Impact of Healthy Diet on Metabolic Health in Men and Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Healthy Diet on Metabolic Health in Men and Women

Conditions
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Healthy Aging, Metabolic Syndrome, Diet, Healthy

Intervention / Treatment
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* Behavioral: Healthy Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controls<br>No changes in dietary habits | |
| Experimental: Healthy Diet<br>Changes in dietary habits only | Behavioral: Healthy Diet<br>* Receive counseling to meet guidelines for healthy dietary patterns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |