PrediabetesPhase 1NCT00270985
The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes
A Phase 1 study testing Nut free diet in people with Prediabetes and Insulin Resistance, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
Study Hypothesis: Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes. Lay Summary: Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Nut free diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2016
- Phase
- Phase 1
- 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
- Age greater than 18 years
- No self-reported allergy to almonds
- No history of irritable bowel disease or diverticulitis that could be exacerbated by daily almond intake
- Presence of pre-diabetes according to the 2005 American Diabetes Association diagnostic guidelines (fasting blood glucose between 100 to 125 mg/dl or casual blood glucose ≥ 140-199 mg/dl)
- Body mass index (BMI) 20-35 kg/m2 to enhance the generalizability of the study's findings to the population of adults with pre-diabetes
- Willingness to discontinue vitamin E supplement usage while enrolled in the study.
Who cannot join
- No concurrent use of corticosteroids or immunosuppressant medications (tacrolimus, cyclosporine, sirolimus, azathioprine, 6-mercaptopurine, mycophenolate mofetil, everolimus) in light of their effect on inflammatory biomarkers
- No liver disease, renal disease and/or severe dyslipidemia (triglycerides [TG] > 400mg/dl or total cholesterol [TC] > 300 mg/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Study Hypothesis:
Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes.
Read more
Lay Summary:
Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat, high-sugar diet can damage the blood vessels and increase the risk of strokes and heart attacks. A person's diet may produce substances in the blood that can interfere with the production of insulin in the pancreas. Sometimes, these changes in the insulin producing cells are serious and can eventually interfere with how the cells in the body use blood sugar, which causes T2DM. Techniques are available to measure circulating substances in the blood of persons with pre-diabetes that may be associated with the development of T2DM. Laboratory research has shown that almonds contain high levels of important compounds that may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily will be given to half of the study participants and the other participants will be given a meal plan that is "nut-free". Because of the potential to delay the onset of heart disease and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood samples for changes that may make the person with pre-diabetes more likely to develop heart disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds that may be influenced by consuming almonds daily. This study will also attempt to understand other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly those that might be related to body weight and body composition. Body composition techniques using very small amounts of electrical current are available to study body fat. Body weight, waist and hip measurements, blood pressure and body composition testing will be performed at the start of the study and every 4 weeks during the study. Lastly, these other possible causes of heart disease and T2DM will be investigated to look at relationships with the substances in the blood.
Read the detailed description
Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes.
Lay Summary:
Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat, high-sugar diet can damage the blood vessels and increase the risk of strokes and heart attacks. A person's diet may produce substances in the blood that can interfere with the production of insulin in the pancreas. Sometimes, these changes in the insulin producing cells are serious and can eventually interfere with how the cells in the body use blood sugar, which causes T2DM. Techniques are available to measure circulating substances in the blood of persons with pre-diabetes that may be associated with the development of T2DM. Laboratory research has shown that almonds contain high levels of important compounds that may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily will be given to half of the study participants and the other participants will be given a meal plan that is "nut-free". Because of the potential to delay the onset of heart disease and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood samples for changes that may make the person with pre-diabetes more likely to develop heart disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds that may be influenced by consuming almonds daily. This study will also attempt to understand other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly those that might be related to body weight and body composition. Body composition techniques using very small amounts of electrical current are available to study body fat. Body weight, waist and hip measurements, blood pressure and body composition testing will be performed at the start of the study and every 4 weeks during the study. Lastly, these other possible causes of heart disease and T2DM will be investigated to look at relationships with the substances in the blood.
- Conditions
- Prediabetes, Insulin Resistance, Metabolic Syndrome
- Being tested
- Almonds in a calorie controlled diet, Nut free diet
- Keywords
- almonds, pre-diabetes, inflammatory, CRP
- Medical subject headings
- Prediabetic State, Insulin Resistance, Metabolic Syndrome, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almonds in a calorie controlled dietBehavioural
Prescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes
Nut free dietBehavioural
Calorie controlled diet free of nuts for adults with pre-type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| nut free diet | Active comparator | ADA recommended diabetes diet without any nuts Receives: Behavioral: Nut free diet |
| almond group | Experimental | calorie controlled diet with prescribed daily amount of almonds Receives: Behavioral: Almonds in a calorie controlled diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
change in HbA1c over the course of 16 wk intervention as an indication of blood glucose control
Measured: 16 weeks
Secondary outcomes (2)
hs-CRP
change in high sensitivity C Reactive Protein as an indication of inflammation over course of the intervention
Measured: 16 wks
Il-6
Change in Interleukin 6 over the 16 week intervention as an indication of inflammation/metabolic syndrome
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2007
- Study completionJun 2016
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 PrediabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Susan E Gould Fogerite, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270985
- Sponsor's protocol ID
- 0120050322
- Status last verified
- Jun 2016
- First submitted
- 27 Dec 2005
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available.
Publications
Wien M, Bleich D, Raghuwanshi M, Gould-Forgerite S, Gomes J, Monahan-Couch L, Oda K. Almond consumption and cardiovascular risk factors in adults with prediabetes. J Am Coll Nutr. 2010 Jun;29(3):189-97. doi: 10.1080/07315724.2010.10719833.
PubMed 20833991
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes
- ClinicalTrials.gov ID
- NCT00270985
- Acronym / sponsor ID
- 0120050322
- Conditions
- Prediabetes, Insulin Resistance, Metabolic Syndrome
- Keywords
- almonds, pre-diabetes, inflammatory, CRP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Jan 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Dec 2005 (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.
Study Hypothesis:
Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes.
Lay Summary:
Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat, high-sugar diet can damage the blood vessels and increase the risk of strokes and heart attacks. A person's diet may produce substances in the blood that can interfere with the production of insulin in the pancreas. Sometimes, these changes in the insulin producing cells are serious and can eventually interfere with how the cells in the body use blood sugar, which causes T2DM. Techniques are available to measure circulating substances in the blood of persons with pre-diabetes that may be associated with the development of T2DM. Laboratory research has shown that almonds contain high levels of important compounds that may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily will be given to half of the study participants and the other participants will be given a meal plan that is "nut-free". Because of the potential to delay the onset of heart disease and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood samples for changes that may make the person with pre-diabetes more likely to develop heart disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds that may be influenced by consuming almonds daily. This study will also attempt to understand other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly those that might be related to body weight and body composition. Body composition techniques using very small amounts of electrical current are available to study body fat. Body weight, waist and hip measurements, blood pressure and body composition testing will be performed at the start of the study and every 4 weeks during the study. Lastly, these other possible causes of heart disease and T2DM will be investigated to look at relationships with the substances in the blood.
Detailed description
Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes.
Lay Summary:
Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat, high-sugar diet can damage the blood vessels and increase the risk of strokes and heart attacks. A person's diet may produce substances in the blood that can interfere with the production of insulin in the pancreas. Sometimes, these changes in the insulin producing cells are serious and can eventually interfere with how the cells in the body use blood sugar, which causes T2DM. Techniques are available to measure circulating substances in the blood of persons with pre-diabetes that may be associated with the development of T2DM. Laboratory research has shown that almonds contain high levels of important compounds that may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily will be given to half of the study participants and the other participants will be given a meal plan that is "nut-free". Because of the potential to delay the onset of heart disease and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood samples for changes that may make the person with pre-diabetes more likely to develop heart disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds that may be influenced by consuming almonds daily. This study will also attempt to understand other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly those that might be related to body weight and body composition. Body composition techniques using very small amounts of electrical current are available to study body fat. Body weight, waist and hip measurements, blood pressure and body composition testing will be performed at the start of the study and every 4 weeks during the study. Lastly, these other possible causes of heart disease and T2DM will be investigated to look at relationships with the substances in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nut free diet | Active comparator | Behavioral: Nut free dietADA recommended diabetes diet without any nuts |
| almond group | Experimental | Behavioral: Almonds in a calorie controlled dietcalorie controlled diet with prescribed daily amount of almonds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18 years
- No self-reported allergy to almonds
- No history of irritable bowel disease or diverticulitis that could be exacerbated by daily almond intake
- Presence of pre-diabetes according to the 2005 American Diabetes Association diagnostic guidelines (fasting blood glucose between 100 to 125 mg/dl or casual blood glucose ≥ 140-199 mg/dl)
- Body mass index (BMI) 20-35 kg/m2 to enhance the generalizability of the study's findings to the population of adults with pre-diabetes
Key exclusion criteria (2 listed)
- No concurrent use of corticosteroids or immunosuppressant medications (tacrolimus, cyclosporine, sirolimus, azathioprine, 6-mercaptopurine, mycophenolate mofetil, everolimus) in light of their effect on inflammatory biomarkers
- No liver disease, renal disease and/or severe dyslipidemia (triglycerides [TG] > 400mg/dl or total cholesterol [TC] > 300 mg/dl)
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 |
|---|---|---|
| Almonds in a calorie controlled dietPrescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes | Behavioural | almond group |
| Nut free dietCalorie controlled diet free of nuts for adults with pre-type 2 diabetes | Behavioural | nut free diet |
Primary outcome
HbA1c
Time frame: 16 weeks
change in HbA1c over the course of 16 wk intervention as an indication of blood glucose control
2 secondary outcomes
hs-CRP
Time frame: 16 wks
Il-6
Time frame: 16 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 22 Jun 2016.
- Results publication: PubMed 20833991Wien M, Bleich D, Raghuwanshi M, Gould-Forgerite S, Gomes J, Monahan-Couch L, Oda K. Almond consumption and cardiovascular risk factors in adults with prediabetes. J Am Coll Nutr. 2010 Jun;29(3):189-97. doi: 10.1080/07315724.2010.10719833.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available.
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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.
Susan E Gould Fogerite, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nut free diet in people with Prediabetes and Insulin Resistance, run by University of Medicine and Dentistry of New Jersey 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 6 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 22 Jun 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HbA1c (time frame: 16 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 NCT00270985, 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 22 Jun 2016.