TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03569813

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: PrEP@Home System
Description: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).~The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).~Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care
Description: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
Study: NCT01592747

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Memantine Hydrochloride (HCl)
Description: Extended Release Dose ranging from 3-15mg/day; administered orally
Study: NCT01889758

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Generic Hi: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Generic Hi: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Generic Hi: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Generic Lo: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Generic Lo: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Generic Lo: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).
Study: NCT04780451

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Omega-3 supplementation in recreational runners
Description: Male recreational runners participated in 12 weeks of endurance training combined with omega-3 fatty acids supplementation. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Omega-3 supplementation in recreational runners
Description: Male recreational runners participated in 12 weeks of endurance training combined with omega-3 fatty acids supplementation. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
Study: NCT02464904

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cryotherapy
Description: Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). The procedure will involve 2 to 3 applications of cryospray on the location of the disease. After establishing cryofrost over a minimum of a 2 x 2 cm area, cryospray will continue for 15 to 20 seconds, allow a thaw period of 60 seconds followed by one to two repeats in the same location before proceeding onto the next location. We will treat a minimum of 6 x 6 cm area in aggregate. The freezing procedure will be video-recorded and freezing locations and time will be recorded. Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection.

Intervention type: OTHER
Group type: OTHER
Intervention: Control
Description: Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection
Study: NCT01556906

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lomitapide
Description: Oral administration with escalating doses administered once daily
Study: NCT00651651

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: budesonide/formoterol

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: budesonide

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: formoterol
Study: NCT02032927

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Codeine/paracetamol
Description: Randomization to one of the two treatments will be done through appropriate randomization list.~During the first 15 days of treatment in the event of failure of efficacy, understood as the average pain intensity higher than 4 (monitored with NRS) with the need to take more than two rescue doses of paracetamol per day, and in the absence of side effects, the patients will be instructed on how to proceed with dosage adjustments according to specific guidelines.~The patient will be evaluated at 15 days, 1 month, 2 months and three months. Your health care professional who administer the assessment scales (WOMAC, SF-12, BFI, TMT) will not know in any way which treatment the patient is taking.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxycodone/naloxone
Description: Randomization to one of the two treatments will be done through appropriate randomization list.~During the first 15 days of treatment in the event of failure of efficacy, understood as the average pain intensity higher than 4 (monitored with NRS) with the need to take more than two rescue doses of paracetamol per day, and in the absence of side effects, the patients will be instructed on how to proceed with dosage adjustments according to specific guidelines.~The patient will be evaluated at 15 days, 1 month, 2 months and three months. Your health care professional who administer the assessment scales (WOMAC, SF-12, BFI, TMT) will not know in any way which treatment the patient is taking.
Study: NCT00842309

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: d-cycloserine
Description: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Study: NCT02448563

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Nutrition and physical activity education
Description: Eight weekly in-person groups
Study: NCT03965065

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Sutureless aortic bioprosthesis
Description: Patients will receive a sutureless aortic bioprosthesis

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Conventional stented sutured aortic prosthesis
Description: Patients will receive a stented sutured aortic prosthesis
Study: NCT03454737

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: mesenchymal stem cells
Description: Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out.~The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Pure platelet-rich plasma
Description: Under aseptic conditions, in surgical medium, 6 ml of P-PRP will be obtained from 36 ml of autologous peripheral venous blood sample.~The plasma coagulation will be activated by the addition of Cl2Ca at a concentration of 5%.
Study: NCT03373630

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Midline catheter
Description: The catheter will be inserted according to usual practices, after the enrollment of the patient in the study. The follow-up will last until the removal of the catheter, which will also be done according to usual practices. Following the removal, bacteriologic analyses will be performed in order to diagnose any prospective infection.
Study: NCT03312894

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-653
Description: TAK-653 tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-653
Description: TAK-653 tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo-matching tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo-matching tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo-matching tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo-matching tablets
Study: NCT01426334

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dasatinib
Description: Given PO

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: diagnostic laboratory biomarker analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclosporine
Description: Given PO
Study: NCT02070523

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: VDCLD regimen

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VDCLD regimen
Study: NCT01213407

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trivax, Temozolomide, Surgery, Radiotherapy
Description: Trivax: 5 x 10e6 dendritic cells, intranodal in 500 µl NaCl, weeks 7, 8, 9, 10, 12, 16, 20, 24, 28, 32~Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy~Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6.~Break: weeks 7, 8, 9, 10.~Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Temozolomide, Surgery, Radiotherapy
Description: Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy~Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6~Break: weeks 7, 8, 9, 10~Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31
Study: NCT03601845

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Stimuli
Description: Visual stimulation while using additional sequencing

Intervention type: OTHER
Group type: OTHER
Intervention: No stimuli
Description: Additional sequencing only
Study: NCT03297151

Intervention type: DIETARY_SUPPLEMENT
Group type: SHAM_COMPARATOR
Intervention: CONTROL
Description: Food grade mixture of non-essential amino acids in powdered form, flavoured and instantised to be dissolved in water.~Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10955

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Whey Protein Concentrate
Description: Whey protein concentrate in powdered form, flavoured and instantised to be dissolved in water.~Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Trade name of product is Carbelac80 Instant Product Reference Number 10431

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Whey Protein Hydrolysate
Description: Whey protein concentrate hydrolysate (degree of hydrolysate 27%) in powdered form, flavoured and instantised to be dissolved in water.~Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10468
Study: NCT03506087

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Advance care planning coaching session.
Description: A 60-minute in-person coaching session. The advance care planning coach, trained in motivational interviewing, will use a flexible script and checklist to assess the participant's readiness to engage in advance care planning and guide the participant forward in the process, proceeding at the participant's pace. Some participants may complete advance directives while others will not get that far. Some participants may receive a follow-up session 2-4 weeks later. Typically this 20 to 30-minute conversation will be by phone, but it may be conducted at the clinic as indicated for the participant.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Printed advance care planning materials
Description: Participants are provided with a folder containing an advance care planning guide developed by the Coalition for the Supportive Care of Kidney Patients for persons with Chronic Kidney Disease. The patient folder also contains the advance directive form used by the clinic that is appropriate to the state.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Printed advance care planning materials
Description: Participants are provided with a folder containing an advance care planning guide developed by the Coalition for the Supportive Care of Kidney Patients for persons with Chronic Kidney Disease. The patient folder also contains the advance directive form used by the clinic that is appropriate to the state.
Study: NCT01767909

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Insulin (Humulin® R U-100)
Description: 20 IU bid taken twice daily (approximately 30 minutes after breakfast and dinner) for a total of 40 IU daily, which will be administered intranasally. The device used to administer insulin releases a metered dose into a chamber covering the participant's nose. The insulin is then inhaled by breathing evenly over a specified period.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo taken twice daily (approximately 30 minutes after breakfast and dinner), which will be administered intranasally. The device used to administer placebo releases a metered dose into a chamber covering the participant's nose. The placebo is then inhaled by breathing evenly over a specified period.
Study: NCT02639182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGS-16C3F
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Axitinib
Description: Oral
Study: NCT01853176

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liposomal Injection Bupivacaine (Exparel)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Standard bupivicaine
Study: NCT01449409

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Real-time asthma care outreach
Description: Real-time asthma care identification of uncontrolled asthma and real-time notification of patients and their physicians of uncontrolled asthma and directions to improve care. Patients without an asthma specialist visit in the prior 3 years are offered an expedited allergy department referral.
Study: NCT02957578

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Solo TTD
Description: Placement of tympanostomy tube with Solo TTD
Study: NCT02095522

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Colchicine
Description: Colchicine 1mg per day for one month
Study: NCT04458883

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cardiac Magnetic Resonance Imaging
Description: Cardiac Magnetic Resonance Imaging - Cardiac Scan
Study: NCT02890290

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Marine Protein hydrolysate
Description: The participants will take the supplement in form of tablets and will be instructed to take five tablets twice a day, preferably in relation to meals, however, not the dinner meal. Each tablet contains 300 mg of marine protein hydrolysates (Nx6.25). The tablets are produced by Flexipharma AS.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo tablets will be made based on gum arabicum. The tablets are produced by Flexipharma AS.
Study: NCT00002664

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: edrecolomab

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: sargramostim
Study: NCT04448873

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sirolimus
Description: After at least 2 years of remission of KHE, we compare guided discontinuation with maintenance treatment in pediatric patients with KHE.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sirolimus
Description: After at least 2 years of remission of KHE, we compare guided discontinuation with maintenance treatment in pediatric patients with KHE.
Study: NCT02809521

Intervention type: OTHER
Group type: OTHER
Intervention: Activity Liking
Study: NCT04165811

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise treatment
Description: A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Counselling
Description: Only physical activity counseling will be given to the subjects in this group.
Study: NCT03902106

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: salbutamol
Description: subjects ingest salbutamol

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: exercise
Description: subjects undergo 6 weeks of endurance training (3 times weekly)

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: exercise
Description: subjects undergo 6 weeks of endurance training (3 times weekly)
Study: NCT02780219

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: stable amino acid infusion
Description: stable isotopes Such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously
Study: NCT01592747

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Memantine Hydrochloride (HCl)
Description: Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo capsules
Description: Once daily, oral administration.
Study: NCT02780219

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 24-hour post exercise amino acid infusion
Description: stable isotopes such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously
Study: NCT00519298

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SAM-531
Description: dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: placebo

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Donepezil
Description: dosage form: 5 mg encapsulated tablets one single dose of 5 mg.
Study: NCT00896636

Intervention type: PROCEDURE
Intervention: Random fine need aspiration (rFNA)
Description: Deep infiltration into the tissue of each breast with up to a 21 gauge needle attached to a syringe with about 4-5 passes at each location (up to 8-10 passes per breast) under local anesthesia (lidocaine).

Intervention type: PROCEDURE
Intervention: Random fine need aspiration (rFNA)
Description: Deep infiltration into the tissue of each breast with up to a 21 gauge needle attached to a syringe with about 4-5 passes at each location (up to 8-10 passes per breast) under local anesthesia (lidocaine).

Intervention type: PROCEDURE
Intervention: Random fine need aspiration (rFNA)
Description: Deep infiltration into the tissue of each breast with up to a 21 gauge needle attached to a syringe with about 4-5 passes at each location (up to 8-10 passes per breast) under local anesthesia (lidocaine).

Intervention type: OTHER
Intervention: Mammogram
Description: Standard mammography of both breasts to obtain images for breast density measurement.
Study: NCT04458883

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Fast Field Cycling - Magnetic Resonance Imaging
Description: Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Fast Field Cycling - Magnetic Resonance Imaging
Description: Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Electrocardiogram
Description: Electrocardiogram

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Echocardiogram
Description: Echocardiogram
Study: NCT03530774

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: powdered egg white protein supplement
Description: consumption of egg white protein supplement daily for 6 months

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: maltodextrin supplement
Description: consumption of maltodextrin supplement daily for 6 months