Impact of Healthy Diet on Metabolic Health in Men and Women

NCT ID: NCT04062682

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2021-03-02

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.

Conditions

Healthy Aging; Metabolic Syndrome; Diet, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Controls

No changes in dietary habits

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Diet

Changes in dietary habits only

Group Type: EXPERIMENTAL

Healthy Diet

Intervention Type: BEHAVIORAL

Receive counseling to meet guidelines for healthy dietary patterns

Interventions

Healthy Diet

Receive counseling to meet guidelines for healthy dietary patterns

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Horizon 2020 - European Commission

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Fawzi Kadi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fawzi Kadi, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Örebro University

Örebro, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 32311926 (View on PubMed)

Other Identifiers

2017/511

Identifier Type: -

Identifier Source: org_study_id