Cardiovascular DiseasesNUTSNCT04037943
NUTS for the Prevention of Cardiovascular Disease in Chinese Adults
A study testing Walnuts 30 grams and Walnuts 60 grams in people with Cardiovascular Diseases and Dyslipidemias, run by The George Institute for Global Health, China at 1 site in China.
Trial summary
This study evaluates the feasibility of walnuts supplementation among population of high CVD risks over a period of 6 months. 70 participants will be controls receiving non-edible gifts. 70 participants will be given 30 grams of walnuts everyday and 70 participants will be given 60 grams of walnuts a day. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Dyslipidemias
- What is being tested?
- Walnuts 30 grams and Walnuts 60 grams
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2019to 24 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A history of CVD, defined on the basis of a prior hospitalisation for a myocardial infarction or stroke, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (with or without stenting), peripheral revascularization (angioplasty or surgery), symptomatic with documented hemodynamically-significant carotid or peripheral vascular disease, or amputation secondary to vascular disease, OR
- Male aged >60 years, or female aged>65 years, AND
- With at least two of the following risk factors:
- Type 2 diabetes requiring treatment with at least two oral anti-hyperglycaemic agents and/or insulin
- Systolic blood pressure > 140 mmHg while on one or more antihypertensive agents
- Current daily smoking
- Dyslipidaemia defined as HDL-cholesterol<1.0mmol/L or LDL-cholesterol>6.0mmol/L
- Micro or macro albuminuria
Who cannot join
- Allergic to nuts (history of food allergy with hypersensitivity to any of the components of nuts)
- Other serious medical condition that prevents nut consumption (e.g. digestive disease with fat intolerance)
- Any medical condition thought to limit survival to less than 1 year
- Difficulty with consuming nuts (e.g. dental health issues that prevent chewing walnuts)
- Unwilling to consume nuts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
This study evaluates the feasibility of walnuts supplementation among population of high CVD risks over a period of 6 months. 70 participants will be controls receiving non-edible gifts. 70 participants will be given 30 grams of walnuts everyday and 70 participants will be given 60 grams of walnuts a day.
Read the detailed description
Increased consumption of nuts improves the levels of lipid risk factors associated with cardiovascular disease and consistently relates to lower risk of cardiovascular disease (CVD) in prospective cohort studies. The estimates of health effects and potential population benefits of increased consumption of nuts are based mostly on observational data and there remains considerable uncertainty about whether higher intake of nuts will actually reduce cardiovascular outcomes. To address this uncertainty will require a well-conducted, adequately powered, large-scale, randomised control trial that tests the causal relationship between nut intake and the risk of cardiovascular diseases.
We hereby designed a 6-month walnut supplementation trial in a rural area of China with high rates of CVD, to obtain data to support and help to refine the design of a future long-term large RCT testing the effect of nut supplementation on CVD risk. The main objectives of the current trial are to assess the acceptability and adherence to two different doses of walnut supplementation (30 and 60 grams per day). The exploratory objectives are to determine the effects of walnut supplementation on cardiovascular risk factors including blood lipids, fasting glucose, and body weight.
- Conditions
- Cardiovascular Diseases, Dyslipidemias
- Being tested
- Walnuts 30 grams, Walnuts 60 grams
- Keywords
- Alpha linolenic acid
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnuts 30 gramsDietary supplement
Roasted walnuts without salt or sugar.
Walnuts 60 gramsDietary supplement
Roasted walnuts without salt or sugar.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months. Receives: Dietary Supplement: Walnuts 30 grams |
| High-dose group | Experimental | High-dose group will received 60 grams of walnuts everyday during the study period of 6 months. Receives: Dietary Supplement: Walnuts 60 grams |
| Control group | No intervention | Control group will received non-edible gifts during the study period of 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention differences in blood plasma alpha linolenic acid between groups
Blood plasma alpha linolenic acid will be measured at baseline and 6 months (end of trial).
Measured: From baseline to 6 months
Secondary outcomes (2)
Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups
Using 24 hour dietary recall to estimate dietary nuts intake at baseline and 6 months (end of trial).
Measured: From baseline to 6 months
Differences in adherence and acceptability of walnuts between the high and low dose groups
The adherence and acceptability of the supplement walnuts assessed by questionnaires conducted in the two intervention groups.
Measured: From 2 week, 12 weeks to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start14 Oct 2019
- Primary completion30 Jul 2020
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- This study is a three-group parallel design trial. The paralele groups will be the control group, the low-dose intervention group, and the high-dose intervention group. Eligible participants will be randomly assigned to one of the three groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, China
- Sponsor type
- University, hospital or other
- Collaborators
- Ningxia Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037943
- Sponsor's protocol ID
- NUTS
- Acronym
- NUTS
- Status last verified
- Aug 2022
- First submitted
- 14 Jan 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu Y, Li N, Yan N, Pan XF, Li Q, Micha R, Mozaffarian D, Huffman MD, Wang Y, Neal B, Tian M, Zhao Y, Wu JHY. Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease. Nutr J. 2021 Jan 6;20(1):3. doi: 10.1186/s12937-020-00660-7.
PubMed 33407490
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
- ClinicalTrials.gov ID
- NCT04037943
- Acronym / sponsor ID
- NUTS / NUTS
- Conditions
- Cardiovascular Diseases, Dyslipidemias
- Keywords
- Alpha linolenic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- The George Institute for Global Health, ChinaUniversity, hospital or other
- Collaborators
- Ningxia Medical University
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 30 Jul 2019 (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 evaluates the feasibility of walnuts supplementation among population of high CVD risks over a period of 6 months. 70 participants will be controls receiving non-edible gifts. 70 participants will be given 30 grams of walnuts everyday and 70 participants will be given 60 grams of walnuts a day.
Detailed description
Increased consumption of nuts improves the levels of lipid risk factors associated with cardiovascular disease and consistently relates to lower risk of cardiovascular disease (CVD) in prospective cohort studies. The estimates of health effects and potential population benefits of increased consumption of nuts are based mostly on observational data and there remains considerable uncertainty about whether higher intake of nuts will actually reduce cardiovascular outcomes. To address this uncertainty will require a well-conducted, adequately powered, large-scale, randomised control trial that tests the causal relationship between nut intake and the risk of cardiovascular diseases.
We hereby designed a 6-month walnut supplementation trial in a rural area of China with high rates of CVD, to obtain data to support and help to refine the design of a future long-term large RCT testing the effect of nut supplementation on CVD risk. The main objectives of the current trial are to assess the acceptability and adherence to two different doses of walnut supplementation (30 and 60 grams per day). The exploratory objectives are to determine the effects of walnut supplementation on cardiovascular risk factors including blood lipids, fasting glucose, and body weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a three-group parallel design trial. The paralele groups will be the control group, the low-dose intervention group, and the high-dose intervention group. Eligible participants will be randomly assigned to one of the three groups.
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Dietary Supplement: Walnuts 30 gramsLow-dose group will received 30 grams of walnuts everyday during the study period of 6 months. |
| High-dose group | Experimental | Dietary Supplement: Walnuts 60 gramsHigh-dose group will received 60 grams of walnuts everyday during the study period of 6 months. |
| Control group | No intervention | –Control group will received non-edible gifts during the study period of 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- A history of CVD, defined on the basis of a prior hospitalisation for a myocardial infarction or stroke, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (with or without stenting), peripheral revascularization (angioplasty or surgery), symptomatic with documented hemodynamically-significant carotid or peripheral vascular disease, or amputation secondary to vascular disease, OR
- Male aged >60 years, or female aged>65 years, AND
- Type 2 diabetes requiring treatment with at least two oral anti-hyperglycaemic agents and/or insulin
- Systolic blood pressure > 140 mmHg while on one or more antihypertensive agents
- Current daily smoking
Key exclusion criteria (5 listed)
- Allergic to nuts (history of food allergy with hypersensitivity to any of the components of nuts)
- Other serious medical condition that prevents nut consumption (e.g. digestive disease with fat intolerance)
- Any medical condition thought to limit survival to less than 1 year
- Difficulty with consuming nuts (e.g. dental health issues that prevent chewing walnuts)
- Unwilling to consume nuts
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 |
|---|---|---|
| Walnuts 30 gramsRoasted walnuts without salt or sugar. | Dietary supplement | Low-dose group |
| Walnuts 60 gramsRoasted walnuts without salt or sugar. | Dietary supplement | High-dose group |
Primary outcome
Post-intervention differences in blood plasma alpha linolenic acid between groups
Time frame: From baseline to 6 months
Blood plasma alpha linolenic acid will be measured at baseline and 6 months (end of trial).
2 secondary outcomes
Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups
Time frame: From baseline to 6 months
Differences in adherence and acceptability of walnuts between the high and low dose groups
Time frame: From 2 week, 12 weeks to 6 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 Aug 2022.
- Derived from this study: PubMed 33407490Liu Y, Li N, Yan N, Pan XF, Li Q, Micha R, Mozaffarian D, Huffman MD, Wang Y, Neal B, Tian M, Zhao Y, Wu JHY. Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease. Nutr J. 2021 Jan 6;20(1):3. doi: 10.1186/s12937-020-00660-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnuts 30 grams and Walnuts 60 grams in people with Cardiovascular Diseases and Dyslipidemias, run by The George Institute for Global Health, China at 1 site in China.
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 8 inclusion and 5 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 Aug 2022. 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 China. 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?
Post-intervention differences in blood plasma alpha linolenic acid between groups (time frame: From baseline to 6 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 NCT04037943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.