Walnuts to Achieve Lasting NUTrition to Prevent Diabetes
Kata kunci
Abstrak
tanggal
Terakhir Diverifikasi: | 08/31/2019 |
Pertama Dikirim: | 10/29/2017 |
Perkiraan Pendaftaran Telah Dikirim: | 11/01/2017 |
Pertama Diposting: | 11/06/2017 |
Pembaruan Terakhir Dikirim: | 09/29/2019 |
Pembaruan Terakhir Diposting: | 10/01/2019 |
Tanggal Mulai Studi Sebenarnya: | 05/20/2018 |
Perkiraan Tanggal Penyelesaian Utama: | 08/04/2019 |
Perkiraan Tanggal Penyelesaian Studi: | 08/04/2019 |
Kondisi atau penyakit
Intervensi / pengobatan
Drug: Walnuts Now
Tahap
Kelompok Lengan
Lengan | Intervensi / pengobatan |
---|---|
Experimental: Walnuts Now Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention. | Drug: Walnuts Now 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food. |
No Intervention: Walnuts Later 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. |
Kriteria kelayakan
Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
Jenis Kelamin yang Layak untuk Belajar | All |
Menerima Relawan Sehat | Iya |
Kriteria | 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 |
Hasil
Ukuran Hasil Utama
1. Number of participants recruited and retained [12 weeks]
2. Adherence to the intervention [12 weeks]
Ukuran Hasil Sekunder
1. Diet quality [0 weeks and 12 weeks]
2. Fasting glucose [0 weeks and 12 weeks]
3. A1c [0 weeks and 12 weeks]
4. Lipids [0 weeks and 12 weeks]
Ukuran Hasil Lainnya
1. Metabolomics [0 wees and 12 weeks]