Clinical trial NCT04062682: Impact of Healthy Diet on Metabolic Health in Men and Women
Official title: Impact of Healthy Diet on Metabolic Health in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Metabolic Syndrome
Diet, Healthy
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Horizon 2020 - European Commission
First posted: 2019-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in blood glucose
timeFrame: Before and after 16 weeks
measure: Change in plasma triglycerides
timeFrame: Before and after 16 weeks
measure: Change in high-density lipoprotein cholesterol
timeFrame: Before and after 16 weeks
measure: Change in waist circumference
timeFrame: Before and after 16 weeks
measure: Change in diastolic and systolic blood pressure (mmHg)
timeFrame: Before and after 16 weeks
measure: Change in intake of fruit and vegetable
timeFrame: Before and after 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Fawzi Kadi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.