJ, Ireland C, Kwan N, Jenkins A, Pichika SC, Kreiger N. Effect of Current Dietary Recommendations on Weight Loss and Cardiovascular Risk Factors. J Am Coll Cardiol. 2017 Mar 7;69(9):1103-1112. doi: 10.1016/j.jacc.2016.10.089.
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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.
Daivd JA Jenkins, MD, PhD principal investigator
University of Toronto, St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing No further instruction, Food Delivery and Fruits (F), vegetables (V), and whole grain (WG) counseling in people with Heart Disease and Diabetes, run by University of Toronto 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 6 inclusion and 7 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 9 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 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.
What does this 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.
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?
Body Weight (time frame: 18 months). 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 NCT00516620, which also lists 3 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 9 Dec 2015.