Study on the effects of fruit, vegetable, and omega-3 intake on cardiovascular health in older adults
Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Cardiovascular Health and Low-grade Inflammation in the Elderly
This study is testing whether eating more fruits, vegetables, and omega-3s can improve heart health and reduce inflammation in postmenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | Green Beat Academic / other |
| Locations | 2 sites (Graz and 1 other locations) |
| Trial ID | NCT04763291 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of increased fruit, vegetable, and omega-3 fatty acid consumption on cardiovascular health and inflammation in postmenopausal women. Participants will consume Juice Plus+ Fruit, Vegetable and Berry blends, along with Juice Plus+ Omega blend, while adhering to a specific dietary regimen. The study aims to assess improvements in blood pressure, platelet function, and vascular reactivity, which are linked to reduced cardiac risk. The research is based on previous findings that suggest a strong relationship between diet and cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged between 55 and 80 who have a BMI between 18.5 and 40 and consume limited servings of fruits and vegetables.
Not a fit: Patients with significant hypertension, diabetes, autoimmune diseases, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that significantly improve cardiovascular health and reduce inflammation in older adults.
How similar studies have performed: Previous studies have shown positive outcomes with dietary interventions focusing on fruit, vegetable, and omega-3 intake, suggesting that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Post menopausal * Non-smokers * BMI 18.5 to 40 kg/m2 * Vegetable intake ≤ 2 servings/ day * Intake of fruits ≤ 2 servings /day * Adherence to a 6-week washout period for dietary supplements not ingested for specific medical conditions. Exclusion Criteria: * Age \<55 and \>80 years * Smokers (or ex-smokers who quit smoking less than 3 years ago) * Aversion to stop the intake of multivitamins, multiminerals or omega fatty acid supplements * Subjects with histamine intolerance * Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure \> 160mmHg, diastolic blood pressure \>100 mmHg * All medication taken for less than 3 months or with changes on the dosage over the last 3 months and medication for any of the conditions listed below. * Clinically relevant infectious diseases * Diabetes mellitus type I and type II * Rheumatic diseases * Auto-immune diseases * Any stents and coronary artery diseases (CAD) * Cancer patients * Pregnancy * Significant lifestyle changes, e.g. changes in diet or physical activity profile
Where this trial is running
Graz and 1 other locations
- Green Beat — Graz, Austria (Recruiting)
- Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz — Graz, Austria (Not_yet_recruiting)
Study contacts
- Principal investigator: Manfred Lamprecht, PhD — Green Beat
- Study coordinator: Manfred Lamprecht, PhD
- Email: manfred.lamprecht@greenbeat.at
- Phone: +43 664 1328287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.