Does nut consumption decrease biological age and improve cardiovascular risk factors? Are cashews better than almonds?
| ISRCTN | ISRCTN75362861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75362861 |
| Secondary identifying numbers | PCT3E-19 |
- Submission date
- 18/12/2019
- Registration date
- 20/12/2019
- Last edited
- 17/04/2020
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Currently biological age can be measured by analyzing methylations in selected genes and calculate what is called accelerated aging index that takes into account the difference between biological age and chronological age. Although many studies have focused on measuring these indicators, very few have investigated through intervention studies how dietary components can influence decreasing biological age and accelerated aging. Curiously, nuts, which have been related in multiple studies with a better cardiometabolic profile and lower cardiovascular risk, have not been studied in this sense. The aim is to carry out an intervention study with nuts (50 g per day for 2 months continuously) and compare them with a control group in terms of improving cardiometabolic risk parameters, and fundamentally their impact on DNA methylation and decreasing biological age. It is also interesting to know if all nuts have the same effect or if there are differences. Cashew nuts have been little studied. In this study the cashew nuts will be analyzed in comparison with the raw almonds with skin, and all of them in turn with the control group. A longer-term follow-up will also be carried out, without active intervention with nuts, only recommending their respective consumptions. All this will serve to obtain data that we lack now and assess in the future a broader study including additional determinations.
Who can participate?
Volunteers recruited from the general population, between 25 and 50 years old, with BMI between 23 and 35 kg/m2
What does the study involve?
Participants are randomly allocated into three groups:
1. Intervention group with nuts A: standard diet with supplementation of almonds with raw skin (50 g/day for 2 months)
2. Intervention group with nuts B: standard diet with supplementation of cashew nuts (50 g/day for 2 months)
3. Control group without nuts: standard diet without nut intake (for 2 months)
This is followed by 10 additional months in which no nuts are supplied to any group, but advice is given to consume the nuts of the respective groups A and B, or in the control group to minimise as much as possible the consumption of nuts, until completing a period of 1 year, after which the parameters of interest are re-evaluated.
What are the possible benefits and risks of participating?
A possible benefit is to have the chance to help other people by contributing to medical research. Participants will be informed that no potential risks are expected.
Where is the study run from?
1. University of Valencia (Spain)
2. CIBER Fisiopatología de la Obesidad y Nutrición (Spain)
When is the study starting and how long is it expected to run for?
October 2019 to June 2021
Who is funding the study?
1. University of Valencia
2. CIBEROBN
3. Importaco
Who is the main contact?
Prof. Dolores Corella
dolores.corella@uv.es
Contact information
Scientific
Department of Preventive Medicine and CIBEROBN
Avda. Blasco Ibanez, 15
Valencia
46010
Spain
| Phone | +34 (0)963864800 |
|---|---|
| dolores.corella@uv.es |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of nut consumption on the improvement of cardiometabolic risk factors and decrease of biological age in the Mediterranean population: a randomized controlled trial |
| Study acronym | NUTS-ANTIAGING |
| Study objectives | The researchers hypothesized that a regular intake of nuts within a standardized diet is capable of improving several parameters of cardiometabolic risk including: anthropometric, blood pressure and biochemical, as well as in the pattern of DNA methylation as a biological indicator of cellular aging, compared to a control group. Additionally, they hypothesized that according to the nut consumed (almonds or cashew nuts), the improvements in certain parameters will be more specific. |
| Ethics approval(s) | Approved 07/11/2019, Institutional review board of Valencia University (human subjects) (Avda. Blasco Ibanez 13. Valencia, ZIP 46010, Spain; Tel: +34 (0)963864109; Email: vicerec.investigacio@uv.es), ref: UV-INV_ETICA-1206123 |
| Health condition(s) or problem(s) studied | Cardiometabolic risk and aging |
| Intervention | Participants will be randomized into three groups (1:1:2) by simple random assignment through a computer program. Therefore, 20, 20 and 40 subjects will be randomized to the intervention group A, intervention group B and to the control group, respectively: 1. Intervention group with nuts A: standard diet with supplementation of a single nut, almonds with raw skin (50g/day for 2 months) 2. Intervention group with nuts B: standard diet with supplementation of a single nut, cashew nuts (50 g/day, for 2 months) 3. Control group without nuts: standard diet without nut intake (for 2 months) This will be followed by a long-term (10 additional months) in which no nuts will be supplied to any group, but advice will be given to consume the nuts of the respective groups A and B, or to minimise as much as possible the consumption of nuts in the control group, until completing a period of 1 year, after which the parameters of interest will be re-evaluated. |
| Intervention type | Mixed |
| Primary outcome measure | All the outcome measures will be measured at baseline and after 2 months. In addition, for the primary outcomes and for the main secondary outcomes, measures after the 10 months of follow-up will be obtained. 1. Cardiovascular risk parameters measured as follows: 1.1. Anthropometric: including weight, height, waist circumference and body composition, measured by validated scales and bioimpedance 1.2. Blood pressure: systolic and diastolic blood pressure measured by trained personnel with a validated semiautomatic oscillometer using standard procedures 1.3. Fasting glucose, total colesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, liver and kidney enzymes, CRP and leptin measured in fasting plasma samples by standard procedures 1.4. DNA methylation measured in isolated DNA from blood by standard procedures using the SequenomMassARRAY platform or similar. Biological age calculated based on the methylation pattern according to standard procedures |
| Secondary outcome measures | All the outcome measures will be measured at baseline and after 2 months. In addition, for the primary outcomes and for the main secondary outcomes, measures after the 10 months of follow-up will be obtained. 1. Dietary patterns measured by validated questionnaires including the 14-item Mediterranean diet adherence score and the 17-item Mediterranean diet score, as well as by food frequency questionnaires 2. Inflammatory markers measured in blood by ELISA and other validated methods 3. Quality of life measured by validated questionnaires (SF-12) 4. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire 5. Physical activity measured using the short form of the Minnesota physical activity questionnaire 6. Chronotype measured using the Horne and Östberg questionnaire 7. Cognitive performance measured using some cognitive tests, including TMT-A, TMT-B, COWAT 8. Metabolomic markers measured in plasma depending on additional funding. RNM will be used in a multimarker platform 9. Gene expression: depending on additional funding selected gene-expression or whole transcriptome gene expression will be measured by RT-PCR or whole transcriptome human arrays |
| Overall study start date | 10/10/2019 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Volunteers recruited from the general population 2. Between 25 and 50 years old 3. BMI between 23 and 35 kg/m2 |
| Key exclusion criteria | 1. Diseased 2. Nut allergy or intolerance 3. Immunodeficiency or HIV-positive status 4. Liver cirrhosis or chronic renal failure 5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc 6. Any severe co-morbid condition 7. Alcohol abuse or addition 8. History of major organ transplantation 9. Concurrent therapy with immunosuppressive drugs or cytotoxic agents 10. Current treatment with systemic corticosteroids 11. Current use of weight loss medication 12. Patients with an acute infection or inflammation 13. Any other condition that may interfere with the completion of the study protocol |
| Date of first enrolment | 27/12/2019 |
| Date of final enrolment | 15/04/2020 |
Locations
Countries of recruitment
- Spain
Study participating centres
Valencia
46010
Spain
Pabellon 11
Madrid
28029
Spain
Sponsor information
University/education
Avda. Blasco Ibanes, 15
Valencia
46010
Spain
| Phone | +34 (0)963864417 |
|---|---|
| olga.portoles@uv.es | |
| Website | http://www.uv.es/ |
"ROR" |
https://ror.org/043nxc105 |
Industry
Ctra. Real de Madrid Norte, 81
Beniparrell
46469
Spain
| Phone | +34 (0)961 22 30 00 |
|---|---|
| nsebastia@importaco.com |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Valencia, 85|86
- Location
- Spain
No information available
No information available
Results and Publications
| Intention to publish date | 31/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Findings regarding the main hypothesis will be published in international journals related to nutrition, aging, obesity, cardiovascular risks and epigenetics. Additional publications will include further secondary analyses. Posters and oral communications in related scientific meetings are planned. No additional documents will be publicly available. |
| IPD sharing plan | The data will not be made available because this is indicated in the informed consent signed by the participants. |
Editorial Notes
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
19/12/2019: Trial's existence confirmed by institutional review board of Valencia University (human subjects).
