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| Name | Class |
|---|---|
| Horizon 2020 - European Commission | OTHER |
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The overall aim of the present research program is to determine how a healthy whole-diet approach impacts on cardiometabolic health in adults. With its interdisciplinary approach, the study depicts mechanisms behind disease progression and the impact of healthy dietary patterns on changes in markers of low-grade systemic inflammation together with the exploration of knowledge and attitudes about healthy diets. The study has a preventive character as it targets older adults (65+) without manifest disease.
This two arm randomized-controlled study includes the following groups: Controls and Healthy Diet group.
The study will particularly address the following aspects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | No Intervention | No changes in dietary habits | |
| Healthy Diet | Experimental | Changes in dietary habits only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Diet | Behavioral | Receive counseling to meet guidelines for healthy dietary patterns |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood glucose | Blood glucose (mmol/L) assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States) | Before and after 16 weeks |
| Change in plasma triglycerides | Plasma triglycerides (mmol/L) : assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States) | Before and after 16 weeks |
| Change in high-density lipoprotein cholesterol | high-density lipoprotein cholesterol (mmol/L) : assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States) | Before and after 16 weeks |
| Change in waist circumference | waist circumference (cm) assessed by a steel tape | Before and after 16 weeks |
| Change in diastolic and systolic blood pressure (mmHg) | diastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer | Before and after 16 weeks |
| Change in intake of fruit and vegetable | - Fruit and vegetable intake assessed on a 7 scale-item where the lowest value of 1, indicates an intake less than 1 per month, and 7 an intake of at least 5 servings /day. | Before and after 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fawzi Kadi, PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Örebro | 70182 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32311926 | Derived | Bergens O, Veen J, Montiel-Rojas D, Edholm P, Kadi F, Nilsson A. Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Apr;99(16):e19584. doi: 10.1097/MD.0000000000019584. |
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De-identified individual data on participant characteristics and main study outcomes will be made available on reasonable request when the results are published.
Data are available once the results are published.
Controlled access will be applied as follows:
For secondary users (researchers):
For trial participants:
- Own individual data will be available upon request.
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| D009750 |
| Nutritional and Metabolic Diseases |