Healthy AgingNCT04062682
Impact of Healthy Diet on Metabolic Health in Men and Women
A study testing Healthy Diet in people with Healthy Aging and Metabolic Syndrome, run by Örebro University, Sweden at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 65 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Metabolic Syndrome, Diet, Healthy
- What is being tested?
- Healthy Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 17 Feb 2020to 2 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 70 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-70 years
- not meeting 5 servings of fruit and vegetable per day
- Waist circumference >80 cm (female) and >88 (male)
Who cannot join
- Movement disability
- Diabetes, cardiovascular disease, lung disease, overt disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Aging, Metabolic Syndrome, Diet, Healthy
- Being tested
- Healthy Diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy DietBehavioural
Receive counseling to meet guidelines for healthy dietary patterns
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | No changes in dietary habits |
| Healthy Diet | Experimental | Changes in dietary habits only Receives: Behavioral: Healthy Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Before and after 16 weeks
Change in waist circumference
waist circumference (cm) assessed by a steel tape
Measured: Before and after 16 weeks
Change in diastolic and systolic blood pressure (mmHg)
diastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer
Measured: 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.
Measured: Before and after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start17 Feb 2020
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Responsible party
- Principal investigator, Fawzi Kadi, Örebro University, Sweden
- Investigators
- Fawzi Kadi, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062682
- Sponsor's protocol ID
- 2017/511
- Status last verified
- Apr 2021
- First submitted
- 14 Aug 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data on participant characteristics and main study outcomes will be made available on reasonable request when the results are published.
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.
PubMed 32311926
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Healthy Diet on Metabolic Health in Men and Women
- ClinicalTrials.gov ID
- NCT04062682
- Acronym / sponsor ID
- 2017/511
- Conditions
- Healthy Aging, Metabolic Syndrome, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –No changes in dietary habits |
| Healthy Diet | Experimental | Behavioral: Healthy DietChanges in dietary habits only |
Who may qualify
- Ages
- 65 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65-70 years
- not meeting 5 servings of fruit and vegetable per day
- Waist circumference >80 cm (female) and >88 (male)
Key exclusion criteria (2 listed)
- Movement disability
- Diabetes, cardiovascular disease, lung disease, overt disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy DietReceive counseling to meet guidelines for healthy dietary patterns | Behavioural | Healthy Diet |
Primary outcome
Change in blood glucose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before and after 16 weeks
waist circumference (cm) assessed by a steel tape
Change in diastolic and systolic blood pressure (mmHg)
Time frame: Before and after 16 weeks
diastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer
Change in intake of fruit and vegetable
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 32311926Bergens 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.
- Individual participant dataSharing planned: Yes. De-identified individual data on participant characteristics and main study outcomes will be made available on reasonable request when the results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fawzi Kadi, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Diet in people with Healthy Aging and Metabolic Syndrome, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose (time frame: Before and after 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.