Impact of Healthy Diet on Metabolic Health in Men and Women

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: determine food literacy, perceived attitudes and barriers for the adoption of new dietary habits incorporating increased fruit and vegetable intake in adults. explore the effects of a randomized controlled intervention promoting healthy dietary patterns (increased intakes of fruit and vegetable, whole-grain, nuts and low fat dairy products and replacing saturated with unsaturated fats and decreased red meat and salt consumption) for a period of 4 months on components of the metabolic syndrome, a large panel of pro- and anti-inflammatory biomarkers and metabolomic profile in adults. assess the long-term adherence to healthy dietary patterns in adults. provide support for behavioural change and evaluate participants' perception of this support.

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)

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)

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)

- 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.

Inclusion Criteria: 65-70 years not meeting 5 servings of fruit and vegetable per day Waist circumference >80 cm (female) and >88 (male) Exclusion Criteria: Movement disability Diabetes, cardiovascular disease, lung disease, overt disease

De-identified individual data on participant characteristics and main study outcomes will be made available on reasonable request when the results are published.

Controlled access will be applied as follows: For secondary users (researchers): registration and data use agreement are required review of secondary users' qualifications, research proposals and data analysis plans. For trial participants: - Own individual data will be available upon request.

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.