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| Name | Class |
|---|---|
| Almond Board of California | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| No almonds then almonds | Other | No almonds will be consumed by participants for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonds, Then no almonds | Dietary Supplement | Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change between Baseline to Week 4 |
| Gastrointestinal Function |
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Inclusion Criteria:
To participate in the study, adult participants must:
Exclusion Criteria:
To participate in the study, adult and child participants:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26773784 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Phase 1 |
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| Washout |
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| Intervention Phase 2 |
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Data from parents and children were analyzed separately. All parents and children received both treatments arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed. | Posted | Mean | Standard Error | log (CFU) | Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention |
|
14 weeks; pre-baseline (week 0) to final follow up week (week 14)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Almonds Consumption | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bobbi Langkamp- Henken | University of Florida | 352-392-1991 | 205 | henken@ufl.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| No Almonds, Then almonds | Other | No almonds will be consumed by participants for 3 weeks. |
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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 | 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 |
| COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| 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. |
| BG002 | 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 |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| No Almonds Consumption Control |
Participants were asked not to consume almonds for 3 weeks. Each group received the almond intervention and the no almond consumption control. |
|
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| Secondary | 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. | 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. | Posted | Mean | Standard Error | ng/ml | Change between Baseline to Week 4 |
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| Secondary | 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. | 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. | Posted | Mean | Standard Error | average stools per week | Pre-baseline (Week 0) and Week 3 of each intervention |
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| Secondary | 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]) | 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. | Posted | Mean | Standard Error | units on a scale | Three week almond intervention vs. three week no almond intervention |
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| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | No Almonds Consumption Control | Participants were asked not to consume almonds for 3 weeks. Each group received the almond intervention and the no almond consumption control. | 0 | 58 | 0 | 58 |
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| Children Pre-baseline |
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| Children Week 3 |
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