Eligibility
< 18
All Sexes
What conditions do you have?
Select
Study Summary
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
Eligible Conditions
- Obesity
- Cardiovascular Diseases
- Diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 30 Secondary · Reporting Duration: Change from start of trial (time of randomization) through end of trial (12 months)
Month 12
Adiponectin - total and high molecular weight
Alternative Healthy Eating Index (AHEI)
Body mass index (BMI)
Diastolic blood pressure
Fat mass
Fibrinogen
Food and beverage intake pattern
Ghrelin
Glucose
Height
Hemoglobin A1c (HgA1c)
Heptadecanoic acid (C17:0)
High-density lipoprotein cholesterol (HDL-C)
High-density lipoprotein particle (HDL-P) size
High-sensitivity C-reactive protein (hsCRP)
Insulin
Insulin resistance
Insulin-like growth factor-1 (IGF-1)
Insulin-like growth factor-binding protein 3 (IGF-BP3)
Interleukin-6 (IL-6)
Large HDL-P concentration
Large LDL-P concentration
Lean body mass
Leptin
Lipoprotein insulin resistance (LPIR)
Low-density lipoprotein cholesterol (LDL-C)
Low-density lipoprotein particle (LDL-P) size
Milk intake
Nutrient profile
Pentadecanoic acid (C15:0)
Percent body fat
Plasminogen activator inhibitor-1 (PAI-1)
Small LDL-P concentration
Sum of large and very large TRL-P concentration
Systolic blood pressure
Triglyceride-rich lipoprotein particle (TRL-P) size
Triglycerides (TG)
trans Palmitoleic acid (tC16:1ω-7)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Whole milk
1 of 2
Nonfat milk
1 of 2
Experimental Treatment
200 Total Participants · 2 Treatment Groups
Primary Treatment: Whole milk · No Placebo Group · N/A
Whole milk
Behavioral
Experimental Group · 1 Intervention: Whole milk · Intervention Types: BehavioralNonfat milk
Behavioral
Experimental Group · 1 Intervention: Nonfat milk · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Whole milk
2013
N/A
~30
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from start of trial (time of randomization) through end of trial (12 months)
Closest Location: New Balance Foundation Obesity Prevention Center · Boston, MA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Obesity
0 CompletedClinical Trials
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
704 Previous Clinical Trials
5,310,739 Total Patients Enrolled
21 Trials studying Obesity
5,450 Patients Enrolled for Obesity
Cara B Ebbeling, PhDPrincipal InvestigatorBoston Children's Hospital
9 Previous Clinical Trials
723 Total Patients Enrolled
8 Trials studying Obesity
723 Patients Enrolled for Obesity
David S Ludwig, MD, PhDPrincipal InvestigatorBoston Children's Hospital
15 Previous Clinical Trials
1,104 Total Patients Enrolled
11 Trials studying Obesity
991 Patients Enrolled for Obesity
Eligibility Criteria
Age < 18 · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You consume less than 1.5 cups/d of milk on average.\n
You are a resident of Crescent Ridge.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Ebbeling, Cara B. 2020. “Confusion at the Milk Cooler: Opportunity to Bolster the Evidence Base for Preventive Nutrition”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/nqz319.
- Albala, Cecilia, Cara B Ebbeling, Mariana Cifuentes, Lydia Lera, Nelly Bustos, and David S Ludwig. 2008. “Effects of Replacing the Habitual Consumption of Sugar-sweetened Beverages with Milk in Chilean Children”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/88.3.605.
- Willett, Walter C., and David S. Ludwig. 2020. “Milk and Health”. Edited by Edward W. Campion. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmra1903547.
- Cara B Ebbeling 2022. "Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05464186.
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