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Almonds: Digestive Health and Immune Function of Adults and Children

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ClinicalTrials.gov Identifier: NCT01973595
Recruitment Status : Completed
First Posted : October 31, 2013
Results First Posted : April 25, 2016
Last Update Posted : May 26, 2016
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Healthy
Interventions Dietary Supplement: Almonds, Then no almonds
Other: No Almonds, Then almonds
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Almonds, Then no Almonds (Parents) No Almonds, Then Almonds (Parents) Almonds, Then no Almonds (Children) No Almonds Then Almonds (Children)
Hide Arm/Group Description

Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.

Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
Period Title: Intervention Phase 1
Started 15 14 15 14
Completed 15 14 15 14
Not Completed 0 0 0 0
Period Title: Washout
Started 15 14 15 14
Completed 14 14 14 14
Not Completed 1 0 1 0
Reason Not Completed
Withdrawal by Subject             1             0             1             0
Period Title: Intervention Phase 2
Started 14 14 14 14
Completed 14 14 14 14
Not Completed 0 0 0 0
Arm/Group Title Almonds, Then no Almonds (Parents) No Almonds, Then Almonds (Parents) Almonds, Then no Almonds (Children) No Almonds, Then Almonds (Children) Total
Hide Arm/Group Description

Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.

Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste

Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet. Total of all reporting groups
Overall Number of Baseline Participants 15 14 15 14 58
Hide Baseline Analysis Population Description
Data from parents and children were analyzed separately. All parents and children received both treatments arms.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 15 participants 14 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
15
 100.0%
14
 100.0%
29
  50.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
0
   0.0%
0
   0.0%
29
  50.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 15 participants 14 participants 58 participants
Female
13
  86.7%
11
  78.6%
9
  60.0%
5
  35.7%
38
  65.5%
Male
2
  13.3%
3
  21.4%
6
  40.0%
9
  64.3%
20
  34.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 15 participants 14 participants 58 participants
15 14 15 14 58
1.Primary Outcome
Title Gut Microbiota Community Composition
Hide Description 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.
Time Frame Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed.
Arm/Group Title Almonds Consumption No Almonds Consumption Control
Hide Arm/Group Description:

Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Participants were asked not to consume almonds for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Overall Number of Participants Analyzed 41 41
Mean (Standard Error)
Unit of Measure: log (CFU)
Parents -.0116  (0.162) -0.407  (0.137)
Children -0.161  (0.292) -.0498  (0.231)
2.Secondary Outcome
Title Inflammatory Status
Hide Description 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.
Time Frame Change between Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Parents (Almonds baseline, n=29, final n=29, No almonds baseline n=28, final n= 28; one parent withdrew prior to no almond consumption control intervention) were analyzed for almonds and no almond consumption, no children were included in this analysis.
Arm/Group Title Almonds Consumption (Parents) No Almonds Consumption Control (Parents)
Hide Arm/Group Description:

Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Parents were asked not to consume almonds for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Overall Number of Participants Analyzed 29 28
Mean (Standard Error)
Unit of Measure: ng/ml
Baseline 13  (0.9) 14  (0.9)
Final 14  (0.9) 14  (0.9)
3.Secondary Outcome
Title Gastrointestinal Function
Hide Description Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.
Time Frame Pre-baseline (Week 0) and Week 3 of each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
29 parents and 29 children consumed almonds n=58; one parent-child pair withdrew prior to no almond consumption control intervention n=56; parents and children were analyzed for almonds and no almond consumption.
Arm/Group Title Almonds Consumption No Almond Consumption Control
Hide Arm/Group Description:

Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Participants were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.

Each group received the almond intervention and the no almond consumption control.

Overall Number of Participants Analyzed 58 56
Mean (Standard Error)
Unit of Measure: average stools per week
Parents Pre-baseline 9.4  (0.8) 8.6  (0.8)
Parents Week 3 9.6  (0.8) 10.3  (0.8)
Children Pre-baseline 6.7  (6.7) 6.1  (0.5)
Children Week 3 7.4  (0.5) 6.9  (0.5)
4.Secondary Outcome
Title Diet Quality
Hide Description

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])

Time Frame Three week almond intervention vs. three week no almond intervention
Hide Outcome Measure Data
Hide Analysis Population Description
29 Parents and 29 children were analyzed separately for almonds and no almond consumption; one parent-child pair withdrew prior to no almond consumption control.
Arm/Group Title Almonds Consumption (Parents) No Almonds Consumption Control (Parents) Almonds Consumption (Children) No Almonds Consumption Control (Children)
Hide Arm/Group Description:

Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Parents were asked not to consume almonds for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Children were asked not to consume almonds for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Overall Number of Participants Analyzed 29 28 29 28
Mean (Standard Error)
Unit of Measure: units on a scale
61.4  (1.4) 53.7  (1.8) 61.4  (2.2) 53.7  (2.6)
Time Frame 14 weeks; pre-baseline (week 0) to final follow up week (week 14)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Almonds Consumption No Almonds Consumption Control
Hide Arm/Group Description

Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Participants were asked not to consume almonds for 3 weeks.

Each group received the almond intervention and the no almond consumption control.

All-Cause Mortality
Almonds Consumption No Almonds Consumption Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Almonds Consumption No Almonds Consumption Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Almonds Consumption No Almonds Consumption Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/58 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bobbi Langkamp- Henken
Organization: University of Florida
Phone: 352-392-1991 ext 205
EMail: henken@ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01973595     History of Changes
Other Study ID Numbers: 201300475
First Submitted: October 15, 2013
First Posted: October 31, 2013
Results First Submitted: November 12, 2015
Results First Posted: April 25, 2016
Last Update Posted: May 26, 2016