New Balance Foundation Obesity Prevention Center
Boston, Massachusetts, 02115, United States
Location status: Recruiting
NCT Number: NCT05464186
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
Interested in participating?
Request Info9 year–12 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
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
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly home delivery of whole milk, daily text messages, monthly virtual visits
Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits
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)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by air displacement plethysmography (BodPod)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by air displacement plethysmography (BodPod)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Linear growth
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
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
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
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
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by ELISA assay
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
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by nuclear magnetic resonance spectroscopy
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by nuclear magnetic resonance spectroscopy
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by nuclear magnetic resonance spectroscopy
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by nuclear magnetic resonance spectroscopy
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by nuclear magnetic resonance spectroscopy
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by nuclear magnetic resonance spectroscopy
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by nuclear magnetic resonance spectroscopy
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Part of conventional lipid profile
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Part of conventional lipid profile
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Part of conventional lipid profile
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured enzymatically using hexokinase method
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by electrochemiluminescence immunoassay
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
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
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
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Indicator of chronic inflammation, measured by immunoturbidimetric assay
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
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
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
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by auscultation
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Measured by auscultation
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)
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)
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
(Ancillary Study) Measured by a competitive electrochemiluminescence immunoassay
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
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
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
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
Time frame: Change from start of trial (time of randomization) through end of trial (12 months)
Process outcome, measured by 24-hour dietary recalls
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
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
Contact information is provided by the study sponsor or research team.
Boston Children's Hospital
Other
Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
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