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Prediabetes is a precursor of type 2 diabetes and an independent risk factor for cardiovascular disease, and currently affects one-quarter of the population of the United States. Individuals of overweight or obese BMI are at particular high risk for incident diabetes. A major modifiable risk factor for type 2 diabetes is poor dietary quality, and improvement of dietary quality can effectively delay and even prevent type 2 diabetes. Interventions to improve dietary quality thus far, however, rely on short-term intensive clinically designed meals replacing the entire diet which have poor sustainability. Persistent improvements to daily dietary patterns are often difficult without directed guidance, and overall dietary quality in the United States remains poor. The identification of a practical, daily dietary intervention to improve dietary quality and prevent diabetes in those at high risk remains unknown. The investigators propose to enroll 40 individuals with diagnosed prediabetes into a randomized controlled pilot study and provide a daily walnut supplementation intervention to determine feasibility and acceptability of the supplement. The investigators will then determine preliminary efficacy on metabolic markers and will investigate associations between dietary quality and circulating levels of branched-chain amino acids. The goal is to implement a whole-food supplement to improve dietary quality in patients with prediabetes as a tool for future type 2 diabetes prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walnuts Now | Experimental | Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention. |
|
| Walnuts Later | No Intervention | Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walnuts | Drug | 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Recruited and Retained | Number of participants recruited and retained | 12 weeks |
| Adherence to the Intervention | Adherence to the intervention was determined through daily food diaries. Participants detailed daily consumption of the walnut supplement on a calendar provided at the outset of the study. Percentage was determined as number of days consuming supplement over 84 days total. | 12 weeks |
| Palatability of Supplement | Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant." | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diet Quality | Change in diet quality measured by Healthy Eating Index-2010 Score (0 - 100). Higher scores indicate better diet quality. | 0 weeks and 12 weeks |
| Fasting Glucose | Change in fasting glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Plasma Metabolomics Performed | Plasma metabolomics performed as an exploratory outcome for all participants. This outcome represents number of participants who had a successful blood draw at both baseline and 12 weeks sent to the laboratory with usable data recovered. | 0 weeks and 12 weeks |
Inclusion Criteria:
Male or female between 18-65 years of age at baseline living in the San Francisco Bay area.
BMI>25 m/kg2 (or >23 m/kg2 for individuals of Asian or South Asian ethnicity)
Documentation of prediabetes diagnosis as evidenced by the following criteria:
Written informed consent and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghana Gadgil, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Walnuts Now | Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention. Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food. |
| FG001 | Walnuts Later | Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Walnuts Now | Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention. Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food. |
| BG001 | Walnuts Later |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Recruited and Retained | Number of participants recruited and retained | Posted | Count of Participants | Participants | 12 weeks |
|
12 weeks
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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 | Walnuts Now | Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention. Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghana Gadgil | UCSF | 4153537922 | meghana.gadgil@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2018 | Jul 21, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 0 weeks and 12 weeks |
| Change in Hemoglobin A1c | Change in percentage of Hemoglobin A1c | 0 weeks and 12 weeks |
| Change in Low Density Lipoprotein Levels | Change in low density lipoprotein levels from baseline to 12 weeks | 0 weeks and 12 weeks |
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fasting glucose | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1c | Mean | Standard Deviation | percentage of Hemoglobin A1c |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | Adherence to the Intervention | Adherence to the intervention was determined through daily food diaries. Participants detailed daily consumption of the walnut supplement on a calendar provided at the outset of the study. Percentage was determined as number of days consuming supplement over 84 days total. | Adherence was not measured in the control group who did not receive the walnut supplement. | Posted | Mean | Full Range | percentage of days | 12 weeks |
|
|
|
| Primary | Palatability of Supplement | Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant." | Palatability was not measured in the control group who did not receive the walnut supplement intervention. | Posted | Mean | Full Range | score on a scale | 12 weeks |
|
|
|
| Secondary | Change in Diet Quality | Change in diet quality measured by Healthy Eating Index-2010 Score (0 - 100). Higher scores indicate better diet quality. | The "Walnuts Later" group did not complete the food frequency questionnaire required to assess change in diet quality. As the primary outcome was feasibility of recruitment and retention, we chose to analyze diet quality data only in those participants who provided these data. | Posted | Mean | Standard Deviation | score on a scale | 0 weeks and 12 weeks |
|
|
|
| Secondary | Fasting Glucose | Change in fasting glucose | Posted | Mean | Standard Deviation | mg/dL | 0 weeks and 12 weeks |
|
|
|
| Secondary | Change in Hemoglobin A1c | Change in percentage of Hemoglobin A1c | Posted | Mean | Standard Deviation | percentage of A1c | 0 weeks and 12 weeks |
|
|
|
| Secondary | Change in Low Density Lipoprotein Levels | Change in low density lipoprotein levels from baseline to 12 weeks | Posted | Mean | Standard Deviation | mg/dL | 0 weeks and 12 weeks |
|
|
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| Other Pre-specified | Number of Participants Who Had Plasma Metabolomics Performed | Plasma metabolomics performed as an exploratory outcome for all participants. This outcome represents number of participants who had a successful blood draw at both baseline and 12 weeks sent to the laboratory with usable data recovered. | Posted | Count of Participants | Participants | 0 weeks and 12 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Walnuts Later | Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |