NCT03334175

Walnuts to Achieve Lasting NUTrition to Prevent Diabetes

Completed Phase 1, PHASE2 Results posted Last updated 2 September 2020

What this trial tests

Phase 1, PHASE2 trial testing Walnuts in PreDiabetes in 18 participants. Completed in 5 August 2019.

Timeline

21 May 2018

Primary endpoint
5 August 2019

5 August 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	18
Start date	21 May 2018
Primary completion	5 August 2019
Estimated completion	5 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Walnuts — full drug profile →

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →
• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 65, any sex, with PreDiabetes or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Recruited and Retained Primary · 12 weeks

Number of participants recruited and retained

Group	Value	95% CI
Walnuts Now	8
Walnuts Later	9

Adherence to the Intervention Primary · 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.

Group	Value	95% CI
Walnuts Now	74.7	47 – 93

Palatability of Supplement Primary · 12 weeks

Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant."

Group	Value	95% CI
Walnuts Now	87	70 – 100

Change in Diet Quality Secondary · 0 weeks and 12 weeks

Change in diet quality measured by Healthy Eating Index-2010 Score (0 - 100). Higher scores indicate better diet quality.

Group	Value	95% CI
Walnuts Now	2.1	± 11.9
Walnuts Later	2.9	± 6.2

Fasting Glucose Secondary · 0 weeks and 12 weeks

Change in fasting glucose

Group	Value	95% CI
Walnuts Now	-4.75	± 9.8
Walnuts Later	1.2	± 7.5

Change in Hemoglobin A1c Secondary · 0 weeks and 12 weeks

Change in percentage of Hemoglobin A1c

Group	Value	95% CI
Walnuts Now	-0.05	± 0.13
Walnuts Later	-0.08	± 0.21

Change in Low Density Lipoprotein Levels Secondary · 0 weeks and 12 weeks

Change in low density lipoprotein levels from baseline to 12 weeks

Group	Value	95% CI
Walnuts Now	-8.4	± 15.5
Walnuts Later	-0.5	± 13.1

Number of Participants Who Had Plasma Metabolomics Performed Secondary · 0 weeks and 12 weeks

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.

Group	Value	95% CI
Walnuts Now	8
Walnuts Later	9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.