Clinical trial NCT05464186: Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children
Official title: Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Diabetes
Cardiovascular Diseases
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)
* Abnormal laboratory tests: HgA1c, TSH, hematocrit, BUN, creatinine, ALT (\>1.5 normal upper limit)
* 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

Primary outcomes:
measure: Fat mass
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
Secondary outcomes:
measure: Lean body mass
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Percent body fat
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Height
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Body mass index (BMI)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Leptin
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Ghrelin
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Insulin-like growth factor-1 (IGF-1)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Insulin-like growth factor-binding protein 3 (IGF-BP3)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Lipoprotein insulin resistance (LPIR)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Triglyceride-rich lipoprotein particle (TRL-P) size
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: High-density lipoprotein particle (HDL-P) size
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Low-density lipoprotein particle (LDL-P) size
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Sum of large and very large TRL-P concentration
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Large HDL-P concentration
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Small LDL-P concentration
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Large LDL-P concentration
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Triglycerides (TG)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Glucose
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Insulin
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Insulin resistance
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Adiponectin - total and high molecular weight
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Hemoglobin A1c (HgA1c)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: High-sensitivity C-reactive protein (hsCRP)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Interleukin-6 (IL-6)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Fibrinogen
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Plasminogen activator inhibitor-1 (PAI-1)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Systolic blood pressure
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Diastolic blood pressure
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
Other outcomes:
measure: Pentadecanoic acid (C15:0)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Heptadecanoic acid (C17:0)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: trans Palmitoleic acid (tC16:1ω-7)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Alternative Healthy Eating Index (AHEI)
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Milk intake
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Nutrient profile
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
measure: Food and beverage intake pattern
timeFrame: Change from start of trial (time of randomization) through end of trial (12 months)
Locations:
city: Boston
country: United States
facility: New Balance Foundation Obesity Prevention Center
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Cara B Ebbeling, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: David S Ludwig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.
citation: Ebbeling CB. Confusion at the milk cooler: opportunity to bolster the evidence base for preventive nutrition. Am J Clin Nutr. 2020 Feb 1;111(2):240-241. doi: 10.1093/ajcn/nqz319. No abstract available.
citation: Willett WC, Ludwig DS. Milk and Health. N Engl J Med. 2020 Feb 13;382(7):644-654. doi: 10.1056/NEJMra1903547. No abstract available.