Impact of Healthy Diet on Metabolic Health in Men and Women

NCT04062682 | Completed

• 1 other identifier: 2017/511
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging; Metabolic Syndrome; Diet, Healthy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Controls

NO INTERVENTION

No changes in dietary habits

Healthy Diet

EXPERIMENTAL

Changes in dietary habits only

Behavioral: Healthy Diet

Interventions

Healthy Diet BEHAVIORAL

Receive counseling to meet guidelines for healthy dietary patterns

Healthy Diet

Eligibility Criteria

• Age: 65 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years
• not meeting 5 servings of fruit and vegetable per day
• Waist circumference \>80 cm (female) and \>88 (male)

You may not qualify if:

• Movement disability
• Diabetes, cardiovascular disease, lung disease, overt disease

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

Örebro University

Örebro, 70182, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32311926 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Fawzi Kadi, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 20, 2019
• Study Start: February 17, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data are available once the results are published.
• 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.

Locations

SE (1)