Impact of Healthy Diet on Metabolic Health in Men and Women

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Healthy Aging; Diet, Healthy
• Interventions: Behavioral: Healthy Diet

• Registration Number: NCT04062682
• Lead Sponsor: Örebro University, Sweden

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.

Study Timeline

• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Study Start: 2020-02-17
• Primary Completion: 2021-03-02
• Study Completion: 2021-03-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Diet	Healthy Diet	Changes in dietary habits only

Primary Outcome Measures

Name	Time	Method
Change in blood glucose	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)
Change in plasma triglycerides	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)
Change in high-density lipoprotein cholesterol	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)
Change in waist circumference	Before and after 16 weeks	waist circumference (cm) assessed by a steel tape
Change in diastolic and systolic blood pressure (mmHg)	Before and after 16 weeks	diastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer
Change in intake of fruit and vegetable	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.

Trial Locations

Locations (1)

Örebro University; 🇸🇪 Örebro, Sweden