DiabetesWalnut3NCT02330848
Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures
A study testing Walnut Ad libitum diet in people with Diabetes, run by Griffin Hospital at 1 site in United States.
Trial summary
Proposed is a randomized, controlled, modified Latin square parallel design study with two treatment arms to examine walnut consumption effects on diet quality, body composition, and markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Walnut Ad libitum diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2014
- Phase
- Interventional
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female age 25-75 years;
- Non-smoker;
- High risk for diabetes, defined as meeting at least one of the criteria listed below:
- Overweight with increased waist circumference; b.Pre-diabetes: fasting blood glucose >100mg/dL and <126mg/dL or HbA1C 5.7-6.4 % c. Metabolic syndrome, i.e. meet three out of five of the following criteria: i.Blood pressure >130/85 mmHg or currently taking antihypertensive medication; ii. Fasting plasma glucose (FPG) >100 mg/dL (6.1 mmol/L); iii.Serum triglycerides level (TG)>150 mg/dL (1.69 mmol/L); iv. High-density lipoprotein (HDL) cholesterol < 40 mg/dL (1.04 mmol/L) in men, and < 50 mg/dL (1.29 mmol/L) in women; v. Overweight (BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women.
Who cannot join
- Allergy to walnuts or any other nuts;
- Anticipated inability to complete study protocol for any reason;
- Current eating disorder;
- Restricted diets by choice (i.e., vegetarian, vegan);
- Receiving pharmacotherapy for obesity, including appetite suppressant
- Unstable use of lipid-lowering, antihypertensive medications or aspirin (i.e. dose has changed in the three months prior to enrollment) or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning;
Show all 20Show fewer
- Regular use of high doses of vitamin E (>400IU/day) or vitamin C (>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and fiber supplement unless welling to discontinue supplementation for the study duration.
- Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators);
- Diagnosed diabetes;
- Diagnosed sleep apnea;
- Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis);
- Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin;
- Regular exercise defined as participation in moderate-intensity exercise > 150 minutes/week.
- Substance abuse (chronic alcoholism, other chemical dependency)
- Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
- Women who get Depo-Provera shots
- Women who are pregnant or lactating
- Women who are currently on hormone replacement therapy
- Substance abuse (chronic alcoholism, other chemical dependency)
- Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418
About this study
Proposed is a randomized, controlled, modified Latin square parallel design study with two treatment arms to examine walnut consumption effects on diet quality, body composition, and markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A modified crossover design (Latin square)27-29 will allow for both paired and unpaired analyses.
Read the detailed description
Specific Aims
- To determine the effects of a walnut-included diet (with or without caloric intake adjustment) versus walnut-excluded diet on diet quality in adults at risk for diabetes. Specifically, to show that a walnut-included diet, as compared to a walnut-excluded diet will improve overall diet quality as measured by the Alternative Healthy Eating Index in adults at risk for diabetes.
- To determine the effects of a walnut-included diet (with or without caloric intake adjustment) versus walnut-excluded diet on body composition in adults at risk for diabetes. Specifically, to show that a walnut-included diet, as compared to a walnut-excluded diet for 6 months will improve body fat percentage in adults at risk for diabetes.
- To assess the effects of a walnut-included diet (with or without caloric intake adjustment) for a 6-month period on endothelial function, lipid panel levels, fasting glucose level, fasting insulin level and anthropometric measures in adults at risk for diabetes. Specifically, to show clinically meaningful improvement in endothelial function, lipid panel, fasting blood glucose, hemoglobin A1c (HbA1c), anthropometric measures and endothelial function with inclusion of walnuts in the diet in adults at risk for diabetes.
Hypotheses
- A walnut-included diet with or without dietary counseling to adjust caloric intake will improve diet quality in adults at risk for diabetes.
- A walnut-included diet for 6 months with or without dietary counseling to adjust caloric intake will improve body composition in adults at risk for diabetes.
- A walnut-included diet with or without dietary counseling to adjust caloric intake will improve lipid panel, fasting blood glucose, hemoglobin A1c, endothelial function and anthropometric measures in adults at risk for diabetes.
- Controlling calorie intake to keep it constant with the addition of walnuts to the diet will enhance the beneficial effects of walnut ingestion on diet quality, body composition, and vascular function.
- Conditions
- Diabetes
- Being tested
- Walnut Ad libitum diet, Walnut Calorie controlled
- Keywords
- Obesity, Walnuts, Endothelial Function, Adults at risk
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut Ad libitum dietDietary supplement
Participants will be provided 392 grams of walnuts per week (56g or 2 oz/day) to include in their diet. Their calorie intake will not be subsequently monitored or regulated, and thus will be allowed to float ad libitum
Walnut Calorie controlledDietary supplement
The intervention group participants will meet with a registered dietitian and receive instructions and recipes for inclusion of 392 grams of walnuts per week (56g or 2 oz/day) in their meal plan for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Walnut Ad libitum diet | Active comparator | Participants will be provided 392 grams of walnuts per week (56g or 2 oz/day) to include in their diet. Their calorie intake will not be subsequently monitored or regulated, and thus will be allowed to float ad libitum. Receives: Dietary Supplement: Walnut Ad libitum diet |
| Walnut Calorie Controlled | Active comparator | The intervention group participants will meet with a registered dietitian and receive instructions and recipes for inclusion of 392 grams of walnuts per week (56g or 2 oz/day) in their meal plan. Participants will receive on-going instruction to preserve an isocaloric condition after the addition of walnuts. The study dietitian will customize dietary adjustments to make room for walnuts in the diet, while accommodating the priorities of each study participant. The general approach will emphasize general reduction in portion sizes; participants will also receive advice, based on baseline dietary intake analysis, of food eliminations that they might want to consider. Receives: Dietary Supplement: Walnut Calorie controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Quality assessed using the Alternative Healthy Eating Index (AHEI)
To help the study team track any variation in dietary pattern over the course of the study, all participants will be asked at five different time points to provide information on the foods and beverages that they consumed. A 3-day food diary record will be collected along with a one 24-hour recall using a web-based Automated Self-Administered 24-Hour Recall (ASA24) (available from the National Cancer Institute at http://riskfactor.cancer.gov/tools/instruments/asa24/) which will guide them through the process of completing the recall data. Diet quality will be assessed using the Alternative Healthy Eating Index (AHEI).
Measured: 6 months
Secondary outcomes (7)
Body Composition measured using bioelectrical impedance analysis and SC-240 Body Composition Analyzer
Body composition will be measured using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat. The Tanita SC-240 Body Composition Analyzer will be used to measure body composition. The SC-240 Body Composition Analyzer measures weight and calculates body fat% and total body water% in addition to BMI.
Measured: 6 months
Endothelial Function (EF) Assessment using the brachial artery reactivity studies (BARS) methodology
The brachial artery reactivity studies (BARS) methodology employed is as described in the published, "Guidelines for Ultrasound Assessment of Endothelial-dependent Flow-mediated Vasodilation of the Brachial Artery." The measure of interest is flow-mediated dilatation of the brachial artery.
Measured: 6 months
Anthropometric Measures
Body weight will be measured using a calibrated digital scale while height will be measured by using a calibrated stadiometer. Body mass index (BMI) will be calculated as weight (kg) divided by height in meters (m) squared. Waist circumference will be measured using guidelines of the National Obesity Expert Panel Report.
Measured: 6 months
Lipid Profile
The lipid profile is determined as follows: Total cholesterol (Tchol), triglycerides (TRIG), and high-density lipoprotein (HDL) are obtained by direct measurements. Very-low-density lipoprotein (VLDL) and low-density-lipoprotein (LDL) are obtained by calculation: VLDL = TRIG/5; and LDL = Tchol - (VLDL + HDL). HDL:Tchol ratio will be used to evaluate the impact of walnuts on the lipid profile.
Measured: 6 months
Fasting Blood Glucose
Measured: 6 months
HbA1C
Measured: 6 months
Physical Activity assessed by the International Physical Activity Questionnaire (IPAQ)
Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ). The IPAQ is a valid and reliable tool to assess physical activity in adults. It is a more comprehensive tool containing information on weekly activities in household and yard-work activities, occupational activity, transport, leisure time physical activity and sedentary behavior.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David L. Katz, MD, MPH, Principal investigator, Yale-Griffin Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330848
- Sponsor's protocol ID
- 2011-16
- Acronym
- Walnut3
- Status last verified
- Mar 2020
- First submitted
- 2 Apr 2014
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Njike VY, Costales VC, Petraro P, Annam R, Yarandi N, Katz DL. The Resulting Variation in Nutrient Intake With the Inclusion of Walnuts in the Diets of Adults at Risk for Type 2 Diabetes: A Randomized, Controlled, Crossover Trial. Am J Health Promot. 2019 Mar;33(3):430-438. doi: 10.1177/0890117118791120. Epub 2018 Aug 1.
PubMed 30068215Njike VY, Yarandi N, Petraro P, Ayettey RG, Treu JA, Katz DL. Inclusion of walnut in the diets of adults at risk for type 2 diabetes and their dietary pattern changes: a randomized, controlled, cross-over trial. BMJ Open Diabetes Res Care. 2016 Oct 19;4(1):e000293. doi: 10.1136/bmjdrc-2016-000293. eCollection 2016.
PubMed 27843557Njike VY, Ayettey R, Petraro P, Treu JA, Katz DL. Walnut ingestion in adults at risk for diabetes: effects on body composition, diet quality, and cardiac risk measures. BMJ Open Diabetes Res Care. 2015 Oct 19;3(1):e000115. doi: 10.1136/bmjdrc-2015-000115. eCollection 2015.
PubMed 26688734
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures
- ClinicalTrials.gov ID
- NCT02330848
- Acronym / sponsor ID
- Walnut3 / 2011-16
- Conditions
- Diabetes
- Keywords
- Obesity, Walnuts, Endothelial Function, Adults at risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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.
Proposed is a randomized, controlled, modified Latin square parallel design study with two treatment arms to examine walnut consumption effects on diet quality, body composition, and markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A modified crossover design (Latin square)27-29 will allow for both paired and unpaired analyses.
Detailed description
Specific Aims
- To determine the effects of a walnut-included diet (with or without caloric intake adjustment) versus walnut-excluded diet on diet quality in adults at risk for diabetes. Specifically, to show that a walnut-included diet, as compared to a walnut-excluded diet will improve overall diet quality as measured by the Alternative Healthy Eating Index in adults at risk for diabetes.
- To determine the effects of a walnut-included diet (with or without caloric intake adjustment) versus walnut-excluded diet on body composition in adults at risk for diabetes. Specifically, to show that a walnut-included diet, as compared to a walnut-excluded diet for 6 months will improve body fat percentage in adults at risk for diabetes.
- To assess the effects of a walnut-included diet (with or without caloric intake adjustment) for a 6-month period on endothelial function, lipid panel levels, fasting glucose level, fasting insulin level and anthropometric measures in adults at risk for diabetes. Specifically, to show clinically meaningful improvement in endothelial function, lipid panel, fasting blood glucose, hemoglobin A1c (HbA1c), anthropometric measures and endothelial function with inclusion of walnuts in the diet in adults at risk for diabetes.
Hypotheses
- A walnut-included diet with or without dietary counseling to adjust caloric intake will improve diet quality in adults at risk for diabetes.
- A walnut-included diet for 6 months with or without dietary counseling to adjust caloric intake will improve body composition in adults at risk for diabetes.
- A walnut-included diet with or without dietary counseling to adjust caloric intake will improve lipid panel, fasting blood glucose, hemoglobin A1c, endothelial function and anthropometric measures in adults at risk for diabetes.
- Controlling calorie intake to keep it constant with the addition of walnuts to the diet will enhance the beneficial effects of walnut ingestion on diet quality, body composition, and vascular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnut Ad libitum diet | Active comparator | Dietary Supplement: Walnut Ad libitum dietParticipants will be provided 392 grams of walnuts per week (56g or 2 oz/day) to include in their diet. Their calorie intake will not be subsequently monitored or regulated, and thus will be allowed to float ad libitum. |
| Walnut Calorie Controlled | Active comparator | Dietary Supplement: Walnut Calorie controlledThe intervention group participants will meet with a registered dietitian and receive instructions and recipes for inclusion of 392 grams of walnuts per week (56g or 2 oz/day) in their meal plan. Participants will receive on-going instruction to preserve an isocaloric condition after the addition of walnuts. The study dietitian will customize dietary adjustments to make room for walnuts in the diet, while accommodating the priorities of each study participant. The general approach will emphasize general reduction in portion sizes; participants will also receive advice, based on baseline dietary intake analysis, of food eliminations that they might want to consider. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female age 25-75 years;
- Non-smoker;
- High risk for diabetes, defined as meeting at least one of the criteria listed below:
Key exclusion criteria (20 listed)
- Allergy to walnuts or any other nuts;
- Anticipated inability to complete study protocol for any reason;
- Current eating disorder;
- Restricted diets by choice (i.e., vegetarian, vegan);
- Receiving pharmacotherapy for obesity, including appetite suppressant
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 |
|---|---|---|
| Walnut Ad libitum dietParticipants will be provided 392 grams of walnuts per week (56g or 2 oz/day) to include in their diet. Their calorie intake will not be subsequently monitored or regulated, and thus will be allowed to float ad libitum | Dietary supplement | Walnut Ad libitum diet |
| Walnut Calorie controlledThe intervention group participants will meet with a registered dietitian and receive instructions and recipes for inclusion of 392 grams of walnuts per week (56g or 2 oz/day) in their meal plan for 6 months. | Dietary supplement | Walnut Calorie Controlled |
Primary outcome
Diet Quality assessed using the Alternative Healthy Eating Index (AHEI)
Time frame: 6 months
To help the study team track any variation in dietary pattern over the course of the study, all participants will be asked at five different time points to provide information on the foods and beverages that they consumed. A 3-day food diary record will be collected along with a one 24-hour recall using a web-based Automated Self-Administered 24-Hour Recall (ASA24) (available from the National Cancer Institute at http://riskfactor.cancer.gov/tools/instruments/asa24/) which will guide them through the process of completing the recall data. Diet quality will be assessed using the Alternative Healthy Eating Index (AHEI).
7 secondary outcomes
Body Composition measured using bioelectrical impedance analysis and SC-240 Body Composition Analyzer
Time frame: 6 months
Endothelial Function (EF) Assessment using the brachial artery reactivity studies (BARS) methodology
Time frame: 6 months
Anthropometric Measures
Time frame: 6 months
Lipid Profile
Time frame: 6 months
Fasting Blood Glucose
Time frame: 6 months
HbA1C
Time frame: 6 months
Physical Activity assessed by the International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
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 26 Mar 2020.
- Derived from this study: PubMed 30068215Njike VY, Costales VC, Petraro P, Annam R, Yarandi N, Katz DL. The Resulting Variation in Nutrient Intake With the Inclusion of Walnuts in the Diets of Adults at Risk for Type 2 Diabetes: A Randomized, Controlled, Crossover Trial. Am J Health Promot. 2019 Mar;33(3):430-438. doi: 10.1177/0890117118791120. Epub 2018 Aug 1.
- Derived from this study: PubMed 27843557Njike VY, Yarandi N, Petraro P, Ayettey RG, Treu JA, Katz DL. Inclusion of walnut in the diets of adults at risk for type 2 diabetes and their dietary pattern changes: a randomized, controlled, cross-over trial. BMJ Open Diabetes Res Care. 2016 Oct 19;4(1):e000293. doi: 10.1136/bmjdrc-2016-000293. eCollection 2016.
- Derived from this study: PubMed 26688734Njike VY, Ayettey R, Petraro P, Treu JA, Katz DL. Walnut ingestion in adults at risk for diabetes: effects on body composition, diet quality, and cardiac risk measures. BMJ Open Diabetes Res Care. 2015 Oct 19;3(1):e000115. doi: 10.1136/bmjdrc-2015-000115. eCollection 2015.
- 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.
David L. Katz, MD, MPH principal investigator
Yale-Griffin Prevention Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut Ad libitum diet in people with Diabetes, run by Griffin Hospital 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 4 inclusion and 20 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 26 Mar 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.
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?
Diet Quality assessed using the Alternative Healthy Eating Index (AHEI) (time frame: 6 months). 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 NCT02330848, which also lists 3 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 26 Mar 2020.