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

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Pretzels; Dietary Supplement: Almonds

Study type: Interventional

Funder types: Other

Identifiers

NCT04223323

20154

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

The intervention arm consists of daily consumption of the investigator's intervention snack over the course of 12 weeks.

Treatment:

Dietary Supplement: Almonds

Isocaloric Control

Placebo Comparator group

Description:

The control arm consists of daily consumption of an isocaloric snack over the course of 12 weeks.

Treatment:

Dietary Supplement: Pretzels