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Completed

NCT Number: NCT04062682

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.

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Key information

Conditions

Healthy Aging Diet, Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

65 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, 70182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Diet

Behavioral

Receive counseling to meet guidelines for healthy dietary patterns

Primary outcomes

  1. Change in blood glucose

    Time frame: Before and after 16 weeks

    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)

  2. Change in plasma triglycerides

    Time frame: Before and after 16 weeks

    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)

  3. Change in high-density lipoprotein cholesterol

    Time frame: Before and after 16 weeks

    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)

  4. Change in waist circumference

    Time frame: Before and after 16 weeks

    waist circumference (cm) assessed by a steel tape

  5. Change in diastolic and systolic blood pressure (mmHg)

    Time frame: Before and after 16 weeks

    diastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer

  6. Change in intake of fruit and vegetable

    Time frame: Before and after 16 weeks

    • 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.

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Horizon 2020 - European Commission

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2019
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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