Almond Intervention in Type 2 Diabetes Mellitus

Cardiovascular Diseases Clinical Trial

Official title:

Effect of Almond Supplementation on Glycemic and Cardiovascular Risk Factors in Asian Indians in North India With Type 2 Diabetes Mellitus: A 24-week Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027740
• Other study ID #: almond.2013
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: January 3, 2014
• Start date: January 2009
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Diabetes Foundation, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This prospective cohort study of an almond-enriched diet (within the overall context of Asian Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM almond-enriched balanced diet improves glycemic measures and CVD risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients in the age range of 25-65 years

• on stable doses of metformin from past 3 months

• having HbA1C less than 9%

• LDL-c =100 mg/dl were recruited

Exclusion Criteria:

• Patients on insulin therapy, plioglitazone, insulin secretagogues, beta blockers or steroids or suffering from diabetes for more than 10 years

• having high uric acid levels (= 8 mg/dl),

• with accelerated hypertension (stage 2 hypertension according to JNC guidelines) , hypothyroidism, suffering from acute infection or any debilitating disease or with renal failure,

• appreciable weight loss (more than 10%) during past 6 months

• Patients with known food allergy, lipid altering medication or extraneous factors that can affect glycemic or lipid parameters

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• almond

Locations

Country	Name	City	State
India	Fortis Flt Lt Hospital	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Diabetes Foundation, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL-c		baseline, after six months	No
Secondary	HbA1C		baseline, after six months of intervention	No