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Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition

Primary Purpose

Overweight

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beverage One (Milk)
Beverage Two (Juice)
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Healthy Weight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy weight to overweight (BMI 18.5-29.9 kg/m2) No food allergies or food intolerances Healthy (no chronic disease) as determined by online questionnaire Non-pregnant and non-lactating Not currently dieting or planning to follow a special diet Minimal restricted eating practices Exclusion Criteria: Obesity (BMI ≥ 30 kg/m2) Pregnant or lactating Currently dieting or planning to follow a special diet

Sites / Locations

  • USDA Grand Forks Human Nutrition Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Beverage One (Milk)

Beverage Two (Juice)

Arm Description

Participants will consume milk prior to completing a novel cognitive assessment on paper.

Participants will consume a fruit drink prior to completing a novel cognitive assessment on paper.

Outcomes

Primary Outcome Measures

Written cognitive task results from novel cognitive assessment questionnaire.
Results of cognitive task after consuming a study beverage (milk or fruit-flavored drink). More questions answered correctly results in a higher score. The assessment has a total of 10 questions, and participants will be asked to complete as much of this assessment as they can within a 5 minute timeframe.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
July 26, 2023
Sponsor
USDA Grand Forks Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05888779
Brief Title
Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition
Official Title
Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to conduct novel research on the relationship between blood sugar and cognition.
Detailed Description
This study is an acute parallel study design with one intervention visit needed per participant. There are 2 groups and 80 participants will be randomized into each group. Following the consent process, participants in each group will be seated individually in quiet rooms, with written instructions, several magazines, and a mini-fridge with beverages containing 110-120 kcals/8 fl oz. Participants will be provided instructions for the study, stating, "The study we are conducting explores the relationship between blood glucose and cognitive abilities. After consuming food or drink, your body regulates your blood glucose. Physical exertion can also affect blood glucose. Therefore, we ask that you relax in this space for 10-15 minutes. You can read the provided magazines during this time. Drinking a beverage will bring your body's blood glucose into the right phase for our questionnaires. In the fridge are some beverages, and we ask that you drink something." After 10-15 minutes, participants will be given a cognitive test (a questionnaire on paper) and asked to complete as much of it as they can within 5 minutes. Then, moving to a separate area, weight and height measurements will be taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Healthy Weight

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beverage One (Milk)
Arm Type
Experimental
Arm Description
Participants will consume milk prior to completing a novel cognitive assessment on paper.
Arm Title
Beverage Two (Juice)
Arm Type
Experimental
Arm Description
Participants will consume a fruit drink prior to completing a novel cognitive assessment on paper.
Intervention Type
Other
Intervention Name(s)
Beverage One (Milk)
Intervention Description
Participant will consume beverage one (milk) and complete novel cognitive assessment questionnaire on paper.
Intervention Type
Other
Intervention Name(s)
Beverage Two (Juice)
Intervention Description
Participant will consume beverage two (fruit drink) and complete novel cognitive assessment questionnaire on paper.
Primary Outcome Measure Information:
Title
Written cognitive task results from novel cognitive assessment questionnaire.
Description
Results of cognitive task after consuming a study beverage (milk or fruit-flavored drink). More questions answered correctly results in a higher score. The assessment has a total of 10 questions, and participants will be asked to complete as much of this assessment as they can within a 5 minute timeframe.
Time Frame
10 minutes post beverage ingestion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy weight to overweight (BMI 18.5-29.9 kg/m2) No food allergies or food intolerances Healthy (no chronic disease) as determined by online questionnaire Non-pregnant and non-lactating Not currently dieting or planning to follow a special diet Minimal restricted eating practices Exclusion Criteria: Obesity (BMI ≥ 30 kg/m2) Pregnant or lactating Currently dieting or planning to follow a special diet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Hess, PhD
Phone
701.795.8146
Email
julie.hess@usda.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Madeline Comeau, MS
Phone
701.795.8361
Email
madeline.comeau@usda.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Hess, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela J Scheett, MPH, RD
Phone
701-795-8386
Email
angela.scheett@usda.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
Grand Forks Human Nutrition Research Center Current Nutrition Studies

Learn more about this trial

Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition

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