What's Hopping? Cricket Protein and Human Gut Microbiota

NCT03383341 | Completed

• 1 other identifier: 16-6966H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Edible insects are often considered a nutritious, protein-rich, environmentally sustainable alternative to traditional meat. They represent a new food for North American consumers. While the nutrient composition of several insects is characterized, all potential health impacts have not been evaluated. Crickets contain chitin and other fibers that may influence gut health. In this study, we evaluated the effects of consuming 25 grams/day whole cricket powder on gut microbiota composition, while assessing safety and tolerability. Twenty healthy adults participated in this six-week, double-blind, crossover dietary intervention. Participants were randomized into two treatment arms and consumed either cricket-containing or control breakfast foods for 14 days, followed by a 14-day washout period and assignment to the opposite arm. Blood and stool samples were collected at baseline and after each treatment period to assess liver function and microbiota changes. Results demonstrate that cricket consumption is tolerable and non-toxic at the treatment dose. Cricket powder supported growth of the probiotic bacteria, Bifidobacterium animalis, which increased more than 5.7-fold. Cricket consumption was also associated with reduced plasma TNF-a. These data suggest that eating crickets may improve gut health and reduce systemic inflammation; however, more research is needed to understand these effects and underlying mechanisms.

Conditions

Healthy

Keywords

gut microbiota; cricket powder; prebiotic fiber; inflammation; dietary intervention

Outcome Measures

Primary Outcomes (1)

• Change in gut microbiota with intervention foods

  Characterization of microbes in fecal samples using 16s sequencing methodologies.

  T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.

Secondary Outcomes (6)

• Change in liver function with intervention foods

  T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.

• Tolerability of intervention foods based on change in GI symptoms

  T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.

• Change in mucosal immunity with intervention foods

  T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.

• Change in microbial metabolism with intervention foods

  T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.

• Change in lipid metabolism with intervention foods

  T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.

Other Outcomes (1)

• Change in lipid absorption with intervention foods

  T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.

Study Arms (2)

Cricket powder protein

EXPERIMENTAL

Participants were provided with frozen 70 gram breakfast muffins and pre-mixed powder packets to prepare smoothies. Participants were asked to consume one muffin package and one smoothie (mixed with water or choice of milk/milk substitutes) daily for 14 days. The amount of intervention food consumed daily contained 25 grams of cricket protein powder.

Dietary Supplement: Cricket Protein Powder

Placebo Control

PLACEBO COMPARATOR

Participants were provided with a placebo comparator that included frozen 70 gram breakfast muffins and pre-mixed powder packets to prepare smoothies. Participants were asked to consume one muffin package and one smoothie (mixed with water or choice of milk/milk substitutes) daily for 14 days. These foods were formulated to taste and appear similar to the cricket intervention foods but did not consume any cricket powder.

Other: Placebo control

Interventions

Cricket Protein Powder DIETARY_SUPPLEMENT

Cricket powder was supplied by Entomo farms and consists of roasted and milled whole crickets.

Cricket powder protein

Placebo control OTHER

Placebo controls consisted of intervention foods (muffin and smoothie powder packet) that were visually and organoleptically similar to cricket-containing foods but contained no cricket powder.

Placebo Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy males and non-pregnant or lactating healthy females of any race or ethnicity and between the ages of 18-65 with a BMI between 18.5-29.9.

You may not qualify if:

• Individuals younger than 18 years of age or older than 65 years, and those outside of the BMI range of 18.5-29.9 will be excluded. Individuals will also be excluded if they have taken antibiotics or commercial probiotic/prebiotic supplements within two months of the start of the study treatment. Subjects who self-report food allergies will be excluded from the study because some proteins in insect foods are similar to those found in shellfish that could trigger an allergic reaction and tree nut or dairy products may be used in the breakfast foods.

Sponsors & Collaborators

• Colorado State University: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Location

Related Publications (1)

• Stull VJ, Finer E, Bergmans RS, Febvre HP, Longhurst C, Manter DK, Patz JA, Weir TL. Impact of Edible Cricket Consumption on Gut Microbiota in Healthy Adults, a Double-blind, Randomized Crossover Trial. Sci Rep. 2018 Jul 17;8(1):10762. doi: 10.1038/s41598-018-29032-2.

  PMID: 30018370 RESULT

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Recipes containing cricket powder were matched for taste, color, and texture to creat placebo intervention foods. All foods were prepared by study personnel and then blinded by a third party individual that was not directly associated with the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, placebo controlled crossover dietary intervention

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 26, 2017
• Study Start: February 1, 2017
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

US (1)