NCT02664623

Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients

Effectiveness of Personalized Nutrition Advice Delivered Via Dietary Consultations for Optimizing Dietary Calcium Intake in Patients With Multiple Sclerosis (MS) and Monitored as Outpatients: a Randomized, Single-blind, Bicentric Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to measure effectiveness at 6 months of personalized dietary advice versus dietary counseling via delivery of a standard advice sheet for optimizing dietary calcium intake (assessed by a food survey based on CIQUAL\* data) in MS patients with ambulatory monitoring. \*CIQUAL Data: Table of nutritional food composition available on the ANSES (National Agency for Sanitary Security of Food, Environment and Labour) website, published by the Observatory of the Nutritional Quality of Foods. This table includes 1,500 sheets of 58 nutritional components. The data is integrated into the software for calculating ingesta (DATAMEAL) at the Nîmes University Hospital.

Detailed description

The secondary objectives of this study is to compare the two groups in order to: A- correlate the impact of the recommendations by sheet or consult with disability, cognitive status, fatigue, depression, quality of life of patients with MS. B- assess the prevalence of diet changes as an alternative therapy for lactose intolerance in the population and to correlate these changes with dietary calcium intake at baseline (assessed by a food survey based on CIQUAL\* data). C- assess calcium intake of the patients included via the self-administered frequency questionnaire QALCIMUM® on day 0 and 6 months and to compare them with data obtained by the food survey based on data from CIQUAL. D- correlate calcium intake of the patients with vitamin D levels at inclusion and establish a biological collection of blood samples from the population.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
PROCEDURE	Individual dietary consultations	Individual dietary consultations with a dietician will be held at inclusion, month 1 and month 3. Consults consist of a personal interview where the dietician delivers comprehensive information to the patient on how to optimize calcium intake and reduce the risk of fractures; the dietician questions the subject on his/her diet and reassesses the quality and quantity of calcium intake during the 3 days preceding the consultation through a survey calculation software based on data from CIQUAL.
PROCEDURE	Dietary advice sheet	At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".

Timeline

• Start date: 2016-07-13
• Primary completion: 2020-01-06
• Completion: 2020-01-06
• First posted: 2016-01-27
• Last updated: 2025-12-01

Locations

2 sites across 1 country: France