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Completed

NCT Number: NCT02027740

Almond Intervention in Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fortis Flt Lt Hospital

Delhi, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

almond

Dietary Supplement

Primary outcomes

  1. Change in LDL-c

    Time frame: baseline, after six months

Secondary outcomes

  1. HbA1C

    Time frame: baseline, after six months of intervention

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jan 6, 2014
Registry last updated
Jan 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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