The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes

NCT01656850 | Completed Results DMC

• 1 other identifier: PV0805
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

hyperglycemia; hyperinsulinemia

Outcome Measures

Primary Outcomes (20)

• The Major Nutrients of NCEP Step 2 Diet and Almond Diets

  the entire study, up to 3 months

• Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention

  at the baseline and at the end of 3-month dietary intervention

• The Calories of NCEP Step 2 Diet and Almond Diets

  the entire study, up to 3 months

• Lipid Composition of NCEP Step 2 Diet and Almond Diets

  the entire study, up to 3 months

• Body Weight at the Baseline and at the End of 3-month Dietary Intervention

  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

  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

  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

  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

  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

  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

  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

  at the baseline and at the end of 3-month dietary intervention

• HOMA at the Baseline and the End of 3-month Dietary Intervention

  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

  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

  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

  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

  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

  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

  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

  at the baseline and at the end of 3-month dietary intervention

Study Arms (2)

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

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

Other: NCEP diet first, then Almond diet

Interventions

Almond diet first, then NCEP Diet OTHER

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

Almond diet first, then NCEP Diet

NCEP diet first, then Almond diet OTHER

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

NCEP diet first, then Almond diet

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 40-70 years,
• with BMI = 24-35 kg/m2,
• HbA1c 6.5-9 %, and
• regular use of oral hypoglycemic agents.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 28785295 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Hyperinsulinism

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Liu, Jen-Fang
• Organization: Taipei Medical University

liujenfa@mail.cgust.edu.tw

+886-3-2118999

Study Officials

• Jen-Fang Liu, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: August 3, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 16, 2016
• Results First Posted: February 11, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)