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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888779
• Other study ID #: GFHNRC156
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: Julie Hess, PhD
• Phone: 701.795.8146
• Email: julie.hess[@]usda.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes post beverage ingestion

External Links

•   Grand Forks Human Nutrition Research Center Current Nutrition Studies