Impact of Healthy Diet on Metabolic Health in Men and Women

Metabolic Syndrome Clinical Trial

Official title:

Impact of Healthy Diet on Metabolic Health in Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062682
• Other study ID #: 2017/511
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: March 2, 2021

Study information

• Verified date: April 2021
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Healthy Aging
• Metabolic Syndrome

Intervention

Behavioral:
• Healthy Diet
Receive counseling to meet guidelines for healthy dietary patterns

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Horizon 2020 - European Commission

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in waist circumference	waist circumference (cm) assessed by a steel tape	Before and after 16 weeks
Primary	Change in diastolic and systolic blood pressure (mmHg)	diastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer	Before and after 16 weeks
Primary	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