Insulin SensitivityNCT05358171

Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis

A study of Insulin Sensitivity and 24-hour Glucose Control, run by Virginia Polytechnic Institute and State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Insulin Sensitivity, 24-hour Glucose Control
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 15 Mar 2023to 30 Sep 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Weight stable for previous 6 months
Sedentary to recreationally active
No plans to gain/lose weight or change physical activity level
Willing to pick up food daily and consume foods provided for an 8-week period
Verbal and written informed consent
Approval by Medical Director
Estrogen or testosterone usage is acceptable, if on stable dose for >6 months

Who cannot join

BMI >35 kg/m2
Diabetes or diabetes medication
Antibiotic, prebiotic or prebiotic use in prior 3 months
TCHOL >6.2 mmol/L; TG >4.5 mmol/L
Blood pressure (BP) > 159/99 mmHg (Stable BP on antihypertensive medications used for >6 months is acceptable)
Diagnosed inflammatory bowel disease

Show all 11Show fewer

Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
Vegetarian or vegan
Pregnant or plans to become pregnant
Food allergies or aversions
3 or fewer stools per week or regular laxative use

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Tech
Blacksburg, Virginia, 24061

Other trials in United States

About this study

Official title: Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis in Mid-life Adults

Advancing age is associated with gut dysbiosis, low-grade chronic inflammation, progressive insulin resistance, and increased risk of type 2 diabetes (T2D). Prediabetes is present in 45-50% of middle-aged/older adults, and declines in glucose tolerance are evident in the third or fourth decade of life. Thus, there is an urgent need to identify new approaches for the prevention of type 2 diabetes among middle-aged adults. Observational research has linked intake of ultra-processed foods (UPF), which comprise ~60% of total energy intake in US adults, with increased risk of T2D. Ex vivo and animal research suggests that components of UPF alter gut microbiota composition and initiate a cascade of events leading to intestinal inflammation and impaired glycemic control. Whether mid-life adults (aged 45-65 yrs) are susceptible to the adverse impact of UPF consumption on glucose homeostasis is unknown. The overall objective of this study is to establish proof-of-concept for an impairment in glucose homeostasis following increases in UPF consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future. In addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which UPF consumption influences glucose homeostasis will be investigated.

Conditions: Insulin Sensitivity, 24-hour Glucose Control
Being tested: HIgh UPF controlled diet, No UPF controlled diet
Medical subject headings: Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIgh UPF controlled dietOther
Following a two- week eucaloric lead-in diet, participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, pre- and probiotics, and overall diet quality, for 6 weeks.
No UPF controlled dietOther
Following a two- week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, pre- and probiotics, and overall diet quality, for 6 weeks.

Study groups in NCT05358171
Study group	Role	What they receive
HIgh UPF (Ultra-processed foods)	Experimental	Participants will consume a diet containing 81% total energy from UPF for 6 weeks Receives: Other: HIgh UPF controlled diet
No UPF	Active comparator	Participants will consume a diet containing 0% total energy from UPF for 6 weeks Receives: Other: No UPF controlled diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in insulin sensitivity from baseline to 6-weeks post high or no UPF diet
Insulin sensitivity assessed using a 2-hour oral glucose tolerance test (75g glucose load). Blood will be collected at baseline (fasting), and thereafter at 30-minute intervals (5 total measurements in 2 hours) at baseline and post 6-weeks high or no UPF diet.
Measured: 2 timepoints (standardized diet lead-in [baseline]), 6-weeks post high or no UPF diet, 2-hour test in laboratory

Secondary outcomes (11)

Change in 24-hour glucose control (24-hour mean) from baseline to 6-weeks post high or no UPF diet
24-hour glucose control (24-hour mean glucose concentration) will be assessed using continuous glucose monitoring for a 6-day period at baseline and post high or no UPF diet.
Measured: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (AUC) from baseline to 6-weeks post high or no UPF diet
24-hour glucose control (24-hour AUC) will be assessed using continuous glucose monitoring for a 6-day period at baseline and post high or no UPF diet.
Measured: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (time in range) from baseline to 6-weeks post high or no UPF diet
24-hour glucose control (time in range) will be assessed using continuous glucose monitoring for a 6-day period at baseline and post high or no UPF diet.
Measured: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (glycemic variability [GV]) from baseline to 6-weeks post high or no UPF diet
24-hour glucose control (GV) will be assessed using continuous glucose monitoring for a 6-day period at baseline and post high or no UPF diet.
Measured: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (postprandial glucose) from baseline to 6-weeks post high or no UPF diet
Free-living postprandial glucose concentration will be assessed using continuous glucose monitoring for a 6-day period at baseline and post high or no UPF diet.
Measured: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in inflammatory cytokines from baseline to post 6-weeks high or no UPF diet
Inflammatory Cytokines, including TNF alpha, IL-6, and MCP-1 will be measured by ELISA (American Diagnostica Inc).
Measured: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in endotoxin from baseline to post 6-weeks high or no UPF diet
Serum endotoxin will be assessed using the PyroGene Recombinant Factor C endotoxin assay (Lonza, Basel, Switzerland).
Measured: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in gut microbial composition from baseline to post 6-weeks high or no UPF diet
Stool samples will be collected daily for 3 days before and during the final 3 days of the diet interventions. Samples will be collected daily and placed in sterile plastic containers, stored in personal freezers, and placed in coolers for transport then immediately frozen at -80°C until final processing and analysis.
Measured: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in gut microbial function from baseline to post 6-weeks high or no UPF diet
Stool samples will be collected daily for 3 days before and during the final 3 days of the diet interventions. Samples will be collected daily and placed in sterile plastic containers, stored in personal freezers, and placed in coolers for transport then immediately frozen at -80°C until final processing and analysis.
Measured: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in intestinal inflammation from baseline to post 6-weeks high or no UPF diet
Intestinal inflammation will be assessed using fecal calprotectin, lactoferrin, and lipocalin-2, measured using ELISA.
Measured: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in intestinal permeability from baseline to post 6-weeks high or no UPF diet
Intestinal permeability will be assessed using serum zonulin (Immunodiagnostik AG, Bensheim, Germany) concentrations, measured using ELISA.
Measured: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202330 Sep 2025

First posted3 May 2022
Study start15 Mar 2023
Primary completion30 Sep 2025
Study completion30 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Insulin SensitivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05358171
Sponsor's protocol ID: 21-974
Status last verified: Dec 2025
First submitted: 22 Apr 2022
Last updated: 14 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Capra BT, Hudson S, Helder M, Laskaridou E, Johnson AL, Gilmore C, Marinik E, Hedrick VE, Savla J, David LA, Davy KP, Davy BM. Ultra-processed food intake, gut microbiome, and glucose homeostasis in mid-life adults: Background, design, and methods of a controlled feeding trial. Contemp Clin Trials. 2024 Feb;137:107427. doi: 10.1016/j.cct.2024.107427. Epub 2024 Jan 4.
PubMed 38184104
Capra BT, Hudson S, Phillips KM, Marinik EL, Laskaridou E, Johnson AL, Wilson EA, Dong M, David LA, Ives N, Troob J, Zeng J, Savla JT, Hedrick VE, Davy KP, Davy BM. Chemical Analysis of Controlled Diets High in and Free of Ultraprocessed Foods and Proof-of-Concept Findings: Reducing Ultraprocessed Food Consumption May Lower Diabetes Risk in Midlife Adults. J Nutr. 2026 Mar;156(3):101370. doi: 10.1016/j.tjnut.2026.101370. Epub 2026 Jan 22.
PubMed 41577034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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All Insulin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis in Mid-life Adults
ClinicalTrials.gov ID: NCT05358171
Acronym / sponsor ID: 21-974
Conditions: Insulin Sensitivity, 24-hour Glucose Control
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
Collaborators: Duke University
Study start: 15 Mar 2023 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: 30 Sep 2025 (actual)
First posted: 3 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HIgh UPF (Ultra-processed foods)	Experimental	Other: HIgh UPF controlled dietParticipants will consume a diet containing 81% total energy from UPF for 6 weeks
No UPF	Active comparator	Other: No UPF controlled dietParticipants will consume a diet containing 0% total energy from UPF for 6 weeks

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Weight stable for previous 6 months
Sedentary to recreationally active
No plans to gain/lose weight or change physical activity level
Willing to pick up food daily and consume foods provided for an 8-week period
Verbal and written informed consent

Key exclusion criteria (11 listed)

BMI >35 kg/m2
Diabetes or diabetes medication
Antibiotic, prebiotic or prebiotic use in prior 3 months
TCHOL >6.2 mmol/L; TG >4.5 mmol/L
Blood pressure (BP) > 159/99 mmHg (Stable BP on antihypertensive medications used for >6 months is acceptable)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HIgh UPF controlled dietFollowing a two- week eucaloric lead-in diet, participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, pre- and probiotics, and overall diet quality, for 6 weeks.	Other	HIgh UPF (Ultra-processed foods)
No UPF controlled dietFollowing a two- week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, pre- and probiotics, and overall diet quality, for 6 weeks.	Other	No UPF

Primary outcome

Change in insulin sensitivity from baseline to 6-weeks post high or no UPF diet
Time frame: 2 timepoints (standardized diet lead-in [baseline]), 6-weeks post high or no UPF diet, 2-hour test in laboratory
Insulin sensitivity assessed using a 2-hour oral glucose tolerance test (75g glucose load). Blood will be collected at baseline (fasting), and thereafter at 30-minute intervals (5 total measurements in 2 hours) at baseline and post 6-weeks high or no UPF diet.

11 secondary outcomes

Change in 24-hour glucose control (24-hour mean) from baseline to 6-weeks post high or no UPF diet
Time frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (AUC) from baseline to 6-weeks post high or no UPF diet
Time frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (time in range) from baseline to 6-weeks post high or no UPF diet
Time frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (glycemic variability [GV]) from baseline to 6-weeks post high or no UPF diet
Time frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in 24-hour glucose control (postprandial glucose) from baseline to 6-weeks post high or no UPF diet
Time frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in inflammatory cytokines from baseline to post 6-weeks high or no UPF diet
Time frame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in endotoxin from baseline to post 6-weeks high or no UPF diet
Time frame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in gut microbial composition from baseline to post 6-weeks high or no UPF diet
Time frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in gut microbial function from baseline to post 6-weeks high or no UPF diet
Time frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in intestinal inflammation from baseline to post 6-weeks high or no UPF diet
Time frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Change in intestinal permeability from baseline to post 6-weeks high or no UPF diet
Time frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Background: PubMed 38184104Capra BT, Hudson S, Helder M, Laskaridou E, Johnson AL, Gilmore C, Marinik E, Hedrick VE, Savla J, David LA, Davy KP, Davy BM. Ultra-processed food intake, gut microbiome, and glucose homeostasis in mid-life adults: Background, design, and methods of a controlled feeding trial. Contemp Clin Trials. 2024 Feb;137:107427. doi: 10.1016/j.cct.2024.107427. Epub 2024 Jan 4.
Derived from this study: PubMed 41577034Capra BT, Hudson S, Phillips KM, Marinik EL, Laskaridou E, Johnson AL, Wilson EA, Dong M, David LA, Ives N, Troob J, Zeng J, Savla JT, Hedrick VE, Davy KP, Davy BM. Chemical Analysis of Controlled Diets High in and Free of Ultraprocessed Foods and Proof-of-Concept Findings: Reducing Ultraprocessed Food Consumption May Lower Diabetes Risk in Midlife Adults. J Nutr. 2026 Mar;156(3):101370. doi: 10.1016/j.tjnut.2026.101370. Epub 2026 Jan 22.
Individual participant dataSharing planned: No

Related trials for Insulin Sensitivity

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brenda Davy, PhD RDN principal investigator

Virginia Polytechnic Institute and State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Insulin Sensitivity and 24-hour Glucose Control, run by Virginia Polytechnic Institute and State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in insulin sensitivity from baseline to 6-weeks post high or no UPF diet (time frame: 2 timepoints (standardized diet lead-in [baseline]), 6-weeks post high or no UPF diet, 2-hour test in laboratory). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05358171, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.