NCT02561143

Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients

To Evaluate the Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Delaying Progression of Cachexia to Refractory Cachexia in Adult Cancer Patients in Indian Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Westminster · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigators are evaluating the nutritional role of IAtta supplementation along with nutritional counselling in delaying the progression of cachexia to refractory cachexia in adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100 g) for daily consumption for 6 months. Dietary and physical activity counseling will be imparted every fortnight to patients. Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at baseline, after 3 months and at 6 months of intervention for all patients. Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary and physical activity counselling) for six months will improve the health status and quality of life in free-living patients suffering from cancer cachexia.

Detailed description

Patients will be randomly distributed into two groups i.e. control and intervention group. 75 patients will be allocated in intervention group and receive nutrient rich flour mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 75 patients will be allocated in the control group who will receive whole wheat flour with dietary and physical activity counseling. Intervention group patients will collect 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients will collect 14 packets of 100 g of whole wheat flour at every clinician visit for 6 months. Dietary counseling for 30 minutes will be imparted to all patients on each visit by the nutritionist. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions. Nutritional, biochemical, quality of life and anthropometric estimations would be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Conditions

• Cachexia
• Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Improved Atta	Improved Atta is a multi macro- micronutrient bread mix. Patients will be given 100 grams of Improved Atta (to make unleavened bread) everyday for consumption for six months.
DIETARY_SUPPLEMENT	Wheat flour	Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.
BEHAVIORAL	Physical activity counseling	Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.
OTHER	Nutritional counseling	Dietary counseling for 30 minutes will be imparted to all patients on every hospital visits by the nutritionist. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) will be encouraged in their daily diets.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-11-01
• Completion: 2016-05-01
• First posted: 2015-09-25
• Last updated: 2017-06-22

Locations

2 sites across 2 countries: India, United Kingdom