Trial Outcomes & Findings for Almonds: Digestive Health and Immune Function of Adults and Children (NCT NCT01973595)
NCT ID: NCT01973595
Last Updated: 2016-05-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention
Results posted on
2016-05-26
Participant Flow
Participant milestones
| Measure |
Almonds, Then no Almonds (Parents)
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.
|
No Almonds, Then Almonds (Parents)
Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
|
Almonds, Then no Almonds (Children)
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.
|
No Almonds Then Almonds (Children)
Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
|
|---|---|---|---|---|
|
Intervention Phase 1
STARTED
|
15
|
14
|
15
|
14
|
|
Intervention Phase 1
COMPLETED
|
15
|
14
|
15
|
14
|
|
Intervention Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout
STARTED
|
15
|
14
|
15
|
14
|
|
Washout
COMPLETED
|
14
|
14
|
14
|
14
|
|
Washout
NOT COMPLETED
|
1
|
0
|
1
|
0
|
|
Intervention Phase 2
STARTED
|
14
|
14
|
14
|
14
|
|
Intervention Phase 2
COMPLETED
|
14
|
14
|
14
|
14
|
|
Intervention Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Almonds, Then no Almonds (Parents)
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.
|
No Almonds, Then Almonds (Parents)
Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
|
Almonds, Then no Almonds (Children)
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.
|
No Almonds Then Almonds (Children)
Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
|
|---|---|---|---|---|
|
Washout
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Almonds: Digestive Health and Immune Function of Adults and Children
Baseline characteristics by cohort
| Measure |
Almonds, Then no Almonds (Parents)
n=15 Participants
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.
|
No Almonds, Then Almonds (Parents)
n=14 Participants
Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
|
Almonds, Then no Almonds (Children)
n=15 Participants
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
|
No Almonds, Then Almonds (Children)
n=14 Participants
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
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
14 participants
n=4 Participants
|
58 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline #1 (Week 1) to Final #1 (Week 4) of each interventionPopulation: Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed.
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.
Outcome measures
| Measure |
Almonds Consumption
n=41 Participants
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.
|
No Almonds Consumption Control
n=41 Participants
Participants were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
Almonds Consumption (Children)
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.
|
No Almonds Consumption Control (Children)
Children were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
|---|---|---|---|---|
|
Gut Microbiota Community Composition
Children
|
-0.161 log (CFU)
Standard Error 0.292
|
-.0498 log (CFU)
Standard Error 0.231
|
—
|
—
|
|
Gut Microbiota Community Composition
Parents
|
-.0116 log (CFU)
Standard Error 0.162
|
-0.407 log (CFU)
Standard Error 0.137
|
—
|
—
|
SECONDARY outcome
Timeframe: Change between Baseline to Week 4Population: 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.
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.
Outcome measures
| Measure |
Almonds Consumption
n=29 Participants
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.
|
No Almonds Consumption Control
n=28 Participants
Participants were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
Almonds Consumption (Children)
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.
|
No Almonds Consumption Control (Children)
Children were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
|---|---|---|---|---|
|
Inflammatory Status
Baseline
|
13 ng/ml
Standard Error 0.9
|
14 ng/ml
Standard Error 0.9
|
—
|
—
|
|
Inflammatory Status
Final
|
14 ng/ml
Standard Error 0.9
|
14 ng/ml
Standard Error 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-baseline (Week 0) and Week 3 of each interventionPopulation: 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.
Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.
Outcome measures
| Measure |
Almonds Consumption
n=58 Participants
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.
|
No Almonds Consumption Control
n=56 Participants
Participants were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
Almonds Consumption (Children)
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.
|
No Almonds Consumption Control (Children)
Children were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
|---|---|---|---|---|
|
Gastrointestinal Function
Parents Week 3
|
9.6 average stools per week
Standard Error 0.8
|
10.3 average stools per week
Standard Error 0.8
|
—
|
—
|
|
Gastrointestinal Function
Parents Pre-baseline
|
9.4 average stools per week
Standard Error 0.8
|
8.6 average stools per week
Standard Error 0.8
|
—
|
—
|
|
Gastrointestinal Function
Children Pre-baseline
|
6.7 average stools per week
Standard Error 6.7
|
6.1 average stools per week
Standard Error 0.5
|
—
|
—
|
|
Gastrointestinal Function
Children Week 3
|
7.4 average stools per week
Standard Error 0.5
|
6.9 average stools per week
Standard Error 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Three week almond intervention vs. three week no almond interventionPopulation: 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.
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 \[31-50 years\])
Outcome measures
| Measure |
Almonds Consumption
n=29 Participants
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.
|
No Almonds Consumption Control
n=28 Participants
Participants were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
Almonds Consumption (Children)
n=29 Participants
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.
|
No Almonds Consumption Control (Children)
n=28 Participants
Children were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
|
|---|---|---|---|---|
|
Diet Quality
|
61.4 units on a scale
Standard Error 1.4
|
53.7 units on a scale
Standard Error 1.8
|
61.4 units on a scale
Standard Error 2.2
|
53.7 units on a scale
Standard Error 2.6
|
Adverse Events
Almonds Consumption
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Almonds Consumption Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place