Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health

  • STATUS
    Recruiting
  • participants needed
    84
  • sponsor
    University of Illinois at Urbana-Champaign
Send
Updated on 16 February 2024
See if I qualify
microbiota

Summary

The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.

Description

This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.

Details
Condition Overweight and Obesity
Age 30years - 60years
Treatment Almonds, Pretzels
Clinical Study IdentifierNCT04223323
SponsorUniversity of Illinois at Urbana-Champaign
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Males & Females
-60 years of age
BMI 25-34.9 kg/m^2
Ability to drop off fecal sample within 15 minutes of defecation

Exclusion Criteria

Physician diagnosed metabolic or gastrointestinal diseases
Fasting blood glucose >126 mg/dL
Blood pressure >160/100 mm Hg
Anemia
Elevation in serum transaminases (i.e. >3 times the upper limit of normal)
Evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation
Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or medications known to impact bowel function
Pregnant, breastfeeding or postmenopausal
Smoker, tobacco use
Allergic to nuts
Consume > 2 alcoholic beverages/day
Abuse drugs
Have had > 5% weight change in the past month or > 10% change in the past year
Have taken antibiotics during the previous 2 months
Unable to consume the experimental treatments (almonds or pretzels)
Bariatric surgery
Gallbladder removal
Allergic to lidocaine or other topical anesthetics
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

microbiota

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.