The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorÖrebro University, Sweden

About this trial

The aim of this crossover intervention study is to evaluate the volatile organic compounds (VOCs) present in participants at baseline and how these levels change after consuming either a low- or high-dietary fiber diet for three days. This study will involve adults, 18-65 years old, without any gastrointestinal diseases.

The primary objectives are to characterize baseline VOC profiles, assess changes in these profiles after a short-term dietary fiber intervention, determine if specific VOC patterns correlate with dietary fiber intake, and identify the time points at which VOC levels peak. This information will help establish the optimal timing for breath sampling and potentially provide insight into how VOC patterns relate to dietary fiber consumption and degradation.

The expected outcome is that a high-dietary fiber diet will produce a VOC profile enriched in metabolites associated with fiber fermentation compared to a low-dietary fiber diet, and that these VOCs will be consistent with those identified in vitro during fecal fermentation. Each participant will serve as an internal control, enabling within-subject comparisons of VOC levels at baseline and following the dietary fiber intervention.

Participants will receive a whole-food product that is rich in dietary fiber and will consume either a low-fiber diet (10 g/day) or a high-fiber diet (40 g/day) for three days. On the first day of each intervention, participants will also ingest a pH capsule to monitor gastrointestinal pH continuously throughout the three days. After a three-week washout period, participants will cross over to the other intervention arm and undergo another round of gastrointestinal pH monitoring.

In addition to the dietary intervention, participants will complete food and health questionnaires to assess habitual fiber intake and dietary habits. Fecal samples will be collected for in vitro fermentation to functionally profile the gut microbiota by assessing fecal VOCs, short-chain fatty acids (SCFA), and the microbial enzymatic activity and its pH-dependent modulation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signed informed consent obtained prior to any study-related procedures.

Willingness to refrain from regular consumption of prebiotic or probiotic products, as well as medications known to affect gastrointestinal function, for at least four weeks prior to the study visits.

Disqualifiers

History of complicated gastrointestinal surgery.

Presence of a gastrointestinal diagnosis or any condition that, in the opinion of the principal investigator, may influence the study outcomes.

Current diagnosis of a psychiatric disorder.

Systemic use of antibiotics or steroid medications within the past 3 months.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low, High Fiber Diet

    Other intervention

    Dietary Intervention: Low Fiber Diet Whole food dietary fiber product, 10g of dietary fiber consumed per day for 3 days Dietary Intervention: High Fiber Diet Whole food dietary fiber product, 40g of dietary fiber consumed per day for 3 days

  • High, Low Fiber Diet

    Other intervention

    Dietary Intervention: High Fiber Diet Whole food dietary fiber product, 40g of dietary fiber consumed per day for 3 days Dietary Intervention: Low Fiber Diet Whole food dietary fiber product, 10g of dietary fiber consumed per day for 3 days

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Low Fiber Diet, Then High Fiber DietExperimental treatment 1 intervention
Group B: High Fiber Diet, Then Low Fiber DietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effect of a 3-day low fiber diet compared to a 3-day high fiber diet on the Volatile Organic Compound profiles in exhaled breath

Volatile Organic Compound profiles in produced by the 3-day low fiber diet intervention compared to the profiles produced by the 3-day high fiber diet, with a 3-week washout inbetween

Time frame
5 weeks

Secondary outcomes

1

Effect of a low fiber diet on Volatile Organic Compound profiles after 4 hours

Volatile organic compound profiles 4 hours after the start of the low fiber diet intervention compared with baseline (0 hours)

Time frame
4 hours
2

Effect of a low fiber diet on Volatile Organic Compound profiles after 6 hours

Volatile organic compound profiles 6 hours after the start of the low fiber diet intervention compared with baseline (0 hours)

Time frame
6 hours
3

Effect of a low fiber diet on Volatile Organic Compound profiles after 8 hours

Volatile organic compound profiles 8 hours after the start of the low fiber diet intervention compared with baseline (0 hours)

Time frame
8 hours
4

Effect of a high fiber diet on Volatile Organic Compound profiles after 4 hours

Volatile organic compound profiles 4 hours after the start of the high fiber diet intervention compared with baseline (0 hours)

Time frame
4 hours

Other outcomes

1

Fecal Volatile Organic Compound profiles

Changes in fecal Volatile Organic Compound profiles produced during fecal fermentation, comparison of baseline (0 hours) profiles with profiles at 24 hours

Time frame
1 week
2

SCFA

Changes in SCFA levels produced during fecal fermentation, comparison of baseline (0 hours) levels with levels at 24 hours

Time frame
1 Week
3

Microbial enzymatic activity

Changes in microbial enzymatic activity during fecal fermentation, comparison of baseline (0 hours) activity with activity at 24 hours

Time frame
1 week
4

Microbiota composition

Microbiota composition at baseline (0 hours) compared with composition at 24 hours

Time frame
1 week

Sponsors and contacts

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Örebro University, Sweden

Lead sponsor

University of Helsinki

Collaborator

European Innovation Council

Collaborator