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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN84079151
Date of registration: 05/02/2016
Prospective Registration: No
Primary sponsor: UPM Un Punto Macrobiotico International Association (Italy)
Public title: Treatment of reactive hypoglycemia with macrobiotic Ma-Pi 2 diet as assessed by continuous glucose monitoring system
Scientific title: A randomized crossover trial to assess the effect of the Ma-Pi 2 MAcrobiotic diet in the treatment of reactive HYPoglycemia with continuous glucose monitoring system (MAHYP)
Date of first enrolment: 01/10/2014
Target sample size: 12
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN84079151
Study type:  Interventional
Study design:  Interventional crossover single-centre trial (Treatment)  
Phase: 
Countries of recruitment
Italy
Contacts
Name: Paolo    Pozzilli
Address:  Via Alvaro del Portillo 21 00128 Rome Italy
Telephone: +39 (0)6 22541 9184
Email: p.pozzilli@unicampus.it
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Non-diabetic patients
2. Both sexes
3. Aged at least 18 years old
4. BMI between 18 and 35 kg/m2
5. Able to provide written informed consent and to follow the procedures of the protocol
6. Previous diagnosis of RH, though it was confirmed by MMT before the enrolment

Exclusion criteria: 1. Impaired fasting glucose/impaired glucose tolerance/diabetic patients
2. Subjects affected by insulinoma or by other hypoglycemic endocrine conditions
3. Patients affected by any neoplasia
4. Patients affected by any food behavior disorders
5. Pregnant women
6. Symptoms of hypocalcemia
7. Known or suspected hypersensitivity to any of the ingredients of the administered diets
8. Patients under vitamin K antagonists or corticosteroid treatment
9. Subjects under any drugs therapy which might interfere with glucose metabolism


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Reactive hypoglycemia
Nutritional, Metabolic, Endocrine
Intervention(s)
The subjects enrolled in the study are randomized and consequently divided into two homogeneous groups to receive the two dietary treatments in opposite sequence. Over a period of 6 days they are lodged in a farm in Italy, where they receive all daily meals (Ma-Pi 2 Macrobiotic meals or a control low-GI diet for reactive hypoglycemia).
Anthropometrical measurements will be carried out at baseline and after 6 days of the dietary interventions. Glucose profile measurements will be performed throughout the trial by using continuous glucose monitoring and glucometers.
Primary Outcome(s)
Reduction of the number of episodes of reactive hypoglycemia (blood glucose level below 70 mg/dL) in patients affected by such condition during macrobiotic Ma-Pi 2 diet administration compared to a same period during the administration of a low-GI diet.
Secondary Outcome(s)
Glycemic distributions assessment through different readings (< 40; 41-50; 51-60; 61-70, 71-80, 81-90, 91-100, 101-110, 111-120, 121-130, 131-140, 141-150, 151-160, 161-170, 171-180 and > 180 mg/dL), measured and compared between the two dietary treatments
Secondary ID(s)
51/14
Source(s) of Monetary Support
UPM Un Punto Macrobiotico International Association (Italy)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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