Clinical trial NCT04223323: Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health
Official title: SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Almond
Gastrointestinal microbiota
Metabolic health
Bile acid profiles
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2020-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Males \& Females
* 30-60 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

Primary outcomes:
measure: Changes in gastrointestinal microbiota composition
timeFrame: Baseline & 12-week mark
measure: Changes in abundance of fecal Roseburia spp
timeFrame: Baseline & 12-week mark
measure: Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase
timeFrame: Baseline & 12-week mark
measure: Changes in gastrointestinal microbial-derived metabolite concentrations
timeFrame: Baseline & 12-week mark
Secondary outcomes:
measure: Changes in liver fat
timeFrame: Baseline & 12-week mark
measure: Changes in glycemic control.
timeFrame: Baseline & 12-week mark
measure: Changes in secondary measures of gastrointestinal health.
timeFrame: Baseline & 12-week mark
Other outcomes:
measure: Changes in markers of systemic inflammation & metabolism
timeFrame: Baseline & 12-week mark
measure: Changes in adiposity.
timeFrame: Baseline & 12-week mark
measure: Changes in subjective measures of gastrointestinal health.
timeFrame: Baseline & 12-week mark
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Hannah D Holscher, PhD RD
role: PRINCIPAL_INVESTIGATOR
References: