Clinical trial NCT03334175: Walnuts to Achieve Lasting NUTrition to Prevent Diabetes
Official title: Walnuts to Achieve Lasting NUTrition to Prevent Diabetes (WALNUT-Diabetes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: PreDiabetes
Overweight and Obesity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Recruited and Retained
timeFrame: 12 weeks
measure: Adherence to the Intervention
timeFrame: 12 weeks
measure: Palatability of Supplement
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Diet Quality
timeFrame: 0 weeks and 12 weeks
measure: Fasting Glucose
timeFrame: 0 weeks and 12 weeks
measure: Change in Hemoglobin A1c
timeFrame: 0 weeks and 12 weeks
measure: Change in Low Density Lipoprotein Levels
timeFrame: 0 weeks and 12 weeks
Other outcomes:
measure: Number of Participants Who Had Plasma Metabolomics Performed
timeFrame: 0 weeks and 12 weeks
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Meghana Gadgil, MD
role: PRINCIPAL_INVESTIGATOR
References: