HealthyNCT01973595
Almonds: Digestive Health and Immune Function of Adults and Children
A study testing Almonds, Then no almonds and No Almonds, Then almonds in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine whether incorporating almonds into the diets of families with young children will induce beneficial changes in gastrointestinal function, the fecal microbiota profile, and immune and inflammatory processes of the adults and children resulting in improved quality of life. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Almonds, Then no almonds and No Almonds, Then almonds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To participate in the study, adult participants must:
- Be 18 to 40 years old.
- Have a 3 to 6 year old child that you are willing to enroll in the study.
- Live with your child for on average at least 6 days of the week.
- Be willing and able to complete the Informed Consent Form in English.
- Not be currently pregnant or planning to become pregnant in the next 5 months.
Show all 13Show fewer
- Be willing to consume 1.5 ounces of almonds (~43 nuts) each day for three weeks.
- Be willing to feed your child 0.5 ounces of almond paste (~2 tablespoons) per day for three weeks.
- Be willing monitor your child's daily intake over the course of the study.
- Be willing to provide 4 blood samples, 4 stool samples, and 4 saliva samples over the course of the study.
- Be willing to assist your child in providing 4 stool samples and 4 saliva samples over the course of the study.
- Be willing and able to complete daily and weekly questionnaires for you and your child regarding general wellness, bowel function, gastrointestinal symptoms, stress and anxiety, and dietary intake.
- Must be available for 14 consecutive weeks to participate in the study.
Who cannot join
- To participate in the study, adult and child participants:
- Must not have any known nut or tree nut allergies.
- Must discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, fish oil, vitamin E >400% of the Recommended Dietary Allowance (RDA) or >60 mg/day, and yogurts with live, active cultures).
- Must not be currently taking any medications for constipation or diarrhea on a regular basis.
- Must not be currently taking any large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
- Must not have received antibiotic therapy or a colonoscopy in the past two months.
- Must not be currently being treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including gastroesophageal reflux disease; or have a central venous catheter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Almonds: Digestive Health and Immune Function of Adults and Children: a Randomized Crossover Study
The purpose of this study is to determine whether incorporating almonds into the diets of families with young children will induce beneficial changes in gastrointestinal function, the fecal microbiota profile, and immune and inflammatory processes of the adults and children resulting in improved quality of life. The investigators anticipate finding an increase in beneficial bacteria, improved intestinal function, and decreased inflammation during the almond intervention.
Read the detailed description
This is a randomized, crossover study. After obtaining informed consent, healthy adults aged 18-40 years with children aged 3-6 years will be randomized to either consume almonds and almond paste during the first arm of the study or during the second arm of the study. During the intervention period, adult participants will consume 1.5 ounces of almonds per day, and children will consume 0.5 ounces of almonds per day for 3 weeks. After a 4-week washout period, participants will be crossed to the other treatment (no almond consumption or almond consumption).
Participants will complete daily questionnaires throughout the intervention period, and one week before and after each intervention period. Blood samples will be collected from adults at the baseline and final time points of each intervention. Stool samples will be collected during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed weekly during each intervention period. Gastrointestinal symptoms questionnaires will be completed weekly during each intervention.
- Conditions
- Healthy
- Being tested
- Almonds, Then no almonds, No Almonds, Then almonds
- Keywords
- almonds, inflammation, immunity, gut microbiota, stress, diet quality
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almonds, Then no almondsDietary supplement
Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.
No Almonds, Then almondsOther
No almonds will be consumed by participants for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Almonds then no almonds | Experimental | Adults will consume 1.5 ounces of almonds or almond paste per day and children will consume 0.5 ounces of almonds or almond paste per day for 3 weeks. Receives: Dietary Supplement: Almonds, Then no almonds |
| No almonds then almonds | Other | No almonds will be consumed by participants for 3 weeks. Receives: Other: No Almonds, Then almonds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota Community Composition
The mean of the change between baseline and final time points in stool lactic acid bacteria counts [log(CFU)] was compared for each study arm.
Measured: Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention
Secondary outcomes (3)
Inflammatory Status
Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four.
Measured: Change between Baseline to Week 4
Gastrointestinal Function
Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.
Measured: Pre-baseline (Week 0) and Week 3 of each intervention
Diet Quality
Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).
High component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.
National averages total score: children: 54.9 [4-8 years] and adults: 57.4 [31-50 years])
Measured: Three week almond intervention vs. three week no almond intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973595
- Sponsor's protocol ID
- 201300475
- Status last verified
- Apr 2016
- First submitted
- 15 Oct 2013
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Burns AM, Zitt MA, Rowe CC, Langkamp-Henken B, Mai V, Nieves C Jr, Ukhanova M, Christman MC, Dahl WJ. Diet quality improves for parents and children when almonds are incorporated into their daily diet: a randomized, crossover study. Nutr Res. 2016 Jan;36(1):80-9. doi: 10.1016/j.nutres.2015.11.004. Epub 2015 Nov 10.
PubMed 26773784
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almonds: Digestive Health and Immune Function of Adults and Children: a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT01973595
- Acronym / sponsor ID
- 201300475
- Conditions
- Healthy
- Keywords
- almonds, inflammation, immunity, gut microbiota, stress, diet quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 25 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether incorporating almonds into the diets of families with young children will induce beneficial changes in gastrointestinal function, the fecal microbiota profile, and immune and inflammatory processes of the adults and children resulting in improved quality of life. The investigators anticipate finding an increase in beneficial bacteria, improved intestinal function, and decreased inflammation during the almond intervention.
Detailed description
This is a randomized, crossover study. After obtaining informed consent, healthy adults aged 18-40 years with children aged 3-6 years will be randomized to either consume almonds and almond paste during the first arm of the study or during the second arm of the study. During the intervention period, adult participants will consume 1.5 ounces of almonds per day, and children will consume 0.5 ounces of almonds per day for 3 weeks. After a 4-week washout period, participants will be crossed to the other treatment (no almond consumption or almond consumption).
Participants will complete daily questionnaires throughout the intervention period, and one week before and after each intervention period. Blood samples will be collected from adults at the baseline and final time points of each intervention. Stool samples will be collected during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed weekly during each intervention period. Gastrointestinal symptoms questionnaires will be completed weekly during each intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almonds then no almonds | Experimental | Dietary Supplement: Almonds, Then no almondsAdults will consume 1.5 ounces of almonds or almond paste per day and children will consume 0.5 ounces of almonds or almond paste per day for 3 weeks. |
| No almonds then almonds | Other | Other: No Almonds, Then almondsNo almonds will be consumed by participants for 3 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Be 18 to 40 years old.
- Have a 3 to 6 year old child that you are willing to enroll in the study.
- Live with your child for on average at least 6 days of the week.
- Be willing and able to complete the Informed Consent Form in English.
- Not be currently pregnant or planning to become pregnant in the next 5 months.
Key exclusion criteria (7 listed)
- Must not have any known nut or tree nut allergies.
- Must discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, fish oil, vitamin E >400% of the Recommended Dietary Allowance (RDA) or >60 mg/day, and yogurts with live, active cultures).
- Must not be currently taking any medications for constipation or diarrhea on a regular basis.
- Must not be currently taking any large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
- Must not have received antibiotic therapy or a colonoscopy in the past two months.
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 |
|---|---|---|
| Almonds, Then no almondsWhole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste. | Dietary supplement | Almonds then no almonds |
| No Almonds, Then almondsNo almonds will be consumed by participants for 3 weeks. | Other | No almonds then almonds |
Primary outcome
Gut Microbiota Community Composition
Time frame: Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention
The mean of the change between baseline and final time points in stool lactic acid bacteria counts [log(CFU)] was compared for each study arm.
3 secondary outcomes
Inflammatory Status
Time frame: Change between Baseline to Week 4
Gastrointestinal Function
Time frame: Pre-baseline (Week 0) and Week 3 of each intervention
Diet Quality
Time frame: Three week almond intervention vs. three week no almond intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26773784Burns AM, Zitt MA, Rowe CC, Langkamp-Henken B, Mai V, Nieves C Jr, Ukhanova M, Christman MC, Dahl WJ. Diet quality improves for parents and children when almonds are incorporated into their daily diet: a randomized, crossover study. Nutr Res. 2016 Jan;36(1):80-9. doi: 10.1016/j.nutres.2015.11.004. Epub 2015 Nov 10.
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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.
Bobbi Langkamp-Henken, PhD, RD principal investigator
University of Florida
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, Then no almonds and No Almonds, Then almonds in people with Healthy, run by University of Florida 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 13 inclusion and 7 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 26 May 2016. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gut Microbiota Community Composition (time frame: Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973595, which also lists 1 linked publication.
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 26 May 2016.