Trial Outcomes & Findings for The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 Diabetes (NCT NCT01656850)

NCT ID: NCT01656850

Last Updated: 2016-11-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: the entire study, up to 3 months
• Results posted on: 2016-11-16

Participant Flow

Participant milestones

Measure	Whole Almonds First, Then NCEP Diet run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months)	NCEP Diet First, Then Whole Almonds Diet run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months)
First Intervention (3 Months) STARTED	20	20
First Intervention (3 Months) COMPLETED	17	16
First Intervention (3 Months) NOT COMPLETED	3	4
Washout (2 Weeks) STARTED	17	16
Washout (2 Weeks) COMPLETED	17	16
Washout (2 Weeks) NOT COMPLETED	0	0
Second Intervention (3 Months) STARTED	17	16
Second Intervention (3 Months) COMPLETED	17	16
Second Intervention (3 Months) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Whole Almonds First, Then NCEP Diet run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months)	NCEP Diet First, Then Whole Almonds Diet run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months)
First Intervention (3 Months) Withdrawal by Subject	3	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Almond Diet First, Then NCEP Diet n=17 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Diet First, Then Almond Diet n=16 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Gender Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Taiwan	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: the entire study, up to 3 months

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before before consuming almond diet	Alm After after consuming almond diet for 3 months
The Major Nutrients of NCEP Step 2 Diet and Almond Diets Crude protein	17.5 % of energy Standard Deviation 1.3	17.2 % of energy Standard Deviation 1.6	—	—
The Major Nutrients of NCEP Step 2 Diet and Almond Diets Fat	38.4 % of energy Standard Deviation 3.5	29.2 % of energy Standard Deviation 3.1	—	—
The Major Nutrients of NCEP Step 2 Diet and Almond Diets Carbohydrate	47.0 % of energy Standard Deviation 3.4	55.7 % of energy Standard Deviation 4.3	—	—

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention HDL	44.8 mg/dL Standard Deviation 12.9	49.7 mg/dL Standard Deviation 13.4	45.2 mg/dL Standard Deviation 11.9	48.5 mg/dL Standard Deviation 12.4
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention LDL	97.5 mg/dL Standard Deviation 29.3	102.9 mg/dL Standard Deviation 29.2	100.2 mg/dL Standard Deviation 29.5	98.0 mg/dL Standard Deviation 24.5
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention Total cholesterol	170.7 mg/dL Standard Deviation 31.9	180.6 mg/dL Standard Deviation 36.0	175.1 mg/dL Standard Deviation 36.0	178.9 mg/dL Standard Deviation 28.4
Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention Triglyceride	161.1 mg/dL Standard Deviation 83.7	141.2 mg/dL Standard Deviation 68.3	175.1 mg/dL Standard Deviation 36.0	178.9 mg/dL Standard Deviation 28.4

PRIMARY outcome

Timeframe: the entire study, up to 3 months

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before before consuming almond diet	Alm After after consuming almond diet for 3 months
The Calories of NCEP Step 2 Diet and Almond Diets	1,665.9 kcal Standard Deviation 153.8	1,643.4 kcal Standard Deviation 133.6	—	—

PRIMARY outcome

Timeframe: the entire study, up to 3 months

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before before consuming almond diet	Alm After after consuming almond diet for 3 months
Lipid Composition of NCEP Step 2 Diet and Almond Diets PUFA	22.0 g Standard Deviation 4.1	22.3 g Standard Deviation 4.5	—	—
Lipid Composition of NCEP Step 2 Diet and Almond Diets MUFA	30.7 g Standard Deviation 4.0	12.7 g Standard Deviation 3.3	—	—
Lipid Composition of NCEP Step 2 Diet and Almond Diets SFA	11.1 g Standard Deviation 3.3	9.5 g Standard Deviation 2.6	—	—

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Body Weight at the Baseline and at the End of 3-month Dietary Intervention	64.7 kg Standard Deviation 10.8	64.8 kg Standard Deviation 11.0	65.3 kg Standard Deviation 11.0	64.7 kg Standard Deviation 10.7

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention	31.6 percentage of body weight Standard Deviation 8.73	31.4 percentage of body weight Standard Deviation 9.40	31.0 percentage of body weight Standard Deviation 8.95	31.7 percentage of body weight Standard Deviation 8.63

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention SBP	124.2 mmHg Standard Deviation 15.2	123.6 mmHg Standard Deviation 18.2	124.5 mmHg Standard Deviation 14.0	122.1 mmHg Standard Deviation 13.4
Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention DBP	74.9 mmHg Standard Deviation 10.3	77.3 mmHg Standard Deviation 9.84	74.9 mmHg Standard Deviation 10.6	76.5 mmHg Standard Deviation 10.2

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention	146.5 mg/dL Standard Deviation 37.9	139.6 mg/dL Standard Deviation 33.1	140.7 mg/dL Standard Deviation 30.9	140.3 mg/dL Standard Deviation 36.8

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention	37424 mg.min/dL Standard Deviation 7681	36415 mg.min/dL Standard Deviation 7250	35768 mg.min/dL Standard Deviation 7379	37706 mg.min/dL Standard Deviation 8490

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention	11.2 mU/L Standard Deviation 4.9	12.3 mU/L Standard Deviation 6.0	10.4 mU/L Standard Deviation 4.6	11.8 mU/L Standard Deviation 5.7

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention	3975 mU.min/L Standard Deviation 2353	4690 mU.min/L Standard Deviation 3327	4055 mU.min/L Standard Deviation 2964	4345 mU.min/L Standard Deviation 2791

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention	7.47 percentage of hemoglubin Standard Deviation 1.12	7.45 percentage of hemoglubin Standard Deviation 0.80	7.51 percentage of hemoglubin Standard Deviation 0.97	7.39 percentage of hemoglubin Standard Deviation 1.05

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
HOMA at the Baseline and the End of 3-month Dietary Intervention	4.00 pg/mL Standard Deviation 2.08	4.24 pg/mL Standard Deviation 2.70	3.58 pg/mL Standard Deviation 1.75	3.98 pg/mL Standard Deviation 1.98

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention Apo A1	128.9 g/L Standard Deviation 23.9	135.1 g/L Standard Deviation 23.4	128.3 g/L Standard Deviation 22.8	135.3 g/L Standard Deviation 24.3
Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention Apo B	82.9 g/L Standard Deviation 22.2	85.8 g/L Standard Deviation 24.2	84.3 g/L Standard Deviation 23.3	86.7 g/L Standard Deviation 22.6

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention	59.6 μmol/L Standard Deviation 35.8	72.1 μmol/L Standard Deviation 55.3	62.5 μmol/L Standard Deviation 40.9	50.6 μmol/L Standard Deviation 26.7

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention sE-Selectin	43.4 ng/mL Standard Deviation 20.7	44.0 ng/mL Standard Deviation 20.2	46.1 ng/mL Standard Deviation 18.0	42.3 ng/mL Standard Deviation 15.5
Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention ICAM-1	22.3 ng/mL Standard Deviation 7.74	22.9 ng/mL Standard Deviation 7.22	24.0 ng/mL Standard Deviation 8.91	23.1 ng/mL Standard Deviation 8.09

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention	1.00 nmol/mg Standard Deviation 0.54	1.06 nmol/mg Standard Deviation 0.68	1.00 nmol/mg Standard Deviation 0.65	0.72 nmol/mg Standard Deviation 0.56

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention	32.8 U/L Standard Deviation 9.9	34.8 U/L Standard Deviation 10.9	33.9 U/L Standard Deviation 10.9	35.1 U/L Standard Deviation 9.9

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention	12.2 ng/mg creatinine Standard Deviation 6.19	14.2 ng/mg creatinine Standard Deviation 9.22	11.9 ng/mg creatinine Standard Deviation 4.24	12.2 ng/mg creatinine Standard Deviation 4.68

PRIMARY outcome

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

Outcome measures

Measure	Whole Almonds n=33 Participants whole almonds to replace 20% daily calorie intake whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake.	NCEP Step 2 Diet n=33 Participants follow NCEP step 2 diet NCEP Step 2 diet: follow NCEP step 2 diet	Alm Before n=33 Participants before consuming almond diet	Alm After n=33 Participants after consuming almond diet for 3 months
Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention	8.51 μmol/L Standard Deviation 3.37	9.24 μmol/L Standard Deviation 5.45	8.86 μmol/L Standard Deviation 4.43	9.57 μmol/L Standard Deviation 5.11

Adverse Events

Whole Almond Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NCEP Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Liu, Jen-Fang

Taipei Medical University

Phone: +886-3-2118999

Email: liujenfa@mail.cgust.edu.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place