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

Overweight and Obesity Clinical Trial

— SNACKing  

Official title:

SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223323
• Other study ID #: 20154
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: University of Illinois at Urbana-Champaign
• Contact: Hannah D Holscher, PhD RD
• Phone: 217-300-2512
• Email: hholsche[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Almonds
Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.
• Pretzels
Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in markers of systemic inflammation & metabolism	Determine the impact of daily consumption of almonds on inflammation and metabolism compared to control (pretzels) by measuring biomarker concentrations with ELISA. Specifically, we will look at TNF, CRP, & LPS-BP (inflammatory) and NEFAs (metabolism).	Baseline & 12-week mark
Other	Changes in adiposity.	Determine the impact of daily consumption of almonds on adiposity compared to control (pretzels) using a DXA scan.	Baseline & 12-week mark
Other	Changes in subjective measures of gastrointestinal health.	Determine the impact of daily consumption of almonds on subjective measures of gut health compared to control (pretzels) using stool records. The questionnaire addresses questions related to gastrointestinal health including bloating, flatulence, and stool consistency.	Baseline & 12-week mark
Primary	Changes in gastrointestinal microbiota composition	Determine the impact of daily consumption of almonds on the gastrointestinal microbiota compared to control (pretzels) by sequencing the V4 region of the 16S rRNA gene in fecal samples.	Baseline & 12-week mark
Primary	Changes in abundance of fecal Roseburia spp	Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.	Baseline & 12-week mark
Primary	Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase	Determine the impact of daily consumption of almonds on the abundance of Butyryl CoA: Acetate CoA transferase gene compared to control (pretzels) by using quantitative real-time PCR.	Baseline & 12-week mark
Primary	Changes in gastrointestinal microbial-derived metabolite concentrations	Determine the impact of daily consumption of almonds on the concentration of microbial-derived metabolites compared to control (pretzels) by using gas-liquid chromatography. These metabolites include butyrate and secondary bile acids.	Baseline & 12-week mark
Secondary	Changes in liver fat	Determine the impact of daily consumption of almonds on liver fat percentages compared to control (pretzels) by quantitative liver ultrasound.	Baseline & 12-week mark
Secondary	Changes in glycemic control.	Determine the impact on oral glucose tolerance within intervention (almond) and control (pretzel) groups by using a mixed meal tolerance test.	Baseline & 12-week mark
Secondary	Changes in secondary measures of gastrointestinal health.	Determine the impact of daily consumption of almonds on gastrointestinal health compared to control (pretzels) by measuring fecal pH; other microbial fermentation end products and microbial-derived bile acids using gas-liquid chromatography; and alpha- and beta- diversity measures of the gut microbiota community structure using 16S microbiota analyses.	Baseline & 12-week mark