Intestinal Barrier FunctionNCT01686204
Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
A study testing Low fat dairy yogurt and Soy pudding in people with Intestinal Barrier Function and Chronic Inflammation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intestinal Barrier Function, Chronic Inflammation
- What is being tested?
- Low fat dairy yogurt and Soy pudding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 31 Mar 2017
- 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 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- premenopausal women
- BMI from 18.5-27 and 30-40 kg/m2
- resting blood pressure <140/90 mmHg
- not taking medication to control hypertension
- stable body weight for the previous 2 months
- willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling
- willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study
Who cannot join
- previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)
- currently being treated for cancer (i.e., chemotherapy, radiation therapy)
- prescribed estrogen replacement therapy
- practicing weight-loss, vegetarian, kosher, or vegan diets
- currently taking dietary supplements
- exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week)
Show all 10Show fewer
- actively using antibiotics
- taking anti-inflammatory drugs
- have allergies to soy, egg or milk
- perimenopausal or menopausal symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science, Babcock Hall
Madison, Wisconsin, 53706
About this study
The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.
- Conditions
- Intestinal Barrier Function, Chronic Inflammation
- Being tested
- Low fat dairy yogurt, Soy pudding
- Keywords
- Yogurt, Intestine, Inflammation, Obese
- Medical subject headings
- Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat dairy yogurtOther
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
Soy puddingOther
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Non-obese individuals | Active comparator | Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks. Receives: Other: Low fat dairy yogurt; Other: Soy pudding |
| Obese individuals | Experimental | Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks. Receives: Other: Low fat dairy yogurt; Other: Soy pudding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma soluble cluster of differentiation 14 (sCD14)
Fasting plasma sCD14 (change from baseline)
Measured: 0, 3, 6, and 9 wk
Secondary outcomes (3)
Fasting plasma interleukin-6 (IL-6)
Fasting plasma IL-6 (change from baseline)
Measured: 0, 3, 6, 9 wk
Postprandial sCD14
Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)
Measured: 0 and 9 wk
Postprandial interleukin-6 (IL-6)
Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)
Measured: 0 and 9 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion30 Sep 2016
- Study completion31 Mar 2017
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 Intestinal Barrier FunctionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Research Institute
- Responsible party
- Sponsor
- Investigators
- Bradley W Bolling, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686204
- Sponsor's protocol ID
- 2014-0669
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2012
- Last updated
- 3 Oct 2017
- Results posted
- No
Publications
Pei R, DiMarco DM, Putt KK, Martin DA, Chitchumroonchokchai C, Bruno RS, Bolling BW. Premeal Low-Fat Yogurt Consumption Reduces Postprandial Inflammation and Markers of Endotoxin Exposure in Healthy Premenopausal Women in a Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):910-916. doi: 10.1093/jn/nxy046.
PubMed 29767743Pei R, DiMarco DM, Putt KK, Martin DA, Gu Q, Chitchumroonchokchai C, White HM, Scarlett CO, Bruno RS, Bolling BW. Low-fat yogurt consumption reduces biomarkers of chronic inflammation and inhibits markers of endotoxin exposure in healthy premenopausal women: a randomised controlled trial. Br J Nutr. 2017 Dec;118(12):1043-1051. doi: 10.1017/S0007114517003038. Epub 2017 Nov 28.
PubMed 29179781
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
- ClinicalTrials.gov ID
- NCT01686204
- Acronym / sponsor ID
- 2014-0669
- Conditions
- Intestinal Barrier Function, Chronic Inflammation
- Keywords
- Yogurt, Intestine, Inflammation, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Dairy Research Institute
- Study start
- Sep 2012
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 17 Sep 2012 (estimated)
- 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.
The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-obese individuals | Active comparator | Other: Low fat dairy yogurt, Other: Soy puddingDaily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks. |
| Obese individuals | Experimental | Other: Low fat dairy yogurt, Other: Soy puddingConsumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- premenopausal women
- BMI from 18.5-27 and 30-40 kg/m2
- resting blood pressure <140/90 mmHg
- not taking medication to control hypertension
- stable body weight for the previous 2 months
Key exclusion criteria (10 listed)
- previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)
- currently being treated for cancer (i.e., chemotherapy, radiation therapy)
- prescribed estrogen replacement therapy
- practicing weight-loss, vegetarian, kosher, or vegan diets
- currently taking dietary supplements
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 |
|---|---|---|
| Low fat dairy yogurtConsumption of 12 oz of low fat dairy yogurt daily for 9 weeks | Other | Non-obese individuals, Obese individuals |
| Soy puddingConsumption of 12 oz of low fat soy pudding daily for 9 weeks. | Other | Non-obese individuals, Obese individuals |
Primary outcome
Plasma soluble cluster of differentiation 14 (sCD14)
Time frame: 0, 3, 6, and 9 wk
Fasting plasma sCD14 (change from baseline)
3 secondary outcomes
Fasting plasma interleukin-6 (IL-6)
Time frame: 0, 3, 6, 9 wk
Postprandial sCD14
Time frame: 0 and 9 wk
Postprandial interleukin-6 (IL-6)
Time frame: 0 and 9 wk
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 3 Oct 2017.
- Derived from this study: PubMed 29767743Pei R, DiMarco DM, Putt KK, Martin DA, Chitchumroonchokchai C, Bruno RS, Bolling BW. Premeal Low-Fat Yogurt Consumption Reduces Postprandial Inflammation and Markers of Endotoxin Exposure in Healthy Premenopausal Women in a Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):910-916. doi: 10.1093/jn/nxy046.
- Derived from this study: PubMed 29179781Pei R, DiMarco DM, Putt KK, Martin DA, Gu Q, Chitchumroonchokchai C, White HM, Scarlett CO, Bruno RS, Bolling BW. Low-fat yogurt consumption reduces biomarkers of chronic inflammation and inhibits markers of endotoxin exposure in healthy premenopausal women: a randomised controlled trial. Br J Nutr. 2017 Dec;118(12):1043-1051. doi: 10.1017/S0007114517003038. Epub 2017 Nov 28.
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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.
Bradley W Bolling, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat dairy yogurt and Soy pudding in people with Intestinal Barrier Function and Chronic Inflammation, run by University of Wisconsin, Madison 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 10 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 3 Oct 2017. 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?
Plasma soluble cluster of differentiation 14 (sCD14) (time frame: 0, 3, 6, and 9 wk). 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 NCT01686204, 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 3 Oct 2017.