NCT02027740

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

3.9 years

First QC Date

January 3, 2014

Last Update Submit

January 3, 2014

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in LDL-c

    baseline, after six months

Secondary Outcomes (1)

  • HbA1C

    baseline, after six months of intervention

Study Arms (1)

almond

EXPERIMENTAL

almonds are substituted for visible fat and carbohydrates

Dietary Supplement: almond

Interventions

almondDIETARY_SUPPLEMENT
almond

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortis Flt Lt Hospital

Delhi, India

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 6, 2014

Study Start

January 1, 2009

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

IN(1)