DGA Mediterranean diet pattern, energy balance for Obesity
Phase-Based Progress Estimates
Effectiveness
Safety
Obesity+1 More
DGA Mediterranean diet pattern, energy balance - OtherEligibility
18 - 65
Female
What conditions do you have?
Select
Eligibility
18 - 65
Female
What conditions do you have?
Select
Study Summary
This trial will test whether weight loss is the most important factor in promoting better health, or if it is more important to focus on eating a healthy diet.
Eligible Conditions
- Obesity
- Body Weight
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 72 Secondary · Reporting Duration: Measured weekly for weeks 0 through 14, and weeks 17, 21, 25, 29 and 32
Hour 6
Change in post-prandial metabolic rate
Hour 2
Change in Matsuda Index
Hour 6
Change in ghrelin in response to a meal
Change in insulin in response to a meal
Change in leptin in response to a meal
Change in triglycerides in response to a meal
Week 17
Change in body mass index
Change in body weight
Week 0
Barriers to physical activity
Eating behavior
Genetic Risk of Obesity
Height
Power of food scale
Three factor eating inventory
Trier inventory of chronic stress
Usual physical activity
Wheaton chronic stress scale
Week 0
Change in self-efficacy
Week 0
Change in diet satisfaction
Changes in dietary intake
Week 0
Change in continuous diastolic blood pressure
Change in continuous systolic blood pressure
Change in liver fat
Change in liver stiffness
Change in mean arterial blood pressure
Change in muscular strength output
Change in resting metabolic rate
Change in stress reactivity
Week 0
Change in perceived stress
Week 0, 5, 14
Change in mood
Week 0
Change in fecal microbiome
Week 0
Change in C-reactive protein
Change in allostatic load
Change in body water (via InBody)
Change in fasting blood glucose
Change in hemoglobin A1C
Change in hip circumference
Change in red blood cell fatty acids
Change in resting diastolic blood pressure
Change in resting heart rate
Change in resting systolic blood pressure
Change in waist circumference
Change in waist to hip ratio
Week 0
Change in interstitial glucose levels
Week 14
Diet acceptability
Week 32
Focus group
Week 5
Food craving inventory
Yale Food Addiction Scale
Week 5 an 14
Change in attentive function
Week 5 and 14
Change in Food Choice
Change in appetite
Body Weight Changes
Change in carotenoid levels
Change in executive function
Change in extracellular acidification rate (ECAR)
Heart rate
Change in high density lipoprotein (HDL) cholesterol
Change in low density lipoprotein (LDL) cholesterol
Change in metabolic flexibility
Change in multitasking
Oxygen
Change in psycho-motor speed
Change in response speed
Change in social cognition
Change in spatial memory
Change in total cholesterol
Change in verbal memory
Week 5
Change in body fat (via DEXA scan)
Change in predicted VO2 max
Week 5
Change in vascular health
Week 5
Change in urinary nitrogen
Change in urinary potassium
Change in urinary sodium
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
DGA Mediterranean diet pattern, energy balance
1 of 3
DGA Mediterranean diet pattern, negative energy balance
1 of 3
TAD diet pattern
1 of 3
Experimental Treatment
168 Total Participants · 3 Treatment Groups
Primary Treatment: DGA Mediterranean diet pattern, energy balance · No Placebo Group · N/A
DGA Mediterranean diet pattern, energy balance
Other
Experimental Group · 1 Intervention: DGA Mediterranean diet pattern, energy balance · Intervention Types: OtherDGA Mediterranean diet pattern, negative energy balance
Other
Experimental Group · 1 Intervention: DGA Mediterranean diet pattern, negative energy balance · Intervention Types: OtherTAD diet pattern
Other
Experimental Group · 1 Intervention: TAD diet pattern, negative energy balance · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured weekly for weeks 0 through 14, and weeks 17, 21, 25, 29 and 32
Who is running the clinical trial?
USDA, Western Human Nutrition Research CenterLead Sponsor
58 Previous Clinical Trials
10,850 Total Patients Enrolled
14 Trials studying Obesity
911 Patients Enrolled for Obesity
Kevin D Laugero, PhDPrincipal InvestigatorUSDA, Western Human Nutrition Research Center
Eligibility Criteria
Age 18 - 65 · Female Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are willing to have a blood sample taken.
You have a body mass index (BMI) of 27-39.
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.
Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| UC Davis, Western Human Nutrition Research Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- UC Davis, Western Human Nutrition Research Center: < 48 hours
Typically responds via
| Phone Call | 100.0% |
References
- Krishnan, Sridevi, Sean H Adams, Lindsay H Allen, Kevin D Laugero, John W Newman, Charles B Stephensen, Dustin J Burnett, et al.. 2018. “A Randomized Controlled-feeding Trial Based on the Dietary Guidelines for Americans on Cardiometabolic Health Indexes”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/nqy113.
- Krishnan, Sridevi, Sean H Adams, Lindsay H Allen, Kevin D Laugero, John W Newman, Charles B Stephensen, Dustin J Burnett, et al.. 2018. “A Randomized Controlled-feeding Trial Based on the Dietary Guidelines for Americans on Cardiometabolic Health Indexes”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/nqy113.
- 2022. "Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04293224.
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