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Almond Butter and Fasting Glucose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826472
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Penny, Penn State University

Brief Summary:
A two-period randomized crossover study will be conducted to determine the effect of almond butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not taking insulin.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Other: Almond Butter Phase 2

Detailed Description:
Control of fasting blood glucose is a challenge for many individuals with diabetes. Researchers want to better understand how a nighttime snack can affect morning fasting blood glucose. A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 1 week. During the almond butter treatment, participants will consume 2 tbsp of almond butter per day as an evening snack. The control treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take simple cognitive tests on a study-provided smartphone each day of the study and report their daily food intake and physical activity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: CGM devices will be blinded.
Primary Purpose: Treatment
Official Title: Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes
Actual Study Start Date : March 8, 2019
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Almond Butter
Participants will consume one ounce per day (~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
Other: Almond Butter
Natural almond butter

No Intervention: No-snack Control
Participants will consume nothing besides water after dinner/bed sleep.



Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: 2 weeks ]
    Measured by continuous glucose monitoring (interstitial glucose)


Secondary Outcome Measures :
  1. Glucose trends [ Time Frame: 2 weeks ]
    Measured by continuous glucose monitoring (interstitial glucose)

  2. Inhibitory control [ Time Frame: 2 weeks ]
    Measured by smartphone-based cognitive task



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with diagnosed type 2 diabetes
  • Not on insulin therapy
  • On stable does of oral antihyperglycemic agent (no dose change for 6 months)
  • Currently monitoring blood glucose at home via glucometer
  • Willing and able to adhere to study protocol

Exclusion Criteria:

  • Individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver disease, cancer or inflammatory conditions (e.g. GI disorders, rheumatoid arthritis)
  • Women who are pregnant, breastfeeding, or have been pregnant within the last 6 months or breastfeeding within the last 6 weeks
  • Individuals who smoke or use tobacco products
  • Use of insulin therapy or sulfonylurea medications
  • Allergy to any tree nut
  • Liver or kidney disease
  • Allergy to Dexcom CGM adhesive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826472


Locations
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United States, Pennsylvania
Penn State
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Investigators
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Principal Investigator: Penny M Kris-Etherton, PhD, RDN Penn State
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Responsible Party: Penny, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT03826472    
Other Study ID Numbers: PKE AlmondButter
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases