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Impact of Healthy Diet on Metabolic Health in Men and Women

Impact of Healthy Diet on Metabolic Health in Men and Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04062682
Enrollment
80
Registered
2019-08-20
Start date
2020-02-17
Completion date
2021-03-02
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy, Healthy Aging, Metabolic Syndrome

Brief summary

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

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.

Interventions

BEHAVIORALHealthy Diet

Receive counseling to meet guidelines for healthy dietary patterns

Sponsors

Horizon 2020 - European Commission
CollaboratorOTHER
Örebro University, Sweden
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood glucoseBefore and after 16 weeksBlood glucose (mmol/L) assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Change in plasma triglyceridesBefore and after 16 weeksPlasma triglycerides (mmol/L) : assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Change in high-density lipoprotein cholesterolBefore and after 16 weekshigh-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)
Change in waist circumferenceBefore and after 16 weekswaist circumference (cm) assessed by a steel tape
Change in diastolic and systolic blood pressure (mmHg)Before and after 16 weeksdiastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer
Change in intake of fruit and vegetableBefore 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026