Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome

Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome

An enteral diet supplemented with ginger extract in acute respiratory distress syndrome (ARDS) patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and length of stay in intensive care unit (ICU).

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Dietary supplement: ginger; Dietary supplement: placebo

Detailed Description

Rationale: Clinical ARDS occurs primarily as the result of inflammatory injury to the alveoli producing diffuse alveolar damage.

Objective: To evaluate the effects of an enteral diet enriched with ginger extract on inflammatory factors, respiratory profile and outcome of patients with ARDS.

Methods: In this single center, randomized, controlled double blind study, 32 patients with ARDS were randomized to receive a high protein enteral diet enriched with ginger extract or placebo.

Measurements and Main Results: Serum levels of IL-1, IL-6, TNF-α and LTB-4, oxygenation, measured as PaO2/FiO2, static compliance measured on days 0, 5 and 10.

Patients fed enteral diet enriched with ginger extract had significantly lower serum levels of IL-1, IL-6, TNF-α and LTB-4 on days 5 and 10 compared to control group (P<0.05). Significant improvement in oxygenation was observed on day 5 (P=0.02) and 10 (P=0.003) in ginger extract group compared to control group. Static compliance was also increased significantly on day 5 (P=0.01) in ginger extract group compared to control group. A significant difference was found in duration of mechanical ventilation (P0.02) and length of ICU stay (P=0.04) in favor of ginger extract group. We did not find any difference in barotraumas, organ failure and mortality between the study groups.

Conclusions: An enteral diet supplemented with ginger extract in ARDS patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and length of stay in ICU.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Faculty of Nutrition Sciences and Food Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Required positive pressure ventilation via endotracheal tube or tracheostomy and were on enteral nutrition support.
• Also they had to have an acute onset of significantly impaired oxygenation with a PaO2 to FiO2 ratio equal or less than 200, bilateral pulmonary infiltrates on frontal chest radiograph and no clinical evidence of left atrial hypertension according to the American-European Consensus Conference on ARDS .
• Patients had to be enrolled within 48 hours of developing these criteria.

Exclusion Criteria:

• Age younger than 18 years
• Participation in other interventional trials in the previous 30 days
• Neurological conditions that could impair weaning from ventilatory support,
• Severe chronic respiratory disease
• Pregnancy
• Lactation
• Active bleeding
• Head trauma
• Intracranial hemorrhage
• Peptic ulcer
• HIV infection
• Food allergy
• Morbid obesity
• Malignancy or other irreversible conditions for which 6 months mortality was estimated to be 50% or more and who were receiving nonsteroidal anti inflammatory drugs or ketoconazole.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ginger; Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo	Dietary supplement: ginger; Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo; Other Names: Zingiber officinale
Experimental: placebo; Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo	Dietary supplement: placebo; Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo; Other Names: Zingiber officinale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in oxygenation, respiratory mechanics and serum inflammatory factors	21 days
oxygenation	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
the number of organ failure free days, the occurrence of barotraumas, the number of ventilator free days, the number of ICU free days and ICU mortality.	after intervention

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Investigators: Principal Investigator: zahra vahdat shariatpanahi, MD, Ph.D, Faculty of Nutrition Sciences and Food Technology

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: August 3, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Estimate): August 13, 2009
• Last Update Submitted That Met QC Criteria: August 12, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: mechanical ventilation; ICU; ARDS; enteral feeding; ginger extract
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: INFI-112