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NCT Number: NCT05464186

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children

This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.

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Key information

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Balance Foundation Obesity Prevention Center

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Donna L Lesperance, MA, MPH

CONTACT

[email protected]

617-919-7305

About this study

Background The optimal type of milk is a topic of much debate. Several recent observational studies indicate that consuming whole (full-fat), compared to reduced-fat milk, is associated with less weight gain and decreased cardiometabolic disease risk. The observed beneficial effect of consuming whole milk on body weight may be due to its greater satiety value, leading to consumption of fewer calories from other lower quality (e.g., sugary) foods. Mechanistic studies indicate that substitution of carbohydrate with certain saturated fatty acids in milk increases low-density lipoprotein cholesterol (LDL-C). However, this increase has been attributed to large, buoyant particles that are less atherogenic than small, dense particles; is accompanied by an increase in high-density lipoprotein cholesterol (HDL-C); and may not elevate overall risk compared to carbohydrate.

Specific Aims and Hypotheses

  • To examine the effects of milk consumption on body composition (Aim #1) and cardiometabolic disease risk factors (Aim #2). Primary Hypothesis. Consuming whole milk will result in less weight gain compared to consuming nonfat milk. Secondary hypothesis. Consuming whole milk will decrease cardiometabolic disease risk compared to consuming nonfat milk.
  • To explore the effects of milk consumption on dietary quality (Aim #3). Exploratory hypothesis. Consuming whole milk will improve overall dietary quality by displacing lower quality foods compared to consuming nonfat milk, particularly among children with low baseline dietary quality.
  • (Ancillary Study) To evaluate the effects of milk consumption on risk and prevalence of dental caries.

Design Randomized Controlled Trial. Participants (N=200, aged 9 to 12 years, BMI≥75th percentile) will be randomly assigned for 1 year to receive: 1) Whole milk, 3 cups/d or 2) Nonfat milk, 3 cups/d. To promote adherence to the interventions, the investigators will rely on home delivery of milk using methods consistent with previous successful studies.

Study Outcomes The primary outcome is change in fat mass measured by air displacement plethysmography (BodPod) at 3 time points (baseline and 6 and 12 months). To evaluate cardiometabolic disease risk factors, the investigators will obtain a plasma MetaboProfile®(LabCorp) that includes lipoprotein particle sizes and subfraction concentrations, novel measures of insulin-resistant dyslipoproteinemia and inflammation, and a conventional lipid profile. The investigators will also measure blood pressure.

For the Ancillary Study, outcomes include salivary cariogenicity (pH, flow, and buffering capacity); caries prevalence; dietary quality (cariogenic potential); and serum 25-hydroxyvitamin D.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 9 to 12 years
  • BMI ≥75th percentile for sex and age
  • Residence in the Greater Boston catchment area

Exclusion criteria

  • Aversion to nonfat or whole milk
  • Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided)
  • Plans to move away from the Greater Boston catchment area during the study period
  • Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation)
  • Change in body weight exceeding 10% during prior year
  • Recent adherence to a special diet
  • Chronic use of any medication or dietary supplement that could affect study outcomes
  • Another member of the family (first degree relative) or household participating in the study

Treatment and study plan

Whole milk

Behavioral

Weekly home delivery of whole milk, daily text messages, monthly virtual visits

Nonfat milk

Behavioral

Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits

Primary outcomes

  1. Fat mass

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)

Secondary outcomes

  1. Lean body mass

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by air displacement plethysmography (BodPod)

  2. Percent body fat

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by air displacement plethysmography (BodPod)

  3. Height

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Linear growth

  4. Body mass index (BMI)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Weight in kg divided by height in meters squared

  5. Leptin

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    "Satiety" hormone, released by fat cells, measured by ELISA assay

  6. Ghrelin

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    "Hunger" hormone, released primarily in the stomach, measured by ELISA assay

  7. Insulin-like growth factor-1 (IGF-1)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Indicator of growth hormone action, measured by ELISA assay

  8. Insulin-like growth factor-binding protein 3 (IGF-BP3)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by ELISA assay

  9. Lipoprotein insulin resistance (LPIR)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Main outcome for Specific Aim #2; a 6-component weighted score of triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (sum of large and very large TRL-P, large HDL-P, small LDL-P), measured by nuclear magnetic resonance spectroscopy

  10. Triglyceride-rich lipoprotein particle (TRL-P) size

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by nuclear magnetic resonance spectroscopy

  11. High-density lipoprotein particle (HDL-P) size

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by nuclear magnetic resonance spectroscopy

  12. Low-density lipoprotein particle (LDL-P) size

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by nuclear magnetic resonance spectroscopy

  13. Sum of large and very large TRL-P concentration

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by nuclear magnetic resonance spectroscopy

  14. Large HDL-P concentration

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by nuclear magnetic resonance spectroscopy

  15. Small LDL-P concentration

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by nuclear magnetic resonance spectroscopy

  16. Large LDL-P concentration

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by nuclear magnetic resonance spectroscopy

  17. Triglycerides (TG)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Part of conventional lipid profile

  18. High-density lipoprotein cholesterol (HDL-C)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Part of conventional lipid profile

  19. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Part of conventional lipid profile

  20. Glucose

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured enzymatically using hexokinase method

  21. Insulin

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by electrochemiluminescence immunoassay

  22. Insulin resistance

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by homeostasis model assessment (HOMA), using fasting glucose and insulin concentrations

  23. Adiponectin - total and high molecular weight

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Hormone released from fat cells, promotes insulin sensitivity and helps regulate blood glucose, measured by ELISA assay

  24. Hemoglobin A1c (HgA1c)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Marker of blood glucose control, measured using a system based turbidimetric immunoinhibition

  25. High-sensitivity C-reactive protein (hsCRP)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Indicator of chronic inflammation, measured by immunoturbidimetric assay

  26. Interleukin-6 (IL-6)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Protein which stimulates synthesis of hsCRP, measured by ELISA assay

  27. Fibrinogen

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Protein involved in blood clotting, measured by immunoturbidimetric assay

  28. Plasminogen activator inhibitor-1 (PAI-1)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Protein involved in blood clotting, measured by ELISA assay

  29. Systolic blood pressure

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by auscultation

  30. Diastolic blood pressure

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Measured by auscultation

  31. Salivary cariogenicity

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    (Ancillary Study) Risk for dental caries (cavities), measured using the GC Dental America Saliva-Check Buffer Kit (pH, flow, and buffering capacity)

  32. Caries prevalence

    Time frame: Difference between start of trial (time of randomization) and end of trial (12 months)

    (Ancillary Study) Assessed by clinical examination and digital radiograph (x-rays)

  33. Serum 25-hydroxyvitamin D [25(OH)D]

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    (Ancillary Study) Measured by a competitive electrochemiluminescence immunoassay

Other outcomes

  1. Pentadecanoic acid (C15:0)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat

  2. Heptadecanoic acid (C17:0)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat

  3. trans Palmitoleic acid (tC16:1ω-7)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat

  4. Alternative Healthy Eating Index (AHEI)

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Main outcome for Specific Aim #3, calculated using data from 24-hour dietary recalls

  5. Milk intake

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Process outcome, measured by 24-hour dietary recalls

  6. Nutrient profile

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Added sugars, saturated fat, fiber, calcium; measured by 24-hour dietary recalls

  7. Food and beverage intake pattern

    Time frame: Change from start of trial (time of randomization) through end of trial (12 months)

    Vegetables, fruits, legumes, and sugar-sweetened beverages; measured by 24-hour dietary recalls

    (Ancillary Study) Frequency of consuming between-meal-sugar-containing foods or beverages and consumption of foods (grams) with a high cariogenic potential, measured by 24-hour dietary recalls

Study contacts

Contact information is provided by the study sponsor or research team.

Donna L Lesperance, MA, MPH

CONTACT

[email protected]

617-919-7305

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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