Almond Intervention in Type 2 Diabetes Mellitus

NCT ID: NCT02027740

Last Updated: 2014-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

almond

almonds are substituted for visible fat and carbohydrates

Group Type EXPERIMENTAL

almond

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

almond

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diabetes Foundation, India

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Anoop Misra

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fortis Flt Lt Hospital

Delhi, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

almond.2013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Almonds and Diabetes Management
NCT01161030 COMPLETED NA
Almond Butter and Fasting Glucose
NCT03826472 COMPLETED PHASE2
Multiple Grain in Type 2 Diabetes
NCT00337337 UNKNOWN PHASE4
Asian Indian Prediabetes Study
NCT04507685 COMPLETED NA