search
Back to results

Walnuts to Achieve Lasting NUTrition to Prevent Diabetes

Primary Purpose

PreDiabetes, Overweight and Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Walnuts
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Walnuts Now

Walnuts Later

Arm Description

Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during 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.

Outcomes

Primary Outcome Measures

Number of Participants Recruited and Retained
Number of participants recruited and retained
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.
Palatability of Supplement
Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant."

Secondary Outcome Measures

Change in Diet Quality
Change in diet quality measured by Healthy Eating Index-2010 Score (0 - 100). Higher scores indicate better diet quality.
Fasting Glucose
Change in fasting glucose
Change in Hemoglobin A1c
Change in percentage of Hemoglobin A1c
Change in Low Density Lipoprotein Levels
Change in low density lipoprotein levels from baseline to 12 weeks

Full Information

First Posted
October 30, 2017
Last Updated
August 20, 2020
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT03334175
Brief Title
Walnuts to Achieve Lasting NUTrition to Prevent Diabetes
Official Title
Walnuts to Achieve Lasting NUTrition to Prevent Diabetes (WALNUT-Diabetes)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walnuts Now
Arm Type
Experimental
Arm Description
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Arm Title
Walnuts Later
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Walnuts
Intervention Description
1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
Primary Outcome Measure Information:
Title
Number of Participants Recruited and Retained
Description
Number of participants recruited and retained
Time Frame
12 weeks
Title
Adherence to the Intervention
Description
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.
Time Frame
12 weeks
Title
Palatability of Supplement
Description
Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant."
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Diet Quality
Description
Change in diet quality measured by Healthy Eating Index-2010 Score (0 - 100). Higher scores indicate better diet quality.
Time Frame
0 weeks and 12 weeks
Title
Fasting Glucose
Description
Change in fasting glucose
Time Frame
0 weeks and 12 weeks
Title
Change in Hemoglobin A1c
Description
Change in percentage of Hemoglobin A1c
Time Frame
0 weeks and 12 weeks
Title
Change in Low Density Lipoprotein Levels
Description
Change in low density lipoprotein levels from baseline to 12 weeks
Time Frame
0 weeks and 12 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants Who Had Plasma Metabolomics Performed
Description
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.
Time Frame
0 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 We will confirm eligibility of potential participants by repeating fasting capillary blood glucose measurements at the baseline visit to ensure that they have prediabetes Written informed consent and ability for subject to comply with the requirements of the study. Exclusion Criteria: Pregnant or breastfeeding women at enrollment. 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. Tree or peanut allergies Unwilling to consume a daily walnut supplement. Diagnosis of diabetes On glucose lowering medications Dietician-managed dietary intake, or personal or medical dietary restrictions that do not allow consumption of walnuts Malabsorptive conditions including intestinal bypass surgery, pancreatitis, inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghana Gadgil, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Walnuts to Achieve Lasting NUTrition to Prevent Diabetes

We'll reach out to this number within 24 hrs