Obesity, Diabetes, Cardiovascular Diseases
Conditions
Brief summary
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
Detailed description
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.
Interventions
BEHAVIORALWhole milk
Weekly home delivery of whole milk, daily text messages, monthly virtual visits
BEHAVIORALNonfat milk
Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomly assigned for 1 year to receive home delivery of: 1) Whole milk, 3 cups a day or 2) Nonfat milk, 3 cups a day.
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | 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
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by auscultation |
| Interleukin-6 (IL-6) | Change from start of trial (time of randomization) through end of trial (12 months) | Protein which stimulates synthesis of hsCRP, measured by ELISA assay |
| Fibrinogen | Change from start of trial (time of randomization) through end of trial (12 months) | Protein involved in blood clotting, measured by immunoturbidimetric assay |
| Plasminogen activator inhibitor-1 (PAI-1) | Change from start of trial (time of randomization) through end of trial (12 months) | Protein involved in blood clotting, measured by ELISA assay |
| Diastolic blood pressure | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by auscultation |
| Salivary cariogenicity | 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) |
| Caries prevalence | 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) |
| Serum 25-hydroxyvitamin D [25(OH)D] | Change from start of trial (time of randomization) through end of trial (12 months) | (Ancillary Study) Measured by a competitive electrochemiluminescence immunoassay |
| Lean body mass | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by air displacement plethysmography (BodPod) |
| Percent body fat | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by air displacement plethysmography (BodPod) |
| Height | Change from start of trial (time of randomization) through end of trial (12 months) | Linear growth |
| Body mass index (BMI) | Change from start of trial (time of randomization) through end of trial (12 months) | Weight in kg divided by height in meters squared |
| Leptin | Change from start of trial (time of randomization) through end of trial (12 months) | Satiety hormone, released by fat cells, measured by ELISA assay |
| Ghrelin | 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 |
| Insulin-like growth factor-1 (IGF-1) | Change from start of trial (time of randomization) through end of trial (12 months) | Indicator of growth hormone action, measured by ELISA assay |
| Insulin-like growth factor-binding protein 3 (IGF-BP3) | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by ELISA assay |
| Lipoprotein insulin resistance (LPIR) | 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 |
| Triglyceride-rich lipoprotein particle (TRL-P) size | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by nuclear magnetic resonance spectroscopy |
| High-density lipoprotein particle (HDL-P) size | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by nuclear magnetic resonance spectroscopy |
| Low-density lipoprotein particle (LDL-P) size | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by nuclear magnetic resonance spectroscopy |
| Sum of large and very large TRL-P concentration | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by nuclear magnetic resonance spectroscopy |
| Large HDL-P concentration | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by nuclear magnetic resonance spectroscopy |
| Small LDL-P concentration | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by nuclear magnetic resonance spectroscopy |
| Large LDL-P concentration | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by nuclear magnetic resonance spectroscopy |
| Triglycerides (TG) | Change from start of trial (time of randomization) through end of trial (12 months) | Part of conventional lipid profile |
| High-density lipoprotein cholesterol (HDL-C) | Change from start of trial (time of randomization) through end of trial (12 months) | Part of conventional lipid profile |
| Low-density lipoprotein cholesterol (LDL-C) | Change from start of trial (time of randomization) through end of trial (12 months) | Part of conventional lipid profile |
| Glucose | Change from start of trial (time of randomization) through end of trial (12 months) | Measured enzymatically using hexokinase method |
| Insulin | Change from start of trial (time of randomization) through end of trial (12 months) | Measured by electrochemiluminescence immunoassay |
| Insulin resistance | 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 |
| Adiponectin - total and high molecular weight | 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 |
| Hemoglobin A1c (HgA1c) | 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 |
| High-sensitivity C-reactive protein (hsCRP) | Change from start of trial (time of randomization) through end of trial (12 months) | Indicator of chronic inflammation, measured by immunoturbidimetric assay |
Other
| Measure | Time frame | Description |
|---|---|---|
| trans Palmitoleic acid (tC16:1ω-7) | 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 |
| Alternative Healthy Eating Index (AHEI) | 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 |
| Milk intake | Change from start of trial (time of randomization) through end of trial (12 months) | Process outcome, measured by 24-hour dietary recalls |
| Nutrient profile | 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 |
| Food and beverage intake pattern | 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 |
| Pentadecanoic acid (C15:0) | 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 |
| Heptadecanoic acid (C17:0) | 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 |
Countries
United States
Contacts
Primary ContactDonna L Lesperance, MA, MPH
Outcome results
None listed