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Low protein diet

Phase 1

Osteoporosis | Unknown | Endocrine |United Therapeutics Corporation|Last Updated: Mar 31, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

Low protein diet · 1 trial · 1 indication

Phase 1 1
NCT00671944Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium MetabolismOsteoporosis
COMPLETED11 Analytics
PHASE1COMPLETED
Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Calcium absorption and kinetics
Baseline, day 5 and week 6

Secondary Endpoints

Serum Parathyroid hormone
baseline and weekly
Markers of bone turnover
baseline and weekly
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLow protein diet

Interventions

NameTypeDescription
Low protein dietOTHERLow protein diet for 6.5 weeks
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Eligibility Criteria

Age Range20 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Asian or Caucasian women between the ages of 20-40 years. Exclusion Criteria: * Diseases or medical conditions: gastrointestinal diseases, osteoporosis, diabetes, hypertension, liver disease, thyroid disorders, kidney disease, kidney stones, cancer, heart disease, ea...

Countries:United States
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Competitive Landscape -Osteoporosis 8 trials

Frequently asked questions about Low protein diet

What is Low protein diet used for in Osteoporosis?

Low protein diet is an investigational nutritional intervention being studied for its effects on calcium metabolism in osteoporosis. It is a dietary approach, not a conventional drug, and is currently in Phase 1 clinical development. The therapy is being evaluated in a completed trial involving 11 female participants in the United States.

Who is developing Low protein diet?

Low protein diet is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker UTHR. The company is conducting clinical research to evaluate the effects of this nutritional intervention on calcium metabolism in the context of osteoporosis.

What phase is Low protein diet in?

Low protein diet is in Phase 1 clinical development. It is an investigational nutritional intervention, not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the product remains in early-stage clinical research for its potential use in osteoporosis.

What clinical trials is Low protein diet in?

Low protein diet has one completed clinical trial, NCT00671944, titled 'Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism.' This Phase 1 study enrolled 11 female participants in the United States and focused on osteoporosis. The trial was uncontrolled and not randomized or double-blinded.

Is Low protein diet FDA approved?

Low protein diet is not FDA approved. It is an investigational nutritional intervention currently in Phase 1 clinical development. The completed trial, NCT00671944, was an early-stage study, and the product has not yet received regulatory approval for any indication, including osteoporosis.