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

Sponsor
USDA Grand Forks Human Nutrition Research Center (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT05888779
Collaborator
(none)
160
1
2
12
13.3

Study Details

Study Description

Brief Summary

The objective of this study is to conduct novel research on the relationship between blood sugar and cognition.

Condition or Disease Intervention/Treatment Phase
  • Other: Beverage One (Milk)
  • Other: Beverage Two (Juice)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Beverage One (Milk)

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

Other: Beverage One (Milk)
Participant will consume beverage one (milk) and complete novel cognitive assessment questionnaire on paper.

Experimental: Beverage Two (Juice)

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

Other: Beverage Two (Juice)
Participant will consume beverage two (fruit drink) and complete novel cognitive assessment questionnaire on paper.

Outcome Measures

Primary Outcome Measures

  1. Written cognitive task results from novel cognitive assessment questionnaire. [10 minutes post beverage ingestion]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USDA Grand Forks Human Nutrition Research Center Grand Forks North Dakota United States 58203

Sponsors and Collaborators

  • USDA Grand Forks Human Nutrition Research Center

Investigators

  • Principal Investigator: Julie Hess, PhD, USDA Grand Forks Human Nutrition Research Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Julie Hess, Principal Investigator, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT05888779
Other Study ID Numbers:
  • GFHNRC156
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Julie Hess, Principal Investigator, USDA Grand Forks Human Nutrition Research Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023