Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05350579 |
| Other study ID # |
18-095-MAN |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 28, 2019 |
| Est. completion date |
March 25, 2020 |
Study information
| Verified date |
April 2022 |
| Source |
University of Massachusetts, Lowell |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Caribbean Latino adults are a vulnerable population at risk for developing osteoporosis. In
addition to lifestyle factors, such as dietary intake, the investigators hypothesize that a
unhealthy gut microbial environment coupled with high inflammation contributes to the risk of
developing osteoporosis. There has been little research conducted on mechanisms underpinning
how a low-intensity dietary intervention, including supplementation with daily yogurt, can
affect the gut health of Caribbean Latino adults. The study objectives are to: 1) determine
whether daily yogurt supplementation reduces bone turnover (biomarkers of overall bone
health) and inflammation compared to a control group that maintains their usual diet (void of
yogurt); and 2) collect preliminary data on the effects of daily yogurt supplementation on
the gut microbiome compared to diet control group.
Description:
Recruitment:
A total of 40 Caribbean Latino men and women ≥50 y will be recruited and enrolled from
Greater Lawrence, MA, USA. Subjects will be recruited using flyers distributed throughout the
communities including Senior Centers and other community organizations and agencies. The
study team will also set up tables/booths at local festivals and community events. Interested
participants will be directed to call a study-center call line to learn more about the study
and to be screened for inclusion, if interested. For those who are eligible, the study team
member will schedule the first interview, which will include obtaining consent.
Intervention Protocol:
40 study participants will undergo 12 study visits at the Lawrence Senior Center. They will
first undergo a 4-week wash in baseline period. Participants will then undergo a two-month
intervention (yogurt supplementation or control [maintenance of usual diet]). The study
period will include weekly interviews (12 visits in total).
Baseline Month First interview (visit -3) in week 1 of the baseline month participants will
be provided written informed consent. A trained bilingual interviewer will describe the study
and answer any questions participants may have. The interviewer will also be available to
read the consent form to participants in the event that he/she is unable to read. The consent
forms will be stored in a locked file cabinet inside of a locked office at UMass Lowell.
During the first visit, a trained bilingual interviewer will complete a baseline
questionnaire, a 24-hour dietary recall where the interviewer will record all foods eaten by
participants the previous day, and complete physical assessment measures, such as height and
body weight. Participants will be provided fecal collection materials and the interviewer
will instruct participants on the proper aseptic technique for fecal collection (see
collection methods section). The interview will collect the fecal tube at the next visit
(week 2 of the baseline month). The first interview will take approximately 2 hours to
complete.
Interviews in week 2 and 3 of the baseline month (visits -2, -1): At each interview, the
trained interviewer will collect the fecal sample and provide a new collection kit for the
following visit. A 24-hour dietary recall will be completed and a physical assessment
measures will be obtained. These interviews will take approximately 1 hour to complete.
Interview in week 4 of the baseline month (visit 0): During this visit, the trained
interviewer will collect the fecal sample and provide a new collection kit for the following
visit. A 24-hour dietary recall will be completed and physical assessment measures will be
obtained. A certified phlebotomist will collect 23 milliliters of blood for baseline data on
inflammation and bone turnover. This interview will take approximately 1½ hours to complete.
Intervention Months 1 and 2 (8 weeks total): Upon completion of 4-week baseline period,
participants will be randomly assigned to intervention and control groups by a project
manager not associated with the project (study manager of the Center for Population Health,
University of Massachusetts, Lowell). This study manager will randomize de-identified
participants to either intervention or control at random to ensure an even number of men and
women in each group. They will then participate in 8 weekly interviews with a trained
bilingual interviewer. The intervention group will be provided their yogurt weekly (7, 5
ounce containers per week) and will be asked to bring back empty yogurt containers to their
next visit.
Interview in week 1 of Intervention Month 1 (visit #1):
During the week 1 visit, participants will complete a 24-hour dietary recall performed by a
trained bilingual interviewer and will also undergo a physical assessment of their weight and
height. Participants will be provided with their yogurt for the week and a fecal collection
kit and instructions. The fecal sample will be picked up the following week by the study
interviewer. This interview will take approximately 1 hour to complete.
Interview in week 2-7 of Intervention Months 1 & 2 (visits 2-7) Participants will complete 6
weekly interviews. The trained interviewer will collect the fecal sample, provide new fecal
sample kit, administer a 24-hour dietary recall and obtain weight and height measures. If in
the yogurt intervention group, participants will receive an additional week of yogurt. At
each follow-up interview, the participants will be asked by the trained interviewer if they
have gas, bloating or any feelings of gastrointestinal discomfort or signs of allergy after
eating the yogurt. If the participant responds "yes", the trained interviewer will document
the participant's symptoms on the Adverse Event sheet (attached) and will then notify the PI.
The PI (Registered Dietitian) will call the participant to inquire further about the symptoms
and decide with the participant if they should remain in the study. All AEs will be reported
to the IRB within 24h of participant report to the PI. Participants in the control group will
be reminded to continue their usual diet and abstain from yogurt intake. These interviews
will take approximately 1 hour each to complete.
Interviews week 4 of Intervention Month 2 (final visit 8):
During this interview, the trained interviewer will collect the fecal sample. A 24-hour
dietary recall will be completed and physical assessment measures will be obtained. A
certified phlebotomist will collect 23 milliliters of blood for baseline data on inflammation
and bone turnover. This interview will take approximately 1 ½ hours to complete.
Additional Information on Data Collection Measures:
1. Study Questionnaire (collected during week 1 of the wash-in period): This questionnaire
will ask participants to report their age, sex, education, income, marital status,
employment status and place of birth, questions on health history (e.g., told by a
health care provider if they have health conditions such as diabetes, osteoporosis, and
cancer), health behaviors (smoking, alcohol consumption, physical activity, and
medication use) will be obtained and intakes of vitamin D and calcium will also be
assessed.
2. Twelve, 24-hour Dietary Recalls: The investigators will obtain dietary data using an
automated multiple-pass interview method in conjunction with the University of Minnesota
Nutrition Data System (NDS) software. The USDA automated multiple-pass method is a
computerized method of collecting 24-hour dietary recalls. This method is completed by a
trained interviewer either in person or by telephone and is designed to reduce
respondent burden. This approach uses 5 steps to collect information about food and
beverages consumed over the past 24 hours, as follows:
Step 1: Collect a list of foods and beverages consumed the previous day (quick list).
Step 2: Probe for foods and beverages forgotten during the quick list. Step 3: Collect
time and eating occasion for each food reported Step 4: For each food, collect a
detailed description, amount consumed and any additions to the food such as milk on
cereal or cream in coffee.
Step 5: Conduct a final probe for anything else consumed.
This information will be entered directly into the computer system by the trained
interviewer. The trained bilingual interviewer will administer the 24-h recall during
the interviews and will enter dietary data directly into a computer. Food models will be
used to help participants in estimating portion sizes.
3. Blood sample: 23 milliliters of blood will be taken at the end of the baseline period
(week 4, baseline, visit 0), and again at the end of the 8-week intervention (week 4,
Interview Month 2, visit 8). Blood samples will be obtained at the Lawrence Senior
Center by a certified phlebotomist. Samples will be transported in temperature
controlled containers immediately after blood draw, and stored at the UML in a freezer
at -20℃ until laboratory analysis.
4. Fecal Samples: Participants will be asked to collect a fecal sample at their home using
standardized procedures with Omnigene Gut kits.
a. The stool collection kit will contain: i. Gloves ii. Marker iii. Stool collection hat
iv. One stool collection OMNIgene•Gut (DNA genotek, Canada). The kit includes the
collection device showed in Figure 1.
v. Paper instructions with images vi. Brown paper bags vii. Plastic container with tight
seal
Collection Methods Specimen Labeling: The collection tube provided in the kit will have
a customized easy to fill up label that will be use to provide specific information
about the sample: date, time of the day, and consistency of the samples.
The kit will be inspected for integrity and cleanliness prior to sample collection
before labeling. In case of noticing lack of integrity, the device should be discarded
and another collection device should be used. Participants will fill the label with the
appropriate information: month, day, time and fecal consistency.
Specimen collection: If needed the participant should urinate before the fecal
collection to avoid sample contamination with urine. Then, the stool collection hat
should be placed on the toilet as shown in Figure 3. Following patients should deposit
the stools into the hat. Once finish, the purple cap will be unscrew for the
OMNIgene•Gut collection. The collection device will be kept straight up in one hand, and
with the other hand, the samples will be collected from the stool collection using the
spatula provided in the kit. The purple top of the collection device will be filled
completely. Any excess will be scraped off with the spatula, and the purple cap will be
then screwed back tightly. The tubes will be shaken for at least 30 seconds until the
samples do not contain large particles. Then samples will be bagged (brown paper bags
will be provided for privacy) and place it in the plastic container also provided.
Samples will be kept in the participant's refrigerator (or any cool, dark, dry space) up
to 7 days.
Participants will bring their samples to each subsequent interview. The samples will be
stored at UML in a -80 degree freezer until all samples are collected. Samples will be
placed on dry ice and driven by an investigator to the Center for Microbiome Research
laboratory at UMass Medical School for analysis using 16S rRNA sequencing.
Translation: The screening form, recruitment flyer, questionnaire on sociodemographic,
health and health behaviors and informed consent form will be translated to Spanish by a
bilingual staff member in our Center for Population Health and Health Disparities. All
materials will be back translated by bilingual staff at the Lawrence Senior Center. A
signed copy of the "Certificate of Translation" will be submitted to the IRB once
completed.
5. Describe the participant population: 40 Caribbean Latino adults age ≥50y will be
recruited by flyers displayed in the Lawrence Multi-Purpose Senior Center. The senior
center serves approximately 200-400 adults per day (over 5000 yearly). 75% of those
served are considered Hispanic with the majority of Hispanics coming from Caribbean
descent.
6. Recruitment Information
1. Participants will be recruited posting flyers around the Lawrence Multi-Purpose
Senior Center and other community organizations and agencies. The study team will
also set up tables/ booths at local festivals and community events.
2. Sample size calculation: Based on data from Hooshman and colleagues 2011 published
in the British Journal of Nutrition, sample size was calculated for absolute
difference in osteocalcin between two dietary supplemented groups (OC after
intervention with dried plums 17.19 +- 0.7 vs. OC after intervention with dried
apples 15.6 +- 0.6) as >0.99 with 20 people per group. In addition, effect sizes
were used from the same study for CRP in the dried plum group (20.5 +- 3.0) and the
dried apple group (14.9 +- 3.0) and provided a power >0.99 with a sample size of 20
per group.
7. Collaborators:
i. The investigators are collaborating with the Lawrence Multipurpose Senior Center and
City of Lawrence Mayor's Health Task Force team for research effort support. The Senior
Center will serve as the study site, as well as provide support for recruitment and will
provide a study staff member for interviews and blood & fecal collection.
ii. The investigators will also collaborate with the UMass Medical School, Center for
Microbiome Research. Dr. Ana Luis Maldonado is our primary contact at the Center and
will provide her expertise on the microbiome for fecal sample collection, analysis, and
interpretation of results. All fecal samples will be sent to the UMass Medical School
for analysis. Data will be de-identified and coded by study ID number.
