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AtherosclerosisPhase 3NCT00223600

Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)

A Phase 3 study testing Nutritional and life style counseling in people with Atherosclerosis, run by University of Turku at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk… Read more about this study

Who is it for?
Ages 7 to 7 monthsHealthy volunteers can take part
Conditions the study is for
Atherosclerosis
What is being tested?
Nutritional and life style counseling
How many people
1,062 participants
Where
1 siteFinland
Study dates
May 1990to Aug 2005
Phase
Phase 3
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 7 to 7 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • children at the age of 7 months and their families, recruited from the general population

Who cannot join

  • severe sickness

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Department of Pediatrics, University of Turku

    Turku, FI-20520

Other trials in Finland

About this study

1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk factors. The controls children receive information as given at the well-baby clinics and in school health care of children and adolescents. The hypothesis is that the intervention children have healthier food habits and serum serum lipid and lipoprotein concentrations than the controls, fewer of them start smoking, and their physical activity level is higher than that of the controls.

Read the detailed description

1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk factors. The controls children receive information as given at the well-baby clinics and in school health care of children and adolescents. The hypothesis is that the intervention children have healthier food habits and serum serum lipid and lipoprotein concentrations than the controls, fewer of them start smoking, and their physical activity level is higher than that of the controls. We further hypothesised that the life-style intervention had no adverse mental or somatic effects on the children. Intima-media thickness of the carotid and brachial arterias and aorta and vasodilatation of the brachial artery induced by endogenous NO production have been also been measures at 2-year intervals since the age of 11 years. Recruitment to the study began in 1990 and continued for 2 years. The children are now between 14 and 16 years of age. 550 children remain in the study, which will continue until the last children have reached the age of 20 years.

Conditions
Atherosclerosis
Being tested
Nutritional and life style counseling
Keywords
lipids, lipoproproteins, growth, neurological development, vascular wall, blood pressure, nutrient intake
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional and life style counselingBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intake of nutrients

  2. Serum lipid and lipoprotein concentrations

  3. Growth and development

  4. Smoking

  5. Physical activity level and fitness

  6. Intima-media thickness of arteries and rate of NO-induced vasodilatation

Secondary outcomes (1)

  1. Psychological burden caused by the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startMay 1990
  3. Study completionAug 2005

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,062 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00223600
Sponsor's protocol ID
STRIP19902010
Other IDs
Academy of Finland (grant)
Status last verified
Aug 2005
First submitted
13 Sep 2005
Last updated
19 Sep 2006
Results posted
No

Publications

  • Angle S, Keskinen S, Lapinleimu H, Helenius H, Raittinen P, Ronnemaa T, Simell O. Weight gain since infancy and prepubertal body dissatisfaction. Arch Pediatr Adolesc Med. 2005 Jun;159(6):567-71. doi: 10.1001/archpedi.159.6.567.

    PubMed 15939857

  • Viikari JS, Niinikoski H, Juonala M, Raitakari OT, Lagstrom H, Kaitosaari T, Ronnemaa T, Simell O. Risk factors for coronary heart disease in children and young adults. Acta Paediatr Suppl. 2004 Dec;93(446):34-42. doi: 10.1111/j.1651-2227.2004.tb00237.x.

    PubMed 15702668

  • Volanen I, Raitakari OT, Vainionpaa R, Arffman M, Aarnisalo J, Angle S, Kallio K, Simell O. Serum lipid profiles poorly correlate with Chlamydia pneumoniae, Helicobacter pylori, and cytomegalovirus seropositivity in prospectively followed-up healthy children. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):827-32. doi: 10.1161/01.ATV.0000158382.50942.6a. Epub 2005 Feb 3.

    PubMed 15692096

  • Hakanen M, Ronnemaa T, Talvia S, Rask-Nissila L, Koulu M, Viikari J, Bergendahl M, Simell O. Serum leptin concentration poorly reflects growth and energy and nutrient intake in young children. Pediatrics. 2004 May;113(5):1273-8. doi: 10.1542/peds.113.5.1273.

    PubMed 15121941

  • Ruottinen S, Karjalainen S, Pienihakkinen K, Lagstrom H, Niinikoski H, Salminen M, Ronnemaa T, Simell O. Sucrose intake since infancy and dental health in 10-year-old children. Caries Res. 2004 Mar-Apr;38(2):142-8. doi: 10.1159/000075938.

    PubMed 14767171

  • Viinikainen J, Heineck G, Bockerman P, Pahkala K, Jula A, Kari JT, Lagstrom H, Niinikoski H, Pehkonen J, Rovio SP, Ronnemaa T, Salo P, Viikari J, Raitakari O. Participation in a 20-Year Randomized Dietary Trial and University Enrollment. Health Sci Rep. 2026 Apr 19;9(4):e72359. doi: 10.1002/hsr2.72359. eCollection 2026 Apr.

    PubMed 42011282

  • Heiskanen MA, Aatsinki A, Hakonen P, Kartiosuo N, Munukka E, Lahti L, Keskitalo A, Huovinen P, Niinikoski H, Viikari J, Ronnemaa T, Lagstrom H, Jula A, Raitakari O, Rovio SP, Pahkala K. Association of Long-Term Habitual Dietary Fiber Intake since Infancy with Gut Microbiota Composition in Young Adulthood. J Nutr. 2024 Feb;154(2):744-754. doi: 10.1016/j.tjnut.2024.01.008. Epub 2024 Jan 12.

    PubMed 38219864

  • Laitinen TT, Saha E, Pahkala K, Kartiosuo N, Nuotio J, Lagstrom H, Viikari J, Ronnemaa T, Jula A, Raitakari O, Niinikoski H. Associations of breastfeeding duration with serum lipid values from infancy until age 20 years - the STRIP study. Scand J Public Health. 2024 Aug;52(6):685-691. doi: 10.1177/14034948231183030. Epub 2023 Jun 30.

    PubMed 37387272

  • Laitinen TT, Nuotio J, Niinikoski H, Juonala M, Rovio SP, Viikari JSA, Ronnemaa T, Magnussen CG, Sabin M, Burgner D, Jokinen E, Lagstrom H, Jula A, Simell O, Raitakari OT, Pahkala K. Attainment of Targets of the 20-Year Infancy-Onset Dietary Intervention and Blood Pressure Across Childhood and Young Adulthood: The Special Turku Coronary Risk Factor Intervention Project (STRIP). Hypertension. 2020 Nov;76(5):1572-1579. doi: 10.1161/HYPERTENSIONAHA.120.15075. Epub 2020 Sep 14.

    PubMed 32921196

  • Laitinen TT, Nuotio J, Rovio SP, Niinikoski H, Juonala M, Magnussen CG, Jokinen E, Lagstrom H, Jula A, Viikari JSA, Ronnemaa T, Simell O, Raitakari OT, Pahkala K. Dietary Fats and Atherosclerosis From Childhood to Adulthood. Pediatrics. 2020 Apr;145(4):e20192786. doi: 10.1542/peds.2019-2786. Epub 2020 Mar 24.

    PubMed 32209700

  • Laitinen TT, Nuotio J, Juonala M, Niinikoski H, Rovio S, Viikari JSA, Ronnemaa T, Magnussen CG, Jokinen E, Lagstrom H, Jula A, Simell O, Raitakari OT, Pahkala K. Success in Achieving the Targets of the 20-Year Infancy-Onset Dietary Intervention: Association With Insulin Sensitivity and Serum Lipids. Diabetes Care. 2018 Oct;41(10):2236-2244. doi: 10.2337/dc18-0869. Epub 2018 Aug 2.

    PubMed 30072407

  • Lehtovirta M, Pahkala K, Niinikoski H, Kangas AJ, Soininen P, Lagstrom H, Viikari JSA, Ronnemaa T, Jula A, Ala-Korpela M, Wurtz P, Raitakari OT. Effect of Dietary Counseling on a Comprehensive Metabolic Profile from Childhood to Adulthood. J Pediatr. 2018 Apr;195:190-198.e3. doi: 10.1016/j.jpeds.2017.11.057. Epub 2018 Feb 1.

    PubMed 29397160

  • Jaakkola JM, Pahkala K, Ronnemaa T, Viikari J, Niinikoski H, Jokinen E, Lagstrom H, Jula A, Raitakari O. Longitudinal child-oriented dietary intervention: Association with parental diet and cardio-metabolic risk factors. The Special Turku Coronary Risk Factor Intervention Project. Eur J Prev Cardiol. 2017 Nov;24(16):1779-1787. doi: 10.1177/2047487317720286. Epub 2017 Jul 20.

    PubMed 28727955

  • Mikola H, Pahkala K, Niinikoski H, Ronnemaa T, Viikari JSA, Jula A, Juonala M, Raitakari OT. Cardiometabolic Determinants of Carotid and Aortic Distensibility From Childhood to Early Adulthood. Hypertension. 2017 Aug;70(2):452-460. doi: 10.1161/HYPERTENSIONAHA.117.09027. Epub 2017 Jun 26.

    PubMed 28652463

  • Jaasaari P, Tolvanen M, Niinikoski H, Karjalainen S. Advanced dental maturity of Finnish 6- to 12-yr-old children is associated with high energy intake. Eur J Oral Sci. 2016 Oct;124(5):465-471. doi: 10.1111/eos.12292. Epub 2016 Sep 20.

    PubMed 27644174

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nutritional and life style counseling in people with Atherosclerosis, run by University of Turku at 1 site in Finland.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2006. 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 Finland. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Intake of nutrients. 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 NCT00223600, which also lists 34 linked publications.

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 19 Sep 2006.

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