ObesityNCT03341052
Characterization of Bile Acid Pathway in Obesity
A study testing Normal Diet, High Fat Diet and Low Fat Diet in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
It is unknown whether the bile acid pathway is altered in obesity. This study is designed to compare obesity and health to determine if the bile acid pathway differs depending on health state. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Normal Diet, High Fat Diet and Low Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 9 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Normal Weight Inclusion Criteria:
- Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
- BMI: 18.5-25 kg/m2
Obese Inclusion Criteria:
- Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
- BMI: ≥ 30 kg/m2
Exclusion Criteria for both Normal Weight and Obese Participants:
- History of abdominal surgery including cholecystectomy and other than appendectomy, Caesarian section or tubal ligation.
- Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, phentermine.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), a self-administered alcoholism screening test (AUDIT-C) and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HAD score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The AUDIT-C is a 3-item alcohol screening questionnaire that reliably identifies participants who are hazardous alcohol drinkers or have active alcohol use disorders. In men, a score of 4 or more is above the recommended limits will be reviewed by study personnel. In women, a score of 3 or more is above the recommended limits will be reviewed by study personnel. However when the points are above recommended limits, the provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility..
- Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, and thyroxin replacement therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
It is unknown whether the bile acid pathway is altered in obesity. This study is designed to compare obesity and health to determine if the bile acid pathway differs depending on health state.
Read the detailed description
This is a single center study involving diet intervention, including healthy obese and healthy normal weight participants. Participants will maintain their normal diet for 1 week, eat a high fat and high calorie diet for 1 week, return to their normal diet for 1 week, and eat a low fat and low calorie diet for 1 week, to study the effect of diet on the bile acid pathway in normal weight and obesity. During their first normal diet week, the high calorie week, and the low calorie week, blood samples will be collected at defined times to measure cholesterol, glycemia, Fibroblast Growth Factor 19 (FGF-19), Bile Acid (BA), C4, and incretins (GLP-1 (glucagon-like peptide-1), peptide tyrosine tyrosine (PYY 3-36)) fasting levels and responses to the meal. Stool samples will be collected for 48 hour BA excretion.
- Conditions
- Obesity
- Being tested
- Normal Diet, High Fat Diet, Low Fat Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal DietOther
The normal diet will consist of the participants' normal eating habits, and will be tracked by a food log. The participants will be on their normal diet during week 1 and week 3.
High Fat DietOther
The high fat diet will consist of 2700 kcal, 100g total fat (33%), 300mg cholesterol, 350g carbohydrates (52%), and 100g protein (15%). The participants will be on this diet during week 2.
Low Fat DietOther
The low fat diet will consist of 1200 kcal, 26g fat (20%), 78mg cholesterol, 150g carbohydrates (50%), and 100g protein (30%). The participants will be on this diet during week 4.
| Study group | Role | What they receive |
|---|---|---|
| Obese Participants | Active comparator | Participants will be on each diet for one week prior to collection of laboratory samples. Participants will be on their normal diet on weeks 1 and 3, on the high fat diet on week 2, and low fat diet on week 4. Receives: Other: Normal Diet; Other: High Fat Diet; Other: Low Fat Diet |
| Normal Weight Participants | Active comparator | Participants will be on each diet for one week prior to collection of laboratory samples. Participants will be on their normal diet on weeks 1 and 3, on the high fat diet on week 2, and low fat diet on week 4. Receives: Other: Normal Diet; Other: High Fat Diet; Other: Low Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and High Fat Diet
Change in 48h-fecal bile acid excretion (μmol/L) between baseline and high fat diet
Measured: Baseline to approximately day 7 of week 2
Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and Low Fat Diet
Change in 48h-fecal bile acid excretion (μmol/L) between baseline and low fat diet
Measured: Baseline to approximately day 7 of week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start14 Nov 2017
- Primary completion9 Oct 2021
- Study completion9 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres J. Acosta, M.D., Ph.D., Mayo Clinic
- Investigators
- Andres J Acosta Cardenas, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341052
- Sponsor's protocol ID
- 16-007060
- Other IDs
- K23DK114460
- Status last verified
- Apr 2023
- First submitted
- 1 Aug 2017
- Last updated
- 27 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Bile Acid Pathway in Obesity
- ClinicalTrials.gov ID
- NCT03341052
- Acronym / sponsor ID
- 16-007060
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 9 Oct 2021 (actual)
- Study completion
- 9 Oct 2021 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 27 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is unknown whether the bile acid pathway is altered in obesity. This study is designed to compare obesity and health to determine if the bile acid pathway differs depending on health state.
Detailed description
This is a single center study involving diet intervention, including healthy obese and healthy normal weight participants. Participants will maintain their normal diet for 1 week, eat a high fat and high calorie diet for 1 week, return to their normal diet for 1 week, and eat a low fat and low calorie diet for 1 week, to study the effect of diet on the bile acid pathway in normal weight and obesity. During their first normal diet week, the high calorie week, and the low calorie week, blood samples will be collected at defined times to measure cholesterol, glycemia, Fibroblast Growth Factor 19 (FGF-19), Bile Acid (BA), C4, and incretins (GLP-1 (glucagon-like peptide-1), peptide tyrosine tyrosine (PYY 3-36)) fasting levels and responses to the meal. Stool samples will be collected for 48 hour BA excretion.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese Participants | Active comparator | Other: Normal Diet, Other: High Fat Diet, Other: Low Fat DietParticipants will be on each diet for one week prior to collection of laboratory samples. Participants will be on their normal diet on weeks 1 and 3, on the high fat diet on week 2, and low fat diet on week 4. |
| Normal Weight Participants | Active comparator | Other: Normal Diet, Other: High Fat Diet, Other: Low Fat DietParticipants will be on each diet for one week prior to collection of laboratory samples. Participants will be on their normal diet on weeks 1 and 3, on the high fat diet on week 2, and low fat diet on week 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Normal DietThe normal diet will consist of the participants' normal eating habits, and will be tracked by a food log. The participants will be on their normal diet during week 1 and week 3. | Other | Normal Weight Participants, Obese Participants |
| High Fat DietThe high fat diet will consist of 2700 kcal, 100g total fat (33%), 300mg cholesterol, 350g carbohydrates (52%), and 100g protein (15%). The participants will be on this diet during week 2. | Other | Normal Weight Participants, Obese Participants |
| Low Fat DietThe low fat diet will consist of 1200 kcal, 26g fat (20%), 78mg cholesterol, 150g carbohydrates (50%), and 100g protein (30%). The participants will be on this diet during week 4. | Other | Normal Weight Participants, Obese Participants |
Primary outcome
Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and High Fat Diet
Time frame: Baseline to approximately day 7 of week 2
Change in 48h-fecal bile acid excretion (μmol/L) between baseline and high fat diet
Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and Low Fat Diet
Time frame: Baseline to approximately day 7 of week 4
Change in 48h-fecal bile acid excretion (μmol/L) between baseline and low fat diet
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Andres J Acosta Cardenas principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Diet, High Fat Diet and Low Fat Diet in people with Obesity, run by Mayo Clinic 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?
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 27 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 27 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and High Fat Diet (time frame: Baseline to approximately day 7 of week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.