Topics

Berries, Inflammation, and Gut Microbiome

2019-09-27 06:30:45 | BioPortfolio

Summary

The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, and describe and link functional metagenomics and metatranscriptomic alterations in the gut microbiome with metabolite and inflammatory outcomes after acute (24hr) and chronic (4 week) intake of anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet (negative control), FOS (positive control, non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), or combination diet (berry composite + FOS) in human participants with low-grade inflammation.

Description

The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.

This is a single-center, randomized, single-blinded, 4-arm, placebo-controlled clinical trial. It features an acute single exposure 24-h protocol and a chronic 4-week daily intake protocol to evaluate the effects of anthocyanins and ellagitannins from strawberry and red raspberry intake compared to a control diet, FOS, or FOS and berries combined on gut inflammation, in adults with chronic low-grade inflammation.

A planned sample size of 88 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 5 study visits. This study will take 5 weeks per subject to complete.

The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through a high sensitivity C-Reactive Protein (hs-CRP) marker value, anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey related to general eating, health, mood and exercise habits.

Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit that involved blood/urine/fecal collection. Shopping lists and meal plans will be provided to subjects, along with counseling by the investigator's study investigators, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7-day wash-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 4 treatment sequences in the form of a drink: a mixed berries diet (raspberries and strawberries), a FOS diet (non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), a combination diet (mixed berries + FOS), or a control diet (negative control). Subjects will receive the same treatment for the duration of the study. Treatment codes will be maintained by the principal investigator.

Each visit will last ~2 hours and subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected at the 0 and 24h time points via a butterfly needle placed by a certified phlebotomist.

Study Design

Conditions

Overweight or Obesity

Intervention

Mixed berries, FOS, Control, Combination

Status

Not yet recruiting

Source

Institute for Food Safety and Health, United States

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-27T06:30:45-0400

Clinical Trials [2291 Associated Clinical Trials listed on BioPortfolio]

Goji Berries and Energy Expenditure

Effects of foods or food substances on energy expenditure are of particular interest, because of the increasing prevalence of obesity and its consequent metabolic diseases like type II dia...

Berry Components and Blood Sugar & Fat Metabolism

The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.

A FAMILY Program for Childhood Overweight and Obesity

Childhood overweight and obesity is a health problem with lifelong implications related to diabetes, hypertension, cardiovascular disease, psychological disorders as well as other chronic ...

Overweight and Obesity in Preschoolers

Obesity interventions in early childhood are recommended as they have been proven to be more effective than interventions later in life. The overall aim of this study is to assess the effe...

Evaluation of Non-drug and Drug Treatment of oVerweight and Obesity in pAtients of the Outpatient Register (EVA)

A prospective non-interventional single-centre study aimed to study the current practice of non-drug and drug treatment of overweight and obesity in patients with cardiovascular diseases o...

PubMed Articles [12625 Associated PubMed Articles listed on BioPortfolio]

Emotion and overeating behavior: effects of alexithymia and emotional regulation on overweight and obesity.

Obesity and overweight are significant risk factors for many serious diseases. Several studies have investigated the relationship between emotional regulation and overweight or obesity in people with ...

Youth overweight/obesity and its relationship with cardiovascular disease and parental risk factors.

The prevalence of overweight and obesity is gradually increasing in both developed and developing countries. Obesity, for instance, can present multifactorial causes that interact with each other. Amo...

DNA DAMAGE AND THEIR CONNECTION WITH EXCESSIVE BODY MASS AND OBESITY (REVIEW).

The aim of this article is to describe the current level of knowledge about the relationship between overweight and genomic instability. The relationship between overweight / obesity and cancer has be...

Association of frequency of television watching with overweight and obesity among women of reproductive age in India: Evidence from a nationally representative study.

For women of reproductive age, overweight and obesity are an established risk factor for several medical complications. To address the increasing rate of obesity in India through public health awarene...

The overweight and obesity transition from the wealthy to the poor in low- and middle-income countries: A survey of household data from 103 countries.

In high-income countries, obesity prevalence (body mass index greater than or equal to 30 kg/m2) is highest among the poor, while overweight (body mass index greater than or equal to 25 kg/m2) is prev...

Medical and Biotech [MESH] Definitions

A status with BODY WEIGHT that is above certain standard of acceptable or desirable weight. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal "over fat".

A condition of having excess fat in the abdomen. Abdominal obesity is typically defined as waist circumferences of 40 inches or more in men and 35 inches or more in women. Abdominal obesity raises the risk of developing disorders, such as diabetes, hypertension and METABOLIC SYNDROME X.

An integrated professional approach to screening, evaluation, control, and reduction of abnormal WEIGHT GAIN.

An indicator of body density as determined by the relationship of BODY WEIGHT to BODY HEIGHT. BMI=weight (kg)/height squared (m2). BMI correlates with body fat (ADIPOSE TISSUE). Their relationship varies with age and gender. For adults, BMI falls into these categories: below 18.5 (underweight); 18.5-24.9 (normal); 25.0-29.9 (overweight); 30.0 and above (obese). (National Center for Health Statistics, Centers for Disease Control and Prevention)

The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2.

More From BioPortfolio on "Berries, Inflammation, and Gut Microbiome"

Quick Search

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...


Searches Linking to this Trial