PreDiabetesPhase 1/2NCT03334175
Walnuts to Achieve Lasting NUTrition to Prevent Diabetes
A Phase 1/2 study testing Walnuts in people with PreDiabetes and Overweight and Obesity, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PreDiabetes, Overweight and Obesity
- What is being tested?
- Walnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 5 Aug 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
- Conditions
- PreDiabetes, Overweight and Obesity
- Being tested
- Walnuts
- Medical subject headings
- Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalnutsDrug
1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
| Study group | Role | What they receive |
|---|---|---|
| Walnuts Now | Experimental | Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention. Receives: Drug: Walnuts |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recruited and Retained
Number of participants recruited and retained
Measured: 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.
Measured: 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."
Measured: 12 weeks
Secondary outcomes (4)
Change in Diet Quality
Change in diet quality measured by Healthy Eating Index-2010 Score (0 - 100). Higher scores indicate better diet quality.
Measured: 0 weeks and 12 weeks
Fasting Glucose
Change in fasting glucose
Measured: 0 weeks and 12 weeks
Change in Hemoglobin A1c
Change in percentage of Hemoglobin A1c
Measured: 0 weeks and 12 weeks
Change in Low Density Lipoprotein Levels
Change in low density lipoprotein levels from baseline to 12 weeks
Measured: 0 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start21 May 2018
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghana Gadgil, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334175
- Sponsor's protocol ID
- 4000-128070-125731P-44
- Status last verified
- Aug 2020
- First submitted
- 30 Oct 2017
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walnuts to Achieve Lasting NUTrition to Prevent Diabetes (WALNUT-Diabetes)
- ClinicalTrials.gov ID
- NCT03334175
- Acronym / sponsor ID
- 4000-128070-125731P-44
- Conditions
- PreDiabetes, Overweight and Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnuts Now | Experimental | Drug: WalnutsWill 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walnuts1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food. | Drug | Walnuts Now |
Primary outcome
Number of Participants Recruited and Retained
Time frame: 12 weeks
Number of participants recruited and retained
Adherence to the Intervention
Time frame: 12 weeks
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
Time frame: 12 weeks
Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant."
4 secondary outcomes
Change in Diet Quality
Time frame: 0 weeks and 12 weeks
Fasting Glucose
Time frame: 0 weeks and 12 weeks
Change in Hemoglobin A1c
Time frame: 0 weeks and 12 weeks
Change in Low Density Lipoprotein Levels
Time frame: 0 weeks and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghana Gadgil, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Walnuts in people with PreDiabetes and Overweight and Obesity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recruited and Retained (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.