## Protocol Section
### Identification Module
**NCT ID:** NCT01944579

**Brief Title:** Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

#### Organization Study ID Info
**ID:** HS40
#### Organization
**Class:** FED
**Full Name:** USDA Beltsville Human Nutrition Research Center
### Status Module
#### Completion Date
**Date:** 2014-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-07-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-07-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-04

**Type:** ACTUAL

#### Start Date
**Date:** 2013-09

**Status Verified Date:** 2014-07

#### Study First Post Date
**Date:** 2013-09-17
**Type:** ESTIMATED
**Study First Submit Date:** 2013-09-12
**Study First Submit QC Date:** 2013-09-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** FED

**Name:** Janet Novotny

#### Responsible Party

**Investigator Affiliation:** USDA Beltsville Human Nutrition Research Center

**Investigator Full Name:** Janet Novotny

**Investigator Title:** Research Physiologist

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role.

### Conditions Module

**Conditions:**

- Metabolic Syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

#### Enrollment Info

**Count:** 46

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries.

**Intervention Names:**

- Other: Blackberries

- Other: Control

**Label:** Control-Blackberry

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello).

**Intervention Names:**

- Other: Blackberries

- Other: Control

**Label:** Blackberry-Control

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Blackberry-Control

- Control-Blackberry

**Description:** Participants will receive blackberries as part of a controlled diet.

**Name:** Blackberries

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Blackberry-Control

- Control-Blackberry

**Description:** Participants will receive a control food (jello) as part of a controlled diet.

**Name:** Control

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Gene expression in whole blood will be evaluated at the beginning and end of each diet period, through global gene expression using the Affymetrix platform. Changes in specific genes observed with global gene expression technology will be confirmed through RT-PCR.

**Measure:** Change in gene expression

**Time Frame:** 0 weeks, 4 weeks

**Description:** Blood, urine, and feces will be analyzed by a technique called metabolomics, which is a broad sampling of metabolites.

**Measure:** Change in metabolomics

**Time Frame:** 0 weeks, 4 weeks

**Description:** Biomarkers of cancer risk such as oxidative stress and inflammatory markers will be analyzed at the beginning and end of each diet period.

**Measure:** Change in biomarkers of cancer

**Time Frame:** 0 weeks, 4 weeks

**Description:** Lipopolysaccharide will be measured in the blood as a measure of gut leakiness.

**Measure:** Change in lipopolysaccharide

**Time Frame:** 0 weeks, 4 weeks

#### Primary Outcomes

**Description:** Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.

**Measure:** Change in fecal microbiota

**Time Frame:** 0 weeks, 4 weeks

#### Secondary Outcomes

**Measure:** Change in blackberry nutrients & metabolites

**Time Frame:** 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 25-75 years old

Exclusion Criteria:

* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
* Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
* Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides greater than 300 mg/dL
* Fasting glucose greater than 126 mg/dL
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
* Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
* Use of any tobacco products in past 3 months
* Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
* Known (self-reported) allergy or adverse reaction to blackberries or other study foods
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beltsville

**Country:** United States

**Facility:** Beltsville Human Nutrition Research Center

**State:** Maryland

**Zip:** 20906

#### Overall Officials

**Official 1:**

**Affiliation:** USDA Beltsville Human Nutrition Research Center

**Name:** Janet A Novotny, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### 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: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Metabolic Syndrome

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000024821

- Term: Metabolic Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T75

- Name: Blackberry

- Relevance: HIGH

- As Found: TIGIT

### Misc Info Module

- Version Holder: 2024-05-24
