Nutrition, HealthyHULANCT05782218
Healthy Unique Lipids From Almonds
A study testing Almonds and Coconut in people with Nutrition, Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
This project will address the notion that "healthy" lipids such as monounsaturated fatty acids in almonds can be used by the bacteria living in our gut to generate "new" molecules with potentially interesting health properties. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Almonds and Coconut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 22 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women
- 18 to 50 years of age
- Body mass index (BMI) categorized "normal" through "overweight" (18.5 - 29.9 kg/m2)
- Able to provide informed consent in English
Who cannot join
- pregnancy or lactation
- allergy or aversion to any of the foods that will be studied and/or provided
- history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease
- history of metabolic diseases (type 2 diabetes, hyperlipidemia)
- previous gastrointestinal resection or bariatric surgery
- bleeding disorders that preclude blood draws
Show all 19Show fewer
- recent hospital admissions (past 6 months) for heart disease (MI/CVA or CHF) or other CVD/CAD conditions under physician guided therapy that is not medically stable
- cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment
- regular alcohol intake of > 2 drinks/day (equivalent to 720 mL of beer, 240 mL of wine, or 90 mL of spirits) and unwilling to abstain during the run-in week and test day
- use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vapes, etc.) and not willing to abstain during the run-in week and test day
- use of illicit drugs and not willing to abstain during the run-in week and test day
- BMI ≥30 kg/m2
- regular (daily to weekly) use of over the counter (OTC) weight-loss aids, anti-acids or anti-inflammatories, and unwilling or unable to stop taking during the run-in week and test day
- regular OTC dietary supplements that interfere with the test foods being studied including pills, chewables, liquids or powders for the following: fiber, fish oil (including cod liver oil), probiotics, and unwilling or unable to stop taking during the run-in week and test day
- oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics)
- seated blood pressure >140/90 mmHg
- fasting clinical lab tests outside acceptable values as ascertained at the screening blood draw (Glucose (fasting), Urea, Creatinine, eGFR, Sodium, ALT/GPT, AST/GOT, Alk Phos, Total Bilirubin, Total protein, Albumin, Complete blood count, hematocrit, Total Cholesterol, HDL/LDL cholesterol, Triglycerides, Insulin Free, Total Insulin, Hemoglobin A1C)
- current use of specific prescription medication(s): Coumadin, Opiates within 1 month of study, Chlorthalidone, Canagliflozin, Tetracycline, Heparin, Anti-psychotics, Chlorothiazide, Dapagliflozin, Cephalosporin, Eliquis, Lithium, Hydrochlorothiazide, Empagliflozin, Penicillin, Indapamide, Insulin, Quinolone, Metolazone, Acarbose, Lincomycin, Oral Steroids within 1 month of study, Cholestyramine, Amiloride hydrochloride, Miglitol, Macrolide, RA / psoriasis medications, Colesevelam, Spironolactone, Liraglutide, Sulfonamide, Medications for rheumatologic / hematologic active disease, Colestipol, Triamterene, Metformin, Glycopeptide Abs, Ezetimibe, Furosemide, Aminoglycosides, Fenofibrate, Bumetanide, HIV/HAART therapy, Statins, Proton-pump inhibitors
- inability to freely give informed consent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: HULA Study - Healthy Unique Lipids From Almonds
This project will address the notion that "healthy" lipids such as monounsaturated fatty acids in almonds can be used by the bacteria living in our gut to generate "new" molecules with potentially interesting health properties. This metabolite pattern is anticipated to differ significantly when compared to non-almond foods rich in saturated fats.
- Conditions
- Nutrition, Healthy
- Being tested
- Almonds, Coconut
- Keywords
- microbiome, cyclopropane, nutrition, unsaturated, fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsDietary supplement
Participants will receive 2.2 oz (62 g) of almonds to ingest within 15 minutes.
CoconutDietary supplement
Participants will receive 1 oz (30 g) of a coconut-chocolate bar and 1.4 oz (40 g) of 100% dried coconut chips to ingest within 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Almond arm | Experimental | Almonds will be provided to increase the gut content in mono and poly-unsaturated fatty acids. Receives: Dietary Supplement: Almonds |
| Coconut arm | Experimental | 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. Receives: Dietary Supplement: Coconut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of microbe-derived metabolites
Changes in the concentrations of microbe-derived metabolites in the blood and/or urine and/or stool of participants in the almond arm, versus a significantly different profile in participants in the coconut arm.
Measured: One day (during the feeding day)
Secondary outcomes (1)
Microbiome features associated with post-meal metabolite patterns
Positive or negative statistical associations between features in participants' gut microbiome and their post-meal changes in blood and/or urine and/or stool metabolites.
Measured: One day (during the feeding day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start31 Mar 2023
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Jean Debedat, PharmD/PhD, Principal investigator, University of California, DavisSean H Adams, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782218
- Sponsor's protocol ID
- 1950391
- Other IDs
- GH-22-DebedatJ-NR-01
- Acronym
- HULA
- Status last verified
- Aug 2023
- First submitted
- 17 Feb 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HULA Study - Healthy Unique Lipids From Almonds
- ClinicalTrials.gov ID
- NCT05782218
- Acronym / sponsor ID
- HULA / 1950391
- Conditions
- Nutrition, Healthy
- Keywords
- microbiome, cyclopropane, nutrition, unsaturated, fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will address the notion that "healthy" lipids such as monounsaturated fatty acids in almonds can be used by the bacteria living in our gut to generate "new" molecules with potentially interesting health properties. This metabolite pattern is anticipated to differ significantly when compared to non-almond foods rich in saturated fats.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond arm | Experimental | Dietary Supplement: AlmondsAlmonds will be provided to increase the gut content in mono and poly-unsaturated fatty acids. |
| Coconut arm | Experimental | Dietary Supplement: CoconutThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women
- 18 to 50 years of age
- Body mass index (BMI) categorized "normal" through "overweight" (18.5 - 29.9 kg/m2)
- Able to provide informed consent in English
Key exclusion criteria (19 listed)
- pregnancy or lactation
- allergy or aversion to any of the foods that will be studied and/or provided
- history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease
- history of metabolic diseases (type 2 diabetes, hyperlipidemia)
- previous gastrointestinal resection or bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlmondsParticipants will receive 2.2 oz (62 g) of almonds to ingest within 15 minutes. | Dietary supplement | Almond arm |
| CoconutParticipants will receive 1 oz (30 g) of a coconut-chocolate bar and 1.4 oz (40 g) of 100% dried coconut chips to ingest within 15 minutes. | Dietary supplement | Coconut arm |
Primary outcome
Change in the level of microbe-derived metabolites
Time frame: One day (during the feeding day)
Changes in the concentrations of microbe-derived metabolites in the blood and/or urine and/or stool of participants in the almond arm, versus a significantly different profile in participants in the coconut arm.
1 secondary outcome
Microbiome features associated with post-meal metabolite patterns
Time frame: One day (during the feeding day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Debedat, PharmD/PhD principal investigator
University of California, Davis
Sean H Adams, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almonds and Coconut in people with Nutrition, Healthy, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of microbe-derived metabolites (time frame: One day (during the feeding day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.