Walnuts to Achieve Lasting NUTrition to Prevent Diabetes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/21/2019 |
| Start Date: | May 21, 2018 |
| End Date: | July 2019 |
Walnuts to Achieve Lasting NUTrition to Prevent Diabetes (WALNUT-Diabetes)
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.
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.
Inclusion Criteria:
1. Male or female between 18-65 years of age at baseline living in the San Francisco Bay
area.
2. BMI>25 m/kg2 (or >23 m/kg2 for individuals of Asian or South Asian ethnicity)
3. Documentation of prediabetes diagnosis as evidenced by the following criteria:
1. A fasting glucose 100-125 mg/dL, or a HbA1c measurement of 5.7-6.4%, OR a
diagnosis of "prediabetes" or "impaired fasting glucose" in the past 6 months,
identified through an electronic medical record query from patients at UCSF and
through outside recruitment in the surrounding community
2. We will confirm eligibility of potential participants by repeating fasting
capillary blood glucose measurements at the baseline visit to ensure that they
have prediabetes
4. Written informed consent and ability for subject to comply with the requirements of
the study.
Exclusion Criteria:
1. Pregnant or breastfeeding women at enrollment.
2. Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the patient or the quality of the data, such as
diverticulosis or diverticulitis.
3. Tree or peanut allergies
4. Unwilling to consume a daily walnut supplement.
5. Diagnosis of diabetes
6. On glucose lowering medications
7. Dietician-managed dietary intake, or personal or medical dietary restrictions that do
not allow consumption of walnuts
8. Malabsorptive conditions including intestinal bypass surgery, pancreatitis,
inflammatory bowel disease
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