Almond Intervention in Type 2 Diabetes Mellitus

Diabetes Foundation, India

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: almond

Study type: Interventional

Funder types: Other

Identifiers

NCT02027740

almond.2013

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

almond

Experimental group

Description:

almonds are substituted for visible fat and carbohydrates

Treatment:

Dietary Supplement: almond