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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Healthy Aging; Diet, Healthy
• Intervention / Treatment: Behavioral: Healthy Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70182
    • Örebro University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 70 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controls; No changes in dietary habits
Experimental: Healthy Diet; Changes in dietary habits only	Behavioral: Healthy Diet; Receive counseling to meet guidelines for healthy dietary patterns

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Horizon 2020 - European Commission
• Investigators: Principal Investigator: Fawzi Kadi, PhD, Örebro University, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 2017/511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual data on participant characteristics and main study outcomes will be made available on reasonable request when the results are published.
• IPD Sharing Time Frame: Data are available once the results are published.

IPD Sharing Access Criteria

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.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No