Effects of Mixed Nut Consumption on Satiety and Weight Management
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mee Young Hong
- Phone Number: 619-594-2392
- Email: mhong2@mail.sdsu.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92182-7251
- Recruiting
- School of Exercise and Nutritional Sciences, SDSU
-
Contact:
- Mee Young Hong
- Phone Number: 619-594-2392
- Email: mhong2@mail.sdsu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-55 years old
- BMI 27-40
Exclusion Criteria:
- Smoker
- Pregnant woman
- Required dietary supplement use
- Required medication of metabolic disorders
- Allergy to nuts or gluten
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Pretzels
|
Subjects consume 240 kcal of pretzels daily for 16 weeks.
|
|
Experimental: Mixed nuts
|
Subjects consume 240 kcal of mixed nuts daily for 16 weeks.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Satiety
Time Frame: 0, 20, 40, 60, 90 and 120 minutes post snack consumption
|
Hunger feeling (appetite) will be examined using visual analog scale (0-10): 0 least and 10 greatest
|
0, 20, 40, 60, 90 and 120 minutes post snack consumption
|
|
Change of glucose level
Time Frame: Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption
|
Glucose level will be examined using glucose analysis
|
Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption
|
|
Change of insulin level
Time Frame: Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption
|
Insulin level will be examined using an ELISA biochemical method
|
Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption
|
|
Change of cholesterol levels
Time Frame: 8 weeks and 16 weeks post daily consumption
|
Cholesterol levels will be examined using a biochemical method
|
8 weeks and 16 weeks post daily consumption
|
|
Change of Lp(a)
Time Frame: 8 weeks and 16 weeks post daily consumption
|
Lp(a) levels will be examined using an ELISA biochemical method
|
8 weeks and 16 weeks post daily consumption
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of microbiome
Time Frame: 8 weeks and 16 weeks post daily consumption
|
Diversity of microbiome will be analyzed in fecal samples
|
8 weeks and 16 weeks post daily consumption
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Nora CL, Zhang L, Castro RJ, Marx A, Carman HB, Lum T, Tsimikas S, Hong MY. Effects of mixed nut consumption on LDL cholesterol, lipoprotein(a), and other cardiometabolic risk factors in overweight and obese adults. Nutr Metab Cardiovasc Dis. 2023 Aug;33(8):1529-1538. doi: 10.1016/j.numecd.2023.05.013. Epub 2023 May 15.
- Rosas M Jr, Liu C, Hong MY. Effects of Mixed Nut Consumption on Blood Glucose, Insulin, Satiety, and the Microbiome in a Healthy Population: A Pilot Study. J Med Food. 2023 May;26(5):342-351. doi: 10.1089/jmf.2022.0121. Epub 2023 Apr 20.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 2515098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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