## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** GFHNRC156
#### Organization
**Class:** FED
**Full Name:** USDA Grand Forks Human Nutrition Research Center
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-11

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-09

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-06-23

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2023-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-04
**Study First Submit QC Date:** 2023-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** USDA Grand Forks Human Nutrition Research Center

#### Responsible Party

**Investigator Affiliation:** USDA Grand Forks Human Nutrition Research Center

**Investigator Full Name:** Julie Hess

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Overweight

**Keywords:**

- Healthy Weight

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Beverage One (Milk)

**Label:** Beverage One (Milk)

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Beverage Two (Juice)

**Label:** Beverage Two (Juice)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Beverage One (Milk)

**Description:** Participant will consume beverage one (milk) and complete novel cognitive assessment questionnaire on paper.

**Name:** Beverage One (Milk)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Beverage Two (Juice)

**Description:** Participant will consume beverage two (fruit drink) and complete novel cognitive assessment questionnaire on paper.

**Name:** Beverage Two (Juice)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Written cognitive task results from novel cognitive assessment questionnaire.

**Time Frame:** 10 minutes post beverage ingestion

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** julie.hess@usda.gov

**Name:** Julie Hess, PhD

**Phone:** 701.795.8146

**Role:** CONTACT

**Contact 2:**

**Email:** madeline.comeau@usda.gov

**Name:** Madeline Comeau, MS

**Phone:** 701.795.8361

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Grand Forks

**Contacts:**

***Contact 1:***

- **Email:** angela.scheett@usda.gov

- **Name:** Angela J Scheett, MPH, RD

- **Phone:** 701-795-8386

- **Role:** CONTACT

**Country:** United States

**Facility:** USDA Grand Forks Human Nutrition Research Center

**State:** North Dakota

**Status:** RECRUITING

**Zip:** 58203

#### Overall Officials

**Official 1:**

**Affiliation:** USDA Grand Forks Human Nutrition Research Center

**Name:** Julie Hess, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Grand Forks Human Nutrition Research Center Current Nutrition Studies

**URL:** https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

### Misc Info Module

- Version Holder: 2024-05-24
