Almonds and Diabetes Management | NCT01161030

Studies
Almonds and Diabetes Management

NCT01161030

Sponsor

Arizona State University

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Almonds

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jul 9, 2010

First Submission Date that Met QC Criteria

Jul 12, 2010

First Posted Date

Jul 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses:

Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D The investigators were not able to demonstrate a relationship between GLP-1 secretion and almond consumption. Individuals with T2D were characterized with significantly greater GLP-1 secretion than the non-diabetic control subjects.
Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic responses in healthy controls and in individuals with T2D The investigators data support the hypothesis: almond consumption by individuals with T2D did attenuate postprandial glycemia; however, almond consumption did not alter glycemia in non-diabetic control subjects
Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c concentrations in individuals with T2D The investigators data demonstrated modest beneficial effect of almond consumption on A1c in individuals with T2D. Almond consumption was also associated with modest weight loss as compared to the control treatment (low fat cheese sticks).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
almonds	Experimental	1-oz raw almonds: 173 kcal, 4.6 g carbohydrate, 14.6 g fat	Dietary Supplement: Almonds
Control	Placebo Comparator	cheese stick	Dietary Supplement: Almonds

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Almonds	Dietary Supplement		Control almonds

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12 subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
24 subjects with diagnosed T2D for at least 1 year will be recruited for the chronic almond trial.
Subjects from the campus population and nearby communities will be recruited to participate in these trials.
Men and women must be willing to comply with the experimental protocol including the restriction of nut consumption:
- subjects recruited for the acute almond study must agree not to consume any nuts or nut butters for 1-week prior to and during the 2-week trial
- participants in the chronic almond study must agree not to consume nuts or nut butters more than 2 times per week during the 12 week trial.
Participants must have a body mass index (BMI) from 20 to 35 kg/m2 and are aged 30 to 70 years.
Subjects with T2D may take oral hyperglycemic agents.

Exclusion Criteria:

Insulin use
History of a peanut allergy
Chronic or unresolved disease
Current smoking habit
Pregnant or lactating
Medication use that may impact incretin secretion. [Incretins are gastrointestinal hormones secreted at meal-time.]

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases