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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464186
• Other study ID #: IRB-P00041990
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Boston Children's Hospital
• Contact: Donna L Lesperance, MA, MPH
• Phone: 617-919-7305
• Email: Donna.Lesperance[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Obesity

Intervention

Behavioral:
• Whole milk
Weekly home delivery of whole milk, daily text messages, monthly virtual visits
• Nonfat milk
Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits

Locations

Country	Name	City	State
United States	New Balance Foundation Obesity Prevention Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pentadecanoic acid (C15:0)	Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat	Change from start of trial (time of randomization) through end of trial (12 months)
Other	Heptadecanoic acid (C17:0)	Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat	Change from start of trial (time of randomization) through end of trial (12 months)
Other	trans Palmitoleic acid (tC16:1?-7)	Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat	Change from start of trial (time of randomization) through end of trial (12 months)
Other	Alternative Healthy Eating Index (AHEI)	Main outcome for Specific Aim #3, calculated using data from 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)
Other	Milk intake	Process outcome, measured by 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)
Other	Nutrient profile	Added sugars, saturated fat, fiber, calcium; measured by 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)
Other	Food and beverage intake pattern	Vegetables, fruits, legumes, and sugar-sweetened beverages; measured by 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)
Primary	Fat mass	Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Lean body mass	Measured by air displacement plethysmography (BodPod)	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Percent body fat	Measured by air displacement plethysmography (BodPod)	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Height	Linear growth	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Body mass index (BMI)	Weight in kg divided by height in meters squared	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Leptin	"Satiety" hormone, released by fat cells, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Ghrelin	"Hunger" hormone, released primarily in the stomach, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Insulin-like growth factor-1 (IGF-1)	Indicator of growth hormone action, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Insulin-like growth factor-binding protein 3 (IGF-BP3)	Measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Lipoprotein insulin resistance (LPIR)	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	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Triglyceride-rich lipoprotein particle (TRL-P) size	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	High-density lipoprotein particle (HDL-P) size	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Low-density lipoprotein particle (LDL-P) size	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Sum of large and very large TRL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Large HDL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Small LDL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Large LDL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Triglycerides (TG)	Part of conventional lipid profile	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	High-density lipoprotein cholesterol (HDL-C)	Part of conventional lipid profile	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Low-density lipoprotein cholesterol (LDL-C)	Part of conventional lipid profile	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Glucose	Measured enzymatically using hexokinase method	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Insulin	Measured by electrochemiluminescence immunoassay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Insulin resistance	Measured by homeostasis model assessment (HOMA), using fasting glucose and insulin concentrations	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Adiponectin - total and high molecular weight	Hormone released from fat cells, promotes insulin sensitivity and helps regulate blood glucose, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Hemoglobin A1c (HgA1c)	Marker of blood glucose control, measured using a system based turbidimetric immunoinhibition	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	High-sensitivity C-reactive protein (hsCRP)	Indicator of chronic inflammation, measured by immunoturbidimetric assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Interleukin-6 (IL-6)	Protein which stimulates synthesis of hsCRP, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Fibrinogen	Protein involved in blood clotting, measured by immunoturbidimetric assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Plasminogen activator inhibitor-1 (PAI-1)	Protein involved in blood clotting, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Systolic blood pressure	Measured by auscultation	Change from start of trial (time of randomization) through end of trial (12 months)
Secondary	Diastolic blood pressure	Measured by auscultation	Change from start of trial (time of randomization) through end of trial (12 months)