NCT01787214

Brief Summary

Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may lead to a higher risk of developing heart disease. An important part of diabetes management involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat, protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM will participate in the study. Subjects will be randomized to consume an ADA diet with or without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar twice daily and wear a continuous glucose monitor during the three 72-hour study periods. Subjects will be between 40 and 70 years of age and will be recruited from the surrounding community using flyers and public service announcements. Consent will take place in the Department of Nutrition at Loma Linda University by the study investigators. In total, subject participation will last 5 weeks and all meals will be provided during the 3 study periods.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

February 1, 2013

Last Update Submit

March 17, 2014

Conditions

Type-2 Diabetes

Keywords

glucose variabilityglycemiatype-2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Within-day glucose variability

    The primary objective is to evaluate the effect of two isocaloric walnut-enriched meal plans versus a walnut-free ADA meal plan on within-day glucose variability in adults with diabetes by assessing: a) the overall standard deviation (SD) around the sensor glucose calculated for each day and then averaged over the 3-day study periods; b) the mean amplitude of glycemic excursions (MAGE) over the 3-day study periods.

    3 days

Secondary Outcomes (8)

  • Glucose variability dose response

    3 days

  • Dose response to between-day glycemic variability

    3 days

  • Glucose levels by meal

    3 days

  • Mean glucose of sensor range

    3 days

  • Duration of hypoglycemia

    3 days

  • +3 more secondary outcomes

Study Arms (3)

Full dose

ACTIVE COMPARATOR

full dose of walnuts (20% energy needs)

Dietary Supplement: Full dose

Half-dose

ACTIVE COMPARATOR

Half dose of walnuts (10% of energy needs)

Dietary Supplement: Half dose

Control

OTHER

Walnut free meals

Dietary Supplement: Control

Interventions

Full doseDIETARY_SUPPLEMENT

20% of daily energy needs supplied by walnuts

Full dose
Half doseDIETARY_SUPPLEMENT

10% of daily energy needs supplied by walnuts

Half-dose
ControlDIETARY_SUPPLEMENT

Walnut free meals

Control

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults between age 40 and 70 years with type 2 diabetes
  • duration of type 2 diabetes more than 6 months but less than 10 years
  • HbA1c 6.0-8.0%
  • BMI 25-40 kg/m2
  • diet controlled or stable dose of metformin for at least 3 months
  • willing to test blood glucose with personal meter twice a day during study test days

You may not qualify if:

  • using oral hypoglycemic agents or insulin
  • history of ischemic heart disease or congestive heart failure
  • history of severe diabetic complication (neuropathy, renal failure, stroke)
  • taking medication affecting glucose levels (i.e. corticosteroids)
  • active infectious disease
  • active malignancy
  • pregnant or breast feeding woman
  • smoker
  • history of daily caffeine or alcohol intake
  • known allergy to nuts
  • lactose or gluten intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University, Nichol Hall

Loma Linda, California, 92350, United States

Location

Study Officials

  • Michelle Wien, DrPH, RD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 8, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(1)