Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Almond Board of California | OTHER |
Not provided
Not provided
Not provided
The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.
This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention arm consists of daily consumption of the investigator's intervention snack over the course of 12 weeks. |
|
| Isocaloric Control | Placebo Comparator | The control arm consists of daily consumption of an isocaloric snack over the course of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonds | Dietary Supplement | Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gastrointestinal microbiota composition | Determine the impact of daily consumption of almonds on the gastrointestinal microbiota compared to control (pretzels) by sequencing the V4 region of the 16S rRNA gene in fecal samples. | Baseline & 12-week mark |
| Changes in abundance of fecal Roseburia spp | Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR. | Baseline & 12-week mark |
| Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase | Determine the impact of daily consumption of almonds on the abundance of Butyryl CoA: Acetate CoA transferase gene compared to control (pretzels) by using quantitative real-time PCR. | Baseline & 12-week mark |
| Changes in gastrointestinal microbial-derived metabolite concentrations | Determine the impact of daily consumption of almonds on the concentration of microbial-derived metabolites compared to control (pretzels) by using gas-liquid chromatography. These metabolites include butyrate and secondary bile acids. | Baseline & 12-week mark |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in liver fat | Determine the impact of daily consumption of almonds on liver fat percentages compared to control (pretzels) by quantitative liver ultrasound. | Baseline & 12-week mark |
| Changes in glycemic control. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in markers of systemic inflammation & metabolism | Determine the impact of daily consumption of almonds on inflammation and metabolism compared to control (pretzels) by measuring biomarker concentrations with ELISA. Specifically, we will look at TNF, CRP, & LPS-BP (inflammatory) and NEFAs (metabolism). | Baseline & 12-week mark |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hannah D Holscher, PhD RD | University of Illinois at Urbana-Champaign | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana-Champaign | Urbana | Illinois | 61801 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pretzels | Dietary Supplement | Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks. |
|
Determine the impact on oral glucose tolerance within intervention (almond) and control (pretzel) groups by using a mixed meal tolerance test.
| Baseline & 12-week mark |
| Changes in secondary measures of gastrointestinal health. | Determine the impact of daily consumption of almonds on gastrointestinal health compared to control (pretzels) by measuring fecal pH; other microbial fermentation end products and microbial-derived bile acids using gas-liquid chromatography; and alpha- and beta- diversity measures of the gut microbiota community structure using 16S microbiota analyses. | Baseline & 12-week mark |
| Changes in adiposity. |
Determine the impact of daily consumption of almonds on adiposity compared to control (pretzels) using a DXA scan. |
| Baseline & 12-week mark |
| Changes in subjective measures of gastrointestinal health. | Determine the impact of daily consumption of almonds on subjective measures of gut health compared to control (pretzels) using stool records. The questionnaire addresses questions related to gastrointestinal health including bloating, flatulence, and stool consistency. | Baseline & 12-week mark |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |