Almonds: Digestive Health and Immune Function of Adults and Children

April 26, 2016 updated by: University of Florida

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Almonds then no almonds
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.
Dietary supplement: Almonds, Then no almonds
Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.
Other: No almonds then almonds
No almonds will be consumed by participants for 3 weeks.
Other: No Almonds, Then almonds
No almonds will be consumed by participants for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammatory Status
Time Frame: Change between Baseline to Week 4
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.
Change between Baseline to Week 4
Gastrointestinal Function
Time Frame: Pre-baseline (Week 0) and Week 3 of each intervention
Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.
Pre-baseline (Week 0) and Week 3 of each intervention
Diet Quality
Time Frame: Three week almond intervention vs. three week no almond intervention

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])
Three week almond intervention vs. three week no almond intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Almond Board of California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201300475

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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