Type 2 DiabetesNCT00937222
Effects of Peanut and Peanut Butter Consumption on Blood Lipids and Glycemic Control in Adults With Type 2 Diabetes
A study testing Peanuts and peanut butter in people with Type 2 Diabetes, run by Loma Linda University at 1 site in United States.
Trial summary
Peanuts and peanut butter contain high levels of monounsaturated fat (MUFA), arginine, fiber, phytosterols, resveratrol and vitamin E that have the potential to reduce cardiovascular disease (CVD) risk through improved blood glucose control and favorable modification of blood lipids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Peanuts and peanut butter
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a medical diagnosis of diabetes for at least 6 months
- HbA1c < 9%
- Age greater than 18 years
- Resident of Loma Linda, California area
Who cannot join
- Allergy to peanuts
- Smokers
- History of irritable bowel disease or diverticulitis
- Statin therapy (unless stable statin dose for 3 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center Diabetes Treatment Center
Loma Linda, California, 92350
About this study
Official title: Effects of Peanut and Peanut Butter Consumption on Blood Lipids and Glycemic Control in Adults Ith Type 2 Diabetes
Peanuts and peanut butter contain high levels of monounsaturated fat (MUFA), arginine, fiber, phytosterols, resveratrol and vitamin E that have the potential to reduce cardiovascular disease (CVD) risk through improved blood glucose control and favorable modification of blood lipids. When substituted for saturated fat in the diet, MUFA may have important metabolic benefits for persons with diabetes. Therefore, the investigators propose to study the effects of a peanut and peanut butter-enriched diet on markers of CVD risk factors in free-living adults with diabetes residing in Southern California. This study's primary clinical outcome will be high-density lipoprotein (HDL) - cholesterol. Secondary outcomes will include additional serum lipids (total cholesterol, low-density lipoprotein (LDL) - cholesterol and triacylglycerol), glucose, HbA1c, and anthropometry (body weight, body composition and waist circumference). This study will provide vital information about the role of peanuts and peanut butter in modulating blood glucose homeostasis and CVD risk factors among adults with diabetes.
Read the detailed description
This will be a parallel randomized controlled intervention study on free-living adults with diabetes. The study duration will be 6 months. Participants will be randomized to receive one of two dietary approaches (moderate fat, control; and, moderate fat inclusive of 32 g peanuts or 2 Tbsp. peanut butter per day, intervention) to an ADA meal plan targeting a profile of 35% fat, 45% CHO and 20% protein. A supply of peanuts and peanut butter from the National Peanut Board will be provided to participants assigned to the intervention group at clinic visits. The peanuts and peanut butter will be consumed as part of the participant's customary meals and snacks. In light of ADA's prior recommendation to derive 60 to 70% of energy intake from CHO and MUFA, the peanuts and peanut butter will provide an enhanced proportion of energy from MUFA (total fat content of peanuts by compositional weight is 22% and 52% of the total fat is MUFA).
An experienced Registered Dietitian and Certified Diabetes Educator will oversee the dietary advice provided to each of the two groups. All participants will be provided with an individualized portion-controlled meal plan using the ADA food exchange lists and possibly modified fat instruction on fatty acid considerations and inclusion of peanuts and peanut butter. Dietary compliance, especially the intake of peanuts and peanut butter, will be measured by six 24-hour recalls without notice (telephone interview by a dietitian on what was consumed the previous day). Participants will be requested to maintain their activities and other lifestyle habits and to record in diaries provided to them any signs of illness, medications used, and any deviation from their prescribed diet. The investigators will examine diaries at the clinic visits. No major deviations from the protocol will be tolerated.
Less than 100 ml of blood will be drawn from each participant at baseline (week 0), week 12 and week 24. All blood drawings will be performed at Loma Linda University Medical Center. Participants will report to the laboratory on the assigned days after fasting for a minimum of 12 hours. Body weight and body composition measurements (percent body fat, fat free mass, total body water) will be obtained at each clinic visit using an internally calibrated segmental bioelectrical impedance analysis device (Tanita®, Arlington Heights, IL).
- Conditions
- Type 2 Diabetes
- Being tested
- Peanuts and peanut butter
- Keywords
- diabetes, cholesterol, peanuts, peanut butter, dietary intervention, HDL cholesterol
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanuts and peanut butterDietary supplement
Peanuts and peanut butter
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is HDL-C
Measured: 12 weeks and 24 weeks
Secondary outcomes (1)
Serum lipids, glucose, HbA1c, anthropometrics and blood pressure
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- National Peanut Board
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
- Investigators
- Joan Sabaté, MD, DrPh, Principal investigator, Chair, Department of NutritionMichelle Wien, DrPH, Study director, Assistant Professor, Department of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937222
- Sponsor's protocol ID
- 59049
- Status last verified
- Jun 2012
- First submitted
- 8 Jul 2009
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wien M, Oda K, Sabate J. A randomized controlled trial to evaluate the effect of incorporating peanuts into an American Diabetes Association meal plan on the nutrient profile of the total diet and cardiometabolic parameters of adults with type 2 diabetes. Nutr J. 2014 Jan 22;13:10. doi: 10.1186/1475-2891-13-10.
PubMed 24450471
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peanut and Peanut Butter Consumption on Blood Lipids and Glycemic Control in Adults Ith Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00937222
- Acronym / sponsor ID
- 59049
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, cholesterol, peanuts, peanut butter, dietary intervention, HDL cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- National Peanut Board
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Jul 2009 (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.
Peanuts and peanut butter contain high levels of monounsaturated fat (MUFA), arginine, fiber, phytosterols, resveratrol and vitamin E that have the potential to reduce cardiovascular disease (CVD) risk through improved blood glucose control and favorable modification of blood lipids. When substituted for saturated fat in the diet, MUFA may have important metabolic benefits for persons with diabetes. Therefore, the investigators propose to study the effects of a peanut and peanut butter-enriched diet on markers of CVD risk factors in free-living adults with diabetes residing in Southern California. This study's primary clinical outcome will be high-density lipoprotein (HDL) - cholesterol. Secondary outcomes will include additional serum lipids (total cholesterol, low-density lipoprotein (LDL) - cholesterol and triacylglycerol), glucose, HbA1c, and anthropometry (body weight, body composition and waist circumference). This study will provide vital information about the role of peanuts and peanut butter in modulating blood glucose homeostasis and CVD risk factors among adults with diabetes.
Detailed description
This will be a parallel randomized controlled intervention study on free-living adults with diabetes. The study duration will be 6 months. Participants will be randomized to receive one of two dietary approaches (moderate fat, control; and, moderate fat inclusive of 32 g peanuts or 2 Tbsp. peanut butter per day, intervention) to an ADA meal plan targeting a profile of 35% fat, 45% CHO and 20% protein. A supply of peanuts and peanut butter from the National Peanut Board will be provided to participants assigned to the intervention group at clinic visits. The peanuts and peanut butter will be consumed as part of the participant's customary meals and snacks. In light of ADA's prior recommendation to derive 60 to 70% of energy intake from CHO and MUFA, the peanuts and peanut butter will provide an enhanced proportion of energy from MUFA (total fat content of peanuts by compositional weight is 22% and 52% of the total fat is MUFA).
An experienced Registered Dietitian and Certified Diabetes Educator will oversee the dietary advice provided to each of the two groups. All participants will be provided with an individualized portion-controlled meal plan using the ADA food exchange lists and possibly modified fat instruction on fatty acid considerations and inclusion of peanuts and peanut butter. Dietary compliance, especially the intake of peanuts and peanut butter, will be measured by six 24-hour recalls without notice (telephone interview by a dietitian on what was consumed the previous day). Participants will be requested to maintain their activities and other lifestyle habits and to record in diaries provided to them any signs of illness, medications used, and any deviation from their prescribed diet. The investigators will examine diaries at the clinic visits. No major deviations from the protocol will be tolerated.
Less than 100 ml of blood will be drawn from each participant at baseline (week 0), week 12 and week 24. All blood drawings will be performed at Loma Linda University Medical Center. Participants will report to the laboratory on the assigned days after fasting for a minimum of 12 hours. Body weight and body composition measurements (percent body fat, fat free mass, total body water) will be obtained at each clinic visit using an internally calibrated segmental bioelectrical impedance analysis device (Tanita®, Arlington Heights, IL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of a medical diagnosis of diabetes for at least 6 months
- HbA1c < 9%
- Age greater than 18 years
- Resident of Loma Linda, California area
Key exclusion criteria (4 listed)
- Allergy to peanuts
- Smokers
- History of irritable bowel disease or diverticulitis
- Statin therapy (unless stable statin dose for 3 months)
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 |
|---|---|---|
| Peanuts and peanut butterPeanuts and peanut butter | Dietary supplement | – |
Primary outcome
The primary outcome measure is HDL-C
Time frame: 12 weeks and 24 weeks
1 secondary outcome
Serum lipids, glucose, HbA1c, anthropometrics and blood pressure
Time frame: 12 weeks and 24 weeks
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 20 Jun 2012.
- Derived from this study: PubMed 24450471Wien M, Oda K, Sabate J. A randomized controlled trial to evaluate the effect of incorporating peanuts into an American Diabetes Association meal plan on the nutrient profile of the total diet and cardiometabolic parameters of adults with type 2 diabetes. Nutr J. 2014 Jan 22;13:10. doi: 10.1186/1475-2891-13-10.
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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.
Joan Sabaté, MD, DrPh principal investigator
Chair, Department of Nutrition
Michelle Wien, DrPH study director
Assistant Professor, Department of Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanuts and peanut butter in people with Type 2 Diabetes, run by Loma Linda University 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 4 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 20 Jun 2012. 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?
The primary outcome measure is HDL-C (time frame: 12 weeks and 24 weeks). 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 NCT00937222, which also lists 1 linked publication.
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 20 Jun 2012.