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Healthy Lipids
Almonds + Coconut for Healthy Nutrition (HULA Trial)
N/A
Waitlist Available
Led By Sean H Adams, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day (inclusion visit)
Awards & highlights
Summary
This trial will explore how eating almonds can alter gut bacteria to create molecules that can improve health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one day (during the feeding day)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day (during the feeding day)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the level of microbe-derived metabolites
Secondary outcome measures
Microbiome features associated with post-meal metabolite patterns
Other outcome measures
Relationship between dietary habits and baseline (pre-meal) microbiota-derived blood metabolite levels in the baseline blood.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Coconut armExperimental Treatment1 Intervention
This snack is isocaloric and almost perfectly matches the macronutrient profile of the almonds. However, despite being in the same quantity, almost all provided fatty acids will be saturated fatty acids.
Group II: Almond armExperimental Treatment1 Intervention
Almonds will be provided to increase the gut content in mono and poly-unsaturated fatty acids.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coconut
2016
N/A
~140
Almonds
2008
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
Almond Board of CaliforniaOTHER
34 Previous Clinical Trials
2,201 Total Patients Enrolled
University of California, DavisLead Sponsor
919 Previous Clinical Trials
4,720,872 Total Patients Enrolled
1 Trials studying Healthy Nutrition
17 Patients Enrolled for Healthy Nutrition
Sean H Adams, PhDPrincipal InvestigatorUniversity of California, Davis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 18 and 50 years of age.You are able to provide consent in English.Your BMI falls between 18.5 and 29.9 kg/m2, indicating that you are of normal or overweight weight range.You smoke tobacco or marijuana, use e-cigarettes or hookahs, and are not willing to stop during the week before and on the day of the test.You frequently use over-the-counter weight loss supplements, antacids, or anti-inflammatory medications and cannot stop taking them during the testing period.You are pregnant or breastfeeding.Both men and women.You have had problems with your digestive system such as ulcerative colitis, Crohn's disease, celiac sprue, or liver disease.You have a food allergy or dislike to any of the foods being studied or offered.You drink more than two drinks per day (such as two beers or two glasses of wine) and are not willing to stop drinking during the week before the test.You must not use illegal drugs during the week before and on the day of the test, and you must agree to this condition.You regularly take certain supplements like fiber, fish oil, or probiotics that may affect the results of the study. You cannot stop taking them during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Coconut arm
- Group 2: Almond arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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