Healthy
Conditions
Keywords
almonds, inflammation, immunity, gut microbiota, stress, diet quality
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTAlmonds, Then no almonds
Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.
OTHERNo Almonds, Then almonds
No almonds will be consumed by participants for 3 weeks.
Sponsors
Almond Board of California
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiota Community Composition | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Status | 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. |
| Gastrointestinal Function | 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. |
| Diet Quality | 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 \[31-50 years\]) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 14 |
| 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 | 15 |
| 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. | 14 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Washout | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Almonds, Then no Almonds (Parents) | No Almonds, Then Almonds (Parents) | Almonds, Then no Almonds (Children) | No Almonds, Then Almonds (Children) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 15 Participants | 14 Participants | 29 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 0 Participants | 0 Participants | 29 Participants |
| Region of Enrollment United States | 15 participants | 14 participants | 15 participants | 14 participants | 58 participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 9 Participants | 5 Participants | 38 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 6 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
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.
Time frame: Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Almonds Consumption | Gut Microbiota Community Composition | Parents | -.0116 log (CFU) | Standard Error 0.162 |
| Almonds Consumption | Gut Microbiota Community Composition | Children | -0.161 log (CFU) | Standard Error 0.292 |
| No Almonds Consumption Control | Gut Microbiota Community Composition | Parents | -0.407 log (CFU) | Standard Error 0.137 |
| No Almonds Consumption Control | Gut Microbiota Community Composition | Children | -.0498 log (CFU) | Standard Error 0.231 |
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 \[31-50 years\])
Time frame: Three week almond intervention vs. three week no almond intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Almonds Consumption | Diet Quality | 61.4 units on a scale | Standard Error 1.4 |
| No Almonds Consumption Control | Diet Quality | 53.7 units on a scale | Standard Error 1.8 |
| Almonds Consumption (Children) | Diet Quality | 61.4 units on a scale | Standard Error 2.2 |
| No Almonds Consumption Control (Children) | Diet Quality | 53.7 units on a scale | Standard Error 2.6 |
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.
Time frame: Pre-baseline (Week 0) and Week 3 of each intervention
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Almonds Consumption | Gastrointestinal Function | Parents Pre-baseline | 9.4 average stools per week | Standard Error 0.8 |
| Almonds Consumption | Gastrointestinal Function | Parents Week 3 | 9.6 average stools per week | Standard Error 0.8 |
| Almonds Consumption | Gastrointestinal Function | Children Pre-baseline | 6.7 average stools per week | Standard Error 6.7 |
| Almonds Consumption | Gastrointestinal Function | Children Week 3 | 7.4 average stools per week | Standard Error 0.5 |
| No Almonds Consumption Control | Gastrointestinal Function | Children Week 3 | 6.9 average stools per week | Standard Error 0.5 |
| No Almonds Consumption Control | Gastrointestinal Function | Parents Pre-baseline | 8.6 average stools per week | Standard Error 0.8 |
| No Almonds Consumption Control | Gastrointestinal Function | Children Pre-baseline | 6.1 average stools per week | Standard Error 0.5 |
| No Almonds Consumption Control | Gastrointestinal Function | Parents Week 3 | 10.3 average stools per week | Standard Error 0.8 |
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.
Time frame: Change between Baseline to Week 4
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Almonds Consumption | Inflammatory Status | Baseline | 13 ng/ml | Standard Error 0.9 |
| Almonds Consumption | Inflammatory Status | Final | 14 ng/ml | Standard Error 0.9 |
| No Almonds Consumption Control | Inflammatory Status | Baseline | 14 ng/ml | Standard Error 0.9 |
| No Almonds Consumption Control | Inflammatory Status | Final | 14 ng/ml | Standard Error 0.9 |