Effects of Ultra Processed Food on Intestinal Energy Harvest

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorColumbia University

About this trial

Ultra processed food is everywhere in modern society and may contain multiple ingredients that affect the way participants' bodies store energy. Some studies have shown that eating a diet high in ultra processed foods leads to weight gain, but these foods have not been studied enough to understand why. Recently, the gut microbiome has become a potential way to measure energy balance in the human body; this is done by measuring how many calories are in the stool. The investigators propose to test a very high ultra-processed food diet where 80% of calories are coming from ultra processed food and a low ultra processed food diet where 20% of the calories are coming from ultra processed food. This study will compare stool sample energy content of the two diets.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI 30-40kg/m2

weight stable

able to download app and willing to use it for duration of study

does own grocery shopping

Disqualifiers

pregnancy

history of or planned bariatric surgery

history of anti obesity medications

Trial design

Design model

Crossover

Treatments tested in this trial

  • Diet containing 80% ultra processed foods

    Behavioral

    Very high ultra-processed food diet where 80% of calories are coming from ultra processed food

  • Diet containing 20% ultra processed foods

    Behavioral

    Low ultra processed food diet where 20% of the calories are coming from ultra processed food

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: 80% Ultra processedExperimental treatment 1 intervention
Group B: 20% Ultra processedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fecal energy loss

Amount of calories absorbed from diet will be the difference from energy intake - calories in stool

Time frame
2 weeks
2

Resting Energy Expenditure

Energy expenditure at rest, derived from whole-room calorimetry

Time frame
2 weeks
3

Body composition

Lean and fat mass quantified from QMR

Time frame
2 weeks

Secondary outcomes

1

Microbial taxa

Change in types of microbial taxa from baseline to end of diet period

Time frame
2 weeks

Other outcomes

1

Insulin, glucose, serum lipid and lipoproteins (mg/dl)

Bloods drawn at each timepoint will be assayed for overlapping metabolic markers

Time frame
2 weeks
2

C-peptide (ng/ml)

Bloods drawn at each timepoint will be assayed for overlapping metabolic markers

Time frame
2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

UNC Gillings School of Global Public Health

Collaborator