Dietary Intervention Study in Children (DISC)

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Accession Number

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period

NHLBI Division

Dataset(s) Last Updated
January 24, 2024

Related Studies


Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Commercial Use Specimen Restrictions No

Non-Genetic Use Specimen Restrictions Based On Area Of Use No

Genetic Use Of Specimens Allowed? Yes

Genetic Use Area Of Research Restrictions No

Specific Consent Restrictions

Available Data

Data available for request include DISC main study data as well as hormone and metabolomics data.


The Dietary Intervention Study in Children (DISC) trial was initiated in 1987 and sought to evaluate the efficacy and safety of a lipid lowering diet in 8 to 10 year old children after at least 3 years of followup. The primary efficacy outcome was low-density lipoprotein (LDL) cholesterol. Secondary efficacy outcomes were total cholesterol, high-density lipoprotein (HDL), cholesterol, and triglycerides. Primary safety outcomes were height and serum ferritin. Secondary safety outcomes included serum zinc, folate, retinol, and albumin. The trial was extended, with continuation of the intervention, albeit at a diminished intensity, to follow the children for an additional 4 years, resulting in a mean of 7.4 years of total follow-up, when the participants were on average 17 years old.


A growing body of evidence suggests that atherosclerosis is a long term process that may begin early in childhood. Autopsy studies have revealed coronary fatty streaks in obese children, and other studies have shown that blood cholesterol levels show a fairly high correlation as children age into young adults. Familial clustering of lipid levels provide further rationale for intervention studies aimed at reducing cholesterol levels in children. Previous studies have demonstrated the efficacy of dietary interventions in adults in reducing blood cholesterol levels; however, the safety and efficacy of dietary interventions in growing children were less clear, and previous studies were only short-term interventions.


The DISC study was a multicenter, randomized controlled trial that enrolled 663 prepubertal children aged 8 to 10 years who had elevated LDL-cholesterol levels (80th-98th percentile based on age-gender distributions from the Lipid Research Clinics). The children were assigned at random to an intervention or usual care group. Fifty-five percent of the participants were male. The intervention group attended a series of group and individual sessions where the children and their families were counseled to follow a diet containing 28 percent of calories as total fat, less than 8 percent of calories from saturated fat, dietary cholesterol intake less than 75 mg/1000 kcal, and up to 9% of calories from polyunsaturated fat. The diets were designed to meet nutritional requirements of growing children. The usual care group was provided a packet of educational publications on heart-healthy eating that were generally available to the public. The primary endpoint was change in LDL-cholesterol after three years of followup, and subsequently after 7 years of follow-up.


After three years of followup, LDL cholesterol decreased by an average of 15.4 mg/dL in the intervention group and 11.9 mg/dL in the usual care group. This difference of 3.3 mg/dL (adjusted for baseline levels and gender) was significant (p=0.02). There were no significant differences between the two groups in adjusted mean height or serum ferritin. There were no significant differences in secondary safety measures as well. (JAMA, 1995; 273(18):1429-35). After 7 years of followup, the difference in LDL-cholesterol between the two treatment groups decreased to 2.0 mg/dL, which was no longer significant. There continued to be no significant differences in an adverse direction in primary or secondary safety measures. (Pediatrics, 2001;107(2):256-264).

Additional Details


Intervention: 334

Usual care: 329

 InterventionUsual CareAll
 InterventionUsual CareAll
 InterventionUsual CareAll

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

Visits (Vials):


Screening Visit 1976976
Screening Visit 21,7561,756
Intervention Visit254254
Month 6276276
Month 121,4171,417
Month 2711
Month 363,6023,602
Month 371,7791,779
Month 48542542
Year 51,8581,858
Year 644
Year 71,1281,128
Final Visit 13,2633,263
Final Visit 2 (Repeat)9191
Visits (Subjects):


Total number of subjectsAverage volume (ml) per subject
Screening Visit 14081.42
Screening Visit 26381.53
Intervention Visit836.08
Month 61051.19
Month 125071.33
Month 2712.00
Month 365996.77
Month 374722.22
Month 48873.74
Year 54462.53
Year 616.10
Year 72293.40
Final Visit 15543.91
Final Visit 2 (Repeat)451.08

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Resources Available

Specimens and Study Datasets

Materials Available

Study Documents

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