Type 2 DiabetesNCT01656850
The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes
A study testing Almond diet first, then NCEP Diet and NCEP diet first, then Almond diet in people with Type 2 Diabetes, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of the study is to examine whether almond consumption for 3 month will help Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Almond diet first, then NCEP Diet and NCEP diet first, then Almond diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 40-70 years,
- with BMI = 24-35 kg/m2,
- HbA1c 6.5-9 %, and
- regular use of oral hypoglycemic agents.
Who cannot join
- Use of insulin to control blood glucose
- Regular use of oral steroids
- Regular use of anti-inflammatory agents (prescribed [Rx] or over-the-counter [OTC])
- Gain or loss of larger than 5% of body weight in the last 6 months
- CVD: coronary artery disease, left ventricular hypertrophy evidenced by echocardiogram, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease, dysautonomia
- Gastrointestinal: diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease, inflammatory bowel disease, treatment with acid-lowering drugs
Show all 17Show fewer
- Renal: chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis, diabetic nephropathy, serum creatinine > 1.5 mg/dL
- Endocrine: disease, untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease, hyperuricemia
- Rheumatologic: gout, inflammatory arthritis
- Active treatment for cancer of any type (except basal cell carcinoma) 1 year
- Systolic blood pressure larger than 150 mmHg, and diastolic blood pressure larger than 95 mmHg.
- Any history of or known allergies to nuts of any kind
- Frequent nut consumption, defined as ≥ 3 oz/wk; however, subjects who are willing to refrain from eating all nuts and nut products for 6 wk prior to their initial visit (Visit 1) may be considered eligible
- Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their initial visit (Visit 1) and throughout the entire study may be considered eligible
- Usual daily ethanol intake of larger or equal to 2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor)
- Illicit drug use
- Specific laboratory blood or urine analysis parameters of: creatinine larger than 1.5 mg/dL, ALT and AST larger than 1.5 nmol/L, and urinalysis - hematuria and proteinuria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Whole Almonds on Glucoregulation, Endothelial Function, Inflammation, Lipid Profile, and Oxidative Stress in Chinese Patients With Type 2 Diabetes
The purpose of the study is to examine whether almond consumption for 3 month will help Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of cardiovascular disease.
Read the detailed description
Our previous study demonstrated almonds (~60 g/d) improved lipid profile, glucoregulation, inflammation, and oxidative stress in 20 Chinese patients with type 2 diabetes mellitus (T2DM). To follow-up and expand this work with a more robust trial, the investigators propose a larger (n = 40), longer-term (90-d) investigation of the effect of almonds (~60 g/d) on adipokine regulation, endothelial function, glucoregulation, inflammation, lipid profile, and oxidative stress in Chinese patients with T2DM as compared to a placebo control. The investigators will conduct a 7-mo randomized, cross-over, placebo controlled clinical trial in which all meals will be provided to all subjects (n = 40). During the first 2 weeks (run-in period), all subjects will receive a control diet resembling a typical Taiwan diet, prepared based on the NCEP Step 2 guidelines. During the following 3 mo (Phase I), subjects will be randomized to receive either the control diet or the control diet with whole almonds (~60g/d) incorporated to replace 20% calories. After a 2-wk washout period during which all subjects will once again receive the control diet, subjects will receive the opposite diet to the one assigned during the Phase I for the other 3 months (Phase II). The caloric content of each diet will be adjusted to each subjects' energy needs to prevent any change in body weight. The following biomarkers will be determined at the baseline and end of each dietary intervention: Glucoregulation: fasted serum HbA1c, glucose and insulin, postprandial serum glucose and insulin, and urinary C-peptide; Endothelial Function: brachial artery FMD and serum nitric oxide, e-selectin, endothelial-1 (ET-1), and intracellular adhesion molecule-1 (ICAM-1); Adipokine Regulation: serum adiponectin, leptin, and resistin; Inflammation: serum high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-10, retinol binding protein-4 (RBP-4), and tumor necrosis factor (TNF)-α; Oxidative Stress: urinary isoprostanes (adjusted for creatinine) and serum protein carbonyls and oxidized LDL; and Lipid Profile: serum cholesterol, triglycerides, and apolipoproteins A1 and B.
- Conditions
- Type 2 Diabetes
- Being tested
- Almond diet first, then NCEP Diet, NCEP diet first, then Almond diet
- Keywords
- hyperglycemia, hyperinsulinemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond diet first, then NCEP DietOther
whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake. Subjects were assigned to receive almond diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to NCEP Diet for 12 weeks
NCEP diet first, then Almond dietOther
NCEP diet first, then Almond diet. Subjects were assigned to receive NCEP diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to almond diet for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Almond diet first, then NCEP Diet | Experimental | In a 28-wk randomized, cross-over, controlled feeding trial with a 2 week washout between alternative diets, subjects were assigned to receive NCEP or almond diet for 12 weeks after a 2-weeks run-in period Receives: Other: Almond diet first, then NCEP Diet |
| NCEP diet first, then Almond diet | Experimental | In a 28-wk randomized, cross-over, controlled feeding trial with a 2 week washout between alternative diets, subjects were assigned to receive NCEP or almond diet for 12 weeks after a 2-weeks run-in period Receives: Other: NCEP diet first, then Almond diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Major Nutrients of NCEP Step 2 Diet and Almond Diets
Measured: the entire study, up to 3 months
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
The Calories of NCEP Step 2 Diet and Almond Diets
Measured: the entire study, up to 3 months
Lipid Composition of NCEP Step 2 Diet and Almond Diets
Measured: the entire study, up to 3 months
Body Weight at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
HOMA at the Baseline and the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention
Measured: at the baseline and at the end of 3-month dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Taipei Medical 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jen-Fang Liu, Taipei Medical University
- Investigators
- Jen-Fang Liu, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656850
- Sponsor's protocol ID
- PV0805
- Status last verified
- Nov 2016
- First submitted
- 13 Jan 2012
- Last updated
- 16 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chen CM, Liu JF, Li SC, Huang CL, Hsirh AT, Weng SF, Chang ML, Li HT, Mohn E, Chen CO. Almonds ameliorate glycemic control in Chinese patients with better controlled type 2 diabetes: a randomized, crossover, controlled feeding trial. Nutr Metab (Lond). 2017 Aug 2;14:51. doi: 10.1186/s12986-017-0205-3. eCollection 2017.
PubMed 28785295
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Almonds on Glucoregulation, Endothelial Function, Inflammation, Lipid Profile, and Oxidative Stress in Chinese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01656850
- Acronym / sponsor ID
- PV0805
- Conditions
- Type 2 Diabetes
- Keywords
- hyperglycemia, hyperinsulinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Posted 11 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine whether almond consumption for 3 month will help Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of cardiovascular disease.
Detailed description
Our previous study demonstrated almonds (~60 g/d) improved lipid profile, glucoregulation, inflammation, and oxidative stress in 20 Chinese patients with type 2 diabetes mellitus (T2DM). To follow-up and expand this work with a more robust trial, the investigators propose a larger (n = 40), longer-term (90-d) investigation of the effect of almonds (~60 g/d) on adipokine regulation, endothelial function, glucoregulation, inflammation, lipid profile, and oxidative stress in Chinese patients with T2DM as compared to a placebo control. The investigators will conduct a 7-mo randomized, cross-over, placebo controlled clinical trial in which all meals will be provided to all subjects (n = 40). During the first 2 weeks (run-in period), all subjects will receive a control diet resembling a typical Taiwan diet, prepared based on the NCEP Step 2 guidelines. During the following 3 mo (Phase I), subjects will be randomized to receive either the control diet or the control diet with whole almonds (~60g/d) incorporated to replace 20% calories. After a 2-wk washout period during which all subjects will once again receive the control diet, subjects will receive the opposite diet to the one assigned during the Phase I for the other 3 months (Phase II). The caloric content of each diet will be adjusted to each subjects' energy needs to prevent any change in body weight. The following biomarkers will be determined at the baseline and end of each dietary intervention: Glucoregulation: fasted serum HbA1c, glucose and insulin, postprandial serum glucose and insulin, and urinary C-peptide; Endothelial Function: brachial artery FMD and serum nitric oxide, e-selectin, endothelial-1 (ET-1), and intracellular adhesion molecule-1 (ICAM-1); Adipokine Regulation: serum adiponectin, leptin, and resistin; Inflammation: serum high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-10, retinol binding protein-4 (RBP-4), and tumor necrosis factor (TNF)-α; Oxidative Stress: urinary isoprostanes (adjusted for creatinine) and serum protein carbonyls and oxidized LDL; and Lipid Profile: serum cholesterol, triglycerides, and apolipoproteins A1 and B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond diet first, then NCEP Diet | Experimental | Other: Almond diet first, then NCEP DietIn a 28-wk randomized, cross-over, controlled feeding trial with a 2 week washout between alternative diets, subjects were assigned to receive NCEP or almond diet for 12 weeks after a 2-weeks run-in period |
| NCEP diet first, then Almond diet | Experimental | Other: NCEP diet first, then Almond dietIn a 28-wk randomized, cross-over, controlled feeding trial with a 2 week washout between alternative diets, subjects were assigned to receive NCEP or almond diet for 12 weeks after a 2-weeks run-in period |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 40-70 years,
- with BMI = 24-35 kg/m2,
- HbA1c 6.5-9 %, and
- regular use of oral hypoglycemic agents.
Key exclusion criteria (17 listed)
- Use of insulin to control blood glucose
- Regular use of oral steroids
- Regular use of anti-inflammatory agents (prescribed [Rx] or over-the-counter [OTC])
- Gain or loss of larger than 5% of body weight in the last 6 months
- CVD: coronary artery disease, left ventricular hypertrophy evidenced by echocardiogram, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease, dysautonomia
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 |
|---|---|---|
| Almond diet first, then NCEP Dietwhole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake. Subjects were assigned to receive almond diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to NCEP Diet for 12 weeks | Other | Almond diet first, then NCEP Diet |
| NCEP diet first, then Almond dietNCEP diet first, then Almond diet. Subjects were assigned to receive NCEP diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to almond diet for 12 weeks | Other | NCEP diet first, then Almond diet |
Primary outcome
The Major Nutrients of NCEP Step 2 Diet and Almond Diets
Time frame: the entire study, up to 3 months
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
The Calories of NCEP Step 2 Diet and Almond Diets
Time frame: the entire study, up to 3 months
Lipid Composition of NCEP Step 2 Diet and Almond Diets
Time frame: the entire study, up to 3 months
Body Weight at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
HOMA at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention
Time frame: at the baseline and at the end of 3-month dietary intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28785295Chen CM, Liu JF, Li SC, Huang CL, Hsirh AT, Weng SF, Chang ML, Li HT, Mohn E, Chen CO. Almonds ameliorate glycemic control in Chinese patients with better controlled type 2 diabetes: a randomized, crossover, controlled feeding trial. Nutr Metab (Lond). 2017 Aug 2;14:51. doi: 10.1186/s12986-017-0205-3. eCollection 2017.
- 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.
Jen-Fang Liu, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond diet first, then NCEP Diet and NCEP diet first, then Almond diet in people with Type 2 Diabetes, run by Taipei Medical University at 1 site in Taiwan.
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 17 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 16 Nov 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Major Nutrients of NCEP Step 2 Diet and Almond Diets (time frame: the entire study, up to 3 months). The study lists 20 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 NCT01656850, 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 16 Nov 2016.