Diabetes MellitusNCT03224533
Walnut Consumption and Diabetes Risk
An observational study of Diabetes Mellitus, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Multiple NHANES surveys were combined and weighted to evaluate relationships between walnut consumption and type 2 diabetes mellitus using various independent measures of diabetes status and risk. After risks were ascertained, interactions with gender were analyzed. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diabetes Outcome
- How many people
- 34,121 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 30 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The National Health and Nutrition Examination Survey (NHANES) is a cross-sectional, probability survey administered to the US civilian population aged from 0 to 85 years. This study used continuous NHANES data collected from 1999 to 2014, covering eight cycles of data collection (N=82,091). Participants were excluded from analysis for being under 18 (N=34,735) and not having data on either day of the 24-hour food intake (N=6,533). In an attempt to have a control group free of nut consumers, individuals who consumed peanuts, but not other nuts on the day of recall, were excluded from the analysis (N=6,702). After exclusions, our analytic sample N was 34,121, representing a population size of approximately 176 million individuals.
Who may be able to join
- NHANES data from 1999-2014 with food recalls and dietary food intake
Who cannot join
- not having data on either day of the 24-hour food intake
- individuals who consumed peanuts, but not other nuts on the day of recall, were excluded from the analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Association Between Walnut Consumption and Diabetes Risk in NHANES May be Gender Sex Specific
Multiple NHANES surveys were combined and weighted to evaluate relationships between walnut consumption and type 2 diabetes mellitus using various independent measures of diabetes status and risk. After risks were ascertained, interactions with gender were analyzed.
Read the detailed description
Background. Dietary interventions and cohort studies of tree nuts lowering glucose levels for diabetes suggest a possible effect with walnuts. Objective. To examine the associations between walnut consumption and diabetes risk through data from the National Health and Nutrition Examination Survey (NHANES). Methods. NHANES survey data for 1999 through 2014 was pooled for adults with 24 hour recall dietary data. Risk of diabetes was based on self-report, medication use, fasting plasma glucose levels, and hemoglobin A1c (HbA1c) levels. Individuals were characterized as reporting consumption of walnuts, mixed 'nuts', or no nuts.
- Conditions
- Diabetes Mellitus
- Being tested
- Diabetes Outcome
- Keywords
- nut consumption, NHANES, epidemiology, plasma glucose, hemoglobin A1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes OutcomeDiagnostic test
based on self report definition, fasting plasma glucose, and hemoglobin A1c
| Study group | Role | What they receive |
|---|---|---|
| No Nuts | All other foods that did not include walnuts or other nuts were classified as "no nuts" (NN). Receives: Diagnostic Test: Diabetes Outcome | |
| Other Nuts | Foods codes describing nuts that are not walnuts (i.e. cashew nuts, pistachios, etc.) or nut-containing foods that do not commonly contain walnuts (e.g. granola) were classified as "other nuts" (ON). Receives: Diagnostic Test: Diabetes Outcome | |
| Walnuts with other nuts | food codes describing nut mixes and foods that commonly include walnuts were classified as "walnuts with other nuts" (WwON) Receives: Diagnostic Test: Diabetes Outcome | |
| Walnuts with high certainty | Foods consisting entirely or mostly of walnuts were classified as "walnuts with high certainty" (WwHC) Receives: Diagnostic Test: Diabetes Outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Outcome- self report
Based on self-report as told by a doctor
Measured: 1999-2014
Diabetes Outcome- Fasting Plasma Glucose
Based on FPG levels
Measured: 1999-2014
Diabetes Outcome- Hemoglobin A1c
Based on HbA1c levels
Measured: 1999-2014
Diabetes Outcome- Combined Definition
Based on both FPG and HbA1c levels
Measured: 1999-2014
Secondary outcomes (1)
Sex Interaction
based on the previously stated definition outcomes
Measured: 1999-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jun 2015
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Principal investigator, Lenore Arab, PhD, University of California, Los Angeles
- Investigators
- Lenore Arab, MSc, PhD, Principal investigator, David Geffen School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224533
- Sponsor's protocol ID
- WALNUT6DIABETES
- Status last verified
- Jul 2017
- First submitted
- 15 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brennan AM, Sweeney LL, Liu X, Mantzoros CS. Walnut consumption increases satiation but has no effect on insulin resistance or the metabolic profile over a 4-day period. Obesity (Silver Spring). 2010 Jun;18(6):1176-82. doi: 10.1038/oby.2009.409. Epub 2009 Nov 12.
PubMed 19910942Kalgaonkar S, Almario RU, Gurusinghe D, Garamendi EM, Buchan W, Kim K, Karakas SE. Differential effects of walnuts vs almonds on improving metabolic and endocrine parameters in PCOS. Eur J Clin Nutr. 2011 Mar;65(3):386-93. doi: 10.1038/ejcn.2010.266. Epub 2010 Dec 15.
PubMed 21157477Katz DL, Davidhi A, Ma Y, Kavak Y, Bifulco L, Njike VY. Effects of walnuts on endothelial function in overweight adults with visceral obesity: a randomized, controlled, crossover trial. J Am Coll Nutr. 2012 Dec;31(6):415-23. doi: 10.1080/07315724.2012.10720468.
PubMed 23756586Ma Y, Njike VY, Millet J, Dutta S, Doughty K, Treu JA, Katz DL. Effects of walnut consumption on endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial. Diabetes Care. 2010 Feb;33(2):227-32. doi: 10.2337/dc09-1156. Epub 2009 Oct 30.
PubMed 19880586Mukuddem-Petersen J, Stonehouse Oosthuizen W, Jerling JC, Hanekom SM, White Z. Effects of a high walnut and high cashew nut diet on selected markers of the metabolic syndrome: a controlled feeding trial. Br J Nutr. 2007 Jun;97(6):1144-53. doi: 10.1017/S0007114507682944. Epub 2007 Mar 7.
PubMed 17381974Tapsell LC, Batterham MJ, Teuss G, Tan SY, Dalton S, Quick CJ, Gillen LJ, Charlton KE. Long-term effects of increased dietary polyunsaturated fat from walnuts on metabolic parameters in type II diabetes. Eur J Clin Nutr. 2009 Aug;63(8):1008-15. doi: 10.1038/ejcn.2009.19. Epub 2009 Apr 8.
PubMed 19352378Tapsell LC, Gillen LJ, Patch CS, Batterham M, Owen A, Bare M, Kennedy M. Including walnuts in a low-fat/modified-fat diet improves HDL cholesterol-to-total cholesterol ratios in patients with type 2 diabetes. Diabetes Care. 2004 Dec;27(12):2777-83. doi: 10.2337/diacare.27.12.2777.
PubMed 15562184Wu L, Piotrowski K, Rau T, Waldmann E, Broedl UC, Demmelmair H, Koletzko B, Stark RG, Nagel JM, Mantzoros CS, Parhofer KG. Walnut-enriched diet reduces fasting non-HDL-cholesterol and apolipoprotein B in healthy Caucasian subjects: a randomized controlled cross-over clinical trial. Metabolism. 2014 Mar;63(3):382-91. doi: 10.1016/j.metabol.2013.11.005. Epub 2013 Nov 12.
PubMed 24360749Moravej H, Salehi A, Razavi Z, Moein MR, Etemadfard H, Karami F, Ghahremani F. Chemical Composition and the Effect of Walnut Hydrosol on Glycemic Control of Patients With Type 1 Diabetes. Int J Endocrinol Metab. 2016 Jan 30;14(1):e34726. doi: 10.5812/ijem.34726. eCollection 2016 Jan.
PubMed 27335580Bullard KM, Ali MK, Imperatore G, Geiss LS, Saydah SH, Albu JB, Cowie CC, Sohler N, Albright A, Gregg EW. Receipt of Glucose Testing and Performance of Two US Diabetes Screening Guidelines, 2007-2012. PLoS One. 2015 Apr 30;10(4):e0125249. doi: 10.1371/journal.pone.0125249. eCollection 2015.
PubMed 25928306Guo K, Zhou Z, Jiang Y, Li W, Li Y. Meta-analysis of prospective studies on the effects of nut consumption on hypertension and type 2 diabetes mellitus. J Diabetes. 2015 Mar;7(2):202-12. doi: 10.1111/1753-0407.12173. Epub 2014 Jul 29.
PubMed 24893671Luo C, Zhang Y, Ding Y, Shan Z, Chen S, Yu M, Hu FB, Liu L. Nut consumption and risk of type 2 diabetes, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis. Am J Clin Nutr. 2014 Jul;100(1):256-69. doi: 10.3945/ajcn.113.076109. Epub 2014 May 21.
PubMed 24847854Zhou D, Yu H, He F, Reilly KH, Zhang J, Li S, Zhang T, Wang B, Ding Y, Xi B. Nut consumption in relation to cardiovascular disease risk and type 2 diabetes: a systematic review and meta-analysis of prospective studies. Am J Clin Nutr. 2014 Jul;100(1):270-7. doi: 10.3945/ajcn.113.079152. Epub 2014 May 7.
PubMed 24808491Pan A, Sun Q, Manson JE, Willett WC, Hu FB. Walnut consumption is associated with lower risk of type 2 diabetes in women. J Nutr. 2013 Apr;143(4):512-8. doi: 10.3945/jn.112.172171. Epub 2013 Feb 20.
PubMed 23427333Guo F, Moellering DR, Garvey WT. Use of HbA1c for diagnoses of diabetes and prediabetes: comparison with diagnoses based on fasting and 2-hr glucose values and effects of gender, race, and age. Metab Syndr Relat Disord. 2014 Jun;12(5):258-68. doi: 10.1089/met.2013.0128. Epub 2014 Feb 10.
PubMed 24512556
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Walnut Consumption and Diabetes Risk in NHANES May be Gender Sex Specific
- ClinicalTrials.gov ID
- NCT03224533
- Acronym / sponsor ID
- WALNUT6DIABETES
- Conditions
- Diabetes Mellitus
- Keywords
- nut consumption, NHANES, epidemiology, plasma glucose, hemoglobin A1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34,121 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple NHANES surveys were combined and weighted to evaluate relationships between walnut consumption and type 2 diabetes mellitus using various independent measures of diabetes status and risk. After risks were ascertained, interactions with gender were analyzed.
Detailed description
Background. Dietary interventions and cohort studies of tree nuts lowering glucose levels for diabetes suggest a possible effect with walnuts. Objective. To examine the associations between walnut consumption and diabetes risk through data from the National Health and Nutrition Examination Survey (NHANES). Methods. NHANES survey data for 1999 through 2014 was pooled for adults with 24 hour recall dietary data. Risk of diabetes was based on self-report, medication use, fasting plasma glucose levels, and hemoglobin A1c (HbA1c) levels. Individuals were characterized as reporting consumption of walnuts, mixed 'nuts', or no nuts.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Nuts | – | Diagnostic Test: Diabetes OutcomeAll other foods that did not include walnuts or other nuts were classified as "no nuts" (NN). |
| Other Nuts | – | Diagnostic Test: Diabetes OutcomeFoods codes describing nuts that are not walnuts (i.e. cashew nuts, pistachios, etc.) or nut-containing foods that do not commonly contain walnuts (e.g. granola) were classified as "other nuts" (ON). |
| Walnuts with other nuts | – | Diagnostic Test: Diabetes Outcomefood codes describing nut mixes and foods that commonly include walnuts were classified as "walnuts with other nuts" (WwON) |
| Walnuts with high certainty | – | Diagnostic Test: Diabetes OutcomeFoods consisting entirely or mostly of walnuts were classified as "walnuts with high certainty" (WwHC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The National Health and Nutrition Examination Survey (NHANES) is a cross-sectional, probability survey administered to the US civilian population aged from 0 to 85 years. This study used continuous NHANES data collected from 1999 to 2014, covering eight cycles of data collection (N=82,091). Participants were excluded from analysis for being under 18 (N=34,735) and not having data on either day of the 24-hour food intake (N=6,533). In an attempt to have a control group free of nut consumers, individuals who consumed peanuts, but not other nuts on the day of recall, were excluded from the analysis (N=6,702). After exclusions, our analytic sample N was 34,121, representing a population size of approximately 176 million individuals.
Key inclusion criteria (1 listed)
- NHANES data from 1999-2014 with food recalls and dietary food intake
Key exclusion criteria (2 listed)
- not having data on either day of the 24-hour food intake
- individuals who consumed peanuts, but not other nuts on the day of recall, were excluded from the analysis
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 |
|---|---|---|
| Diabetes Outcomebased on self report definition, fasting plasma glucose, and hemoglobin A1c | Diagnostic test | No Nuts, Other Nuts, Walnuts with high certainty, Walnuts with other nuts |
Primary outcome
Diabetes Outcome- self report
Time frame: 1999-2014
Based on self-report as told by a doctor
Diabetes Outcome- Fasting Plasma Glucose
Time frame: 1999-2014
Based on FPG levels
Diabetes Outcome- Hemoglobin A1c
Time frame: 1999-2014
Based on HbA1c levels
Diabetes Outcome- Combined Definition
Time frame: 1999-2014
Based on both FPG and HbA1c levels
1 secondary outcome
Sex Interaction
Time frame: 1999-2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 19910942Brennan AM, Sweeney LL, Liu X, Mantzoros CS. Walnut consumption increases satiation but has no effect on insulin resistance or the metabolic profile over a 4-day period. Obesity (Silver Spring). 2010 Jun;18(6):1176-82. doi: 10.1038/oby.2009.409. Epub 2009 Nov 12.
- Background: PubMed 21157477Kalgaonkar S, Almario RU, Gurusinghe D, Garamendi EM, Buchan W, Kim K, Karakas SE. Differential effects of walnuts vs almonds on improving metabolic and endocrine parameters in PCOS. Eur J Clin Nutr. 2011 Mar;65(3):386-93. doi: 10.1038/ejcn.2010.266. Epub 2010 Dec 15.
- Background: PubMed 23756586Katz DL, Davidhi A, Ma Y, Kavak Y, Bifulco L, Njike VY. Effects of walnuts on endothelial function in overweight adults with visceral obesity: a randomized, controlled, crossover trial. J Am Coll Nutr. 2012 Dec;31(6):415-23. doi: 10.1080/07315724.2012.10720468.
- Background: PubMed 19880586Ma Y, Njike VY, Millet J, Dutta S, Doughty K, Treu JA, Katz DL. Effects of walnut consumption on endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial. Diabetes Care. 2010 Feb;33(2):227-32. doi: 10.2337/dc09-1156. Epub 2009 Oct 30.
- Background: PubMed 17381974Mukuddem-Petersen J, Stonehouse Oosthuizen W, Jerling JC, Hanekom SM, White Z. Effects of a high walnut and high cashew nut diet on selected markers of the metabolic syndrome: a controlled feeding trial. Br J Nutr. 2007 Jun;97(6):1144-53. doi: 10.1017/S0007114507682944. Epub 2007 Mar 7.
- Background: PubMed 19352378Tapsell LC, Batterham MJ, Teuss G, Tan SY, Dalton S, Quick CJ, Gillen LJ, Charlton KE. Long-term effects of increased dietary polyunsaturated fat from walnuts on metabolic parameters in type II diabetes. Eur J Clin Nutr. 2009 Aug;63(8):1008-15. doi: 10.1038/ejcn.2009.19. Epub 2009 Apr 8.
- Background: PubMed 15562184Tapsell LC, Gillen LJ, Patch CS, Batterham M, Owen A, Bare M, Kennedy M. Including walnuts in a low-fat/modified-fat diet improves HDL cholesterol-to-total cholesterol ratios in patients with type 2 diabetes. Diabetes Care. 2004 Dec;27(12):2777-83. doi: 10.2337/diacare.27.12.2777.
- Background: PubMed 24360749Wu L, Piotrowski K, Rau T, Waldmann E, Broedl UC, Demmelmair H, Koletzko B, Stark RG, Nagel JM, Mantzoros CS, Parhofer KG. Walnut-enriched diet reduces fasting non-HDL-cholesterol and apolipoprotein B in healthy Caucasian subjects: a randomized controlled cross-over clinical trial. Metabolism. 2014 Mar;63(3):382-91. doi: 10.1016/j.metabol.2013.11.005. Epub 2013 Nov 12.
- Background: PubMed 27335580Moravej H, Salehi A, Razavi Z, Moein MR, Etemadfard H, Karami F, Ghahremani F. Chemical Composition and the Effect of Walnut Hydrosol on Glycemic Control of Patients With Type 1 Diabetes. Int J Endocrinol Metab. 2016 Jan 30;14(1):e34726. doi: 10.5812/ijem.34726. eCollection 2016 Jan.
- Background: PubMed 25928306Bullard KM, Ali MK, Imperatore G, Geiss LS, Saydah SH, Albu JB, Cowie CC, Sohler N, Albright A, Gregg EW. Receipt of Glucose Testing and Performance of Two US Diabetes Screening Guidelines, 2007-2012. PLoS One. 2015 Apr 30;10(4):e0125249. doi: 10.1371/journal.pone.0125249. eCollection 2015.
- Background: PubMed 24893671Guo K, Zhou Z, Jiang Y, Li W, Li Y. Meta-analysis of prospective studies on the effects of nut consumption on hypertension and type 2 diabetes mellitus. J Diabetes. 2015 Mar;7(2):202-12. doi: 10.1111/1753-0407.12173. Epub 2014 Jul 29.
- Background: PubMed 24847854Luo C, Zhang Y, Ding Y, Shan Z, Chen S, Yu M, Hu FB, Liu L. Nut consumption and risk of type 2 diabetes, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis. Am J Clin Nutr. 2014 Jul;100(1):256-69. doi: 10.3945/ajcn.113.076109. Epub 2014 May 21.
- Individual participant dataSharing planned: No
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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.
Lenore Arab, MSc, PhD principal investigator
David Geffen School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by University of California, Los Angeles 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 1 inclusion and 2 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 21 Jul 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diabetes Outcome- self report (time frame: 1999-2014). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224533, which also lists 15 linked publications.
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 21 Jul 2017.