What does your participation in this FIU nutrition research (MetA-Bone Trial) entail?

Study Supplement

The fiber supplement is a common fiber sold in many pharmacies and also used in many foods. The fiber supplement comes in a tasteless powder form. Participants only need to add 1 scoop of the powder to any beverage of their choice. It will not change the flavor, color, or texture of the beverage. We also have the fiber supplement combined with a flavored sugary powder in case participants prefer it this way; participants only need to add 1 scoop to water. All participants need to drink this twice per day for 1 year.

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Participants will be randomized to 1 of 4 groups

Participants will be randomized into 1 of 4 groups:

Soluble corn fiber supplement
Soluble corn fiber supplement + calcium
Maltodextrin (placebo)
Maltodextrin (placebo) + calcium

All supplements come in powder, they are flavorless, and they are very similar in appearance. Participants just need to add 1 scoop to the beverage of their choice.

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Study visits

Parents and children are required to come to FIU 3 times (at baseline, at 6 months, and at 12 months) and we will meet with you at a convenient location 3 times as described below.

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All you need to know about the study visits:

Virtual orientation

(duration: 30 minutes)

We will call interested parents to explain the study. If parents and children agree to participate in the study, we will send the consent forms for review and signature.

After signing the consent forms, parents will be asked to complete the following online questionnaires:

Contact information
Health status
Food frequency questionnaire
Food recalls
Physical activity

3 FIU Visits

These 3 visits will be held at FIU’s Center for Children and Families.

1st FIU Visit: Baseline

(duration: 45 min)

We will measure the child’s height, weight, hip circumference, and neck circumference.
We will perform a bone scan of the child using the DXA machine. For this, he/she will lay down on a table while a low radiation bean scans his/her body for about 10 minutes (it is totally painless). We will provide parents with the results showing the breakdown of total bone, muscle, and fat mass. This is great for children who are athletes.
We will collect a small blood sample from the child. This will be performed by a trained phlebotomist and parents will receive the results for vitamin D, calcium, phosphorus, and creatinine.
We will provide instructions and materials for the child to collect urine and fecal samples at home. Parents will also receive these results.
At the end of the visit, we will provide monetary compensation for the child and the parent, breakfast for the child, and study tokens (bags, etc).
If the child and parent are interested and have time, we could do a tour of our labs to show how we conduct our studies at FIU.

2nd FIU Visit: at 6 months

(duration: 20-25 min)

We will measure the child’s height, weight, hip circumference, and neck circumference.
We will perform a bone scan of the child as described in the 1st visit.
At the end of the visit, we will provide monetary compensation for the child and the parent and study tokens (bags, etc).
If the child and parent are interested and have time, we could do a tour of our labs to show how we conduct our studies at FIU.

3rd FIU Visit: at 12 months

(duration: 45 min)

We will measure the child’s height, weight, hip circumference, and neck circumference again.
We will perform again a bone scan as described in the 1st visit.
We will collect again a small blood sample as described in the 1st visit.
We will ask you to bring the urine and fecal samples collected by the child at home (we will provide the materials in the previous drop-off visit).
We will provide monetary compensation to the parent and the child and also study tokens.
If the child and the parent are interested, we can do a tour of our labs to show how we conduct our studies at FIU.

3 short drop-offs visits

(duration: about 10 minutes)

A staff member will drive where is more convenient for you and perform the following at each visit:

1st Drop Off Visit: 1-2 weeks after Baseline

We will provide a 3-months supply of the assigned supplement.
We will pick up the urine and fecal samples collected by the child at home (we will provide the instructions and materials for this at the 1st visit).
We will provide the monetary compensation and the results of the blood sample and bone scan.

2nd Drop Off Visit: 3 months

We will collect left-over supplements and provide more supplements for the next 3 months.
We will provide monetary compensation and the results of the urine sample

3rd Drop Off Visit: 9 months

We will collect left-over supplements and provide more supplements for the next 3 months
We will provide monetary compensation and the results of the bone scan conducted at 6 months