- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04096586
Effects of Watermelon Consumption on Satiety and Digestive Health
March 14, 2024 updated by: Mee Young Hong, San Diego State University
The objective of the proposed research is to determine the effects of watermelon (fruit and rind blenderized) on satiety, metabolic markers, bowel habits, microbiome and weight management in children and adults
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 55 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Generally healthy subjects
Exclusion Criteria:
- Smoker
- Pregnant woman
- Required dietary supplement use
- Required medication of metabolic disorders
- Allergy to watermelon
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Red juice
Subjects consume 8 fl oz of red juice daily for 8 weeks
|
To determine the effects of red juice on satiety and gut health
|
Experimental: Watermelon juice
Subjects consume 8 fl oz of watermelon juice daily for 8 weeks
|
To determine the effects of watermelon juice on satiety and gut health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of satiety
Time Frame: 0 and 20, 40, 60, 90 and 120 minutes post juice consumption
|
Change of hunger feeling (appetite) will be examined using visual analog scale (0-10), 0 least and 10 greatest
|
0 and 20, 40, 60, 90 and 120 minutes post juice consumption
|
Change of glucose level
Time Frame: 0 and 20, 40, 60, 90 and 120 minutes post juice consumption
|
Change of blood glucose level will be determined to examine effects of watermelon juice consumption vs red juice
|
0 and 20, 40, 60, 90 and 120 minutes post juice consumption
|
Change of insulin level
Time Frame: 0 and 20, 40, 60, 90 and 120 minutes post juice consumption
|
Change of blood insulin level will be determined to examine effects of watermelon juice consumption vs red juice
|
0 and 20, 40, 60, 90 and 120 minutes post juice consumption
|
Change of triglyceride level
Time Frame: Baseline and week 8
|
Change of triglyceride level with watermelon juice consumption vs red juice consumption
|
Baseline and week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of alpha diversity in microbiome
Time Frame: Baseline and week 8
|
Change of alpha diversity in micriobiome with watermelon juice consumption vs red juice consumption
|
Baseline and week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
September 18, 2019
First Posted (Actual)
September 20, 2019
Study Record Updates
Last Update Posted (Actual)
March 18, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- HS-2019-0103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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