Plain English Summary
Background and study aims
Reactive hypoglycemia (RH) is a disorder where levels of glucose (sugar) in the blood become dangerously low following a meal (called hypoglycemic episodes). Nutritional therapy is recommended for people affected by RH. The macrobiotic Ma-Pi 2 diet is a nutritional therapy that improves glucose control in people with type 2 diabetes. The aim of this study is to investigate whether the Ma-Pi 2 diet improves blood glucose levels in patients affected by RH.
Who can participate?
Patients diagnosed with RH, aged 26 to 65.
What does the study involve?
Patients are randomly allocated to one of two groups. One group receives the control (low-glycemic index) diet for 3 days followed by the macrobiotic Ma-Pi 2 diet for a further 3 days. The other group receives the Ma-Pi 2 diet and then the control diet. All participants' blood glucose levels are measured throughout the study by using continuous glucose monitoring devices and glucometers.
What are the possible benefits and risks of participating?
There may be immediate direct benefits to the subjects participating - i.e. reduction of the number of hypoglycemic episodes. The main risk could be a drastic decrease in glucose levels and to avoid it participants will be strictly monitored by the doctors and specialists involved.
Where is the study run from?
The Endocrinology Area of the University of Campus Biomedico of Rome (Italy).
When is the study starting and how long is it expected to run for?
February 2014 to February 2015
Who is funding the study?
UPM Un Punto Macrobiotico International Association (Italy)
Who is the main contact?
1. Professor Paolo Pozzilli (p.pozzilli@unicampus.it)
2. Dr Andreea Soare (a.soare@unicampus.it)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Paolo Pozzilli
ORCID ID
Contact details
Via Alvaro del Portillo 21
Rome
00128
Italy
+39 (0)6 22541 9184
p.pozzilli@unicampus.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
51/14
Study information
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)
Acronym
MAHYP
Study hypothesis
This study is designed to determine whether short-term administration of the macrobiotic Ma-Pi 2 diet improves metabolic control in non-diabetic subjects affected by reactive hypoglycemia (reduction of the number of hypoglycemic episodes and assessment of glycemic distributions through different readings by continuous glucose monitoring system) compared with a low-GI diet for reactive hypoglycemia – to date, there is no diet for treating this condition.
The null hypothesis is that there will be no reduction of the number of hypoglycemic episodes or that there will be no difference according to the dietary sequence administered.
Ethics approval
The Ethics Committee of the University Campus Bio-Medico of Rome, 30/09/2014, prot. 51/14
Study design
Interventional crossover single-centre trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Reactive hypoglycemia
Intervention
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.
Intervention type
Other
Phase
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/10/2014
Overall trial end date
28/02/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant 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
Recruitment start date
01/10/2014
Recruitment end date
31/01/2015
Locations
Countries of recruitment
Italy
Trial participating centre
Campus Bio-Medico University of Rome
Via Alvaro del Portillo 21
Rome
00128
Italy
Sponsor information
Organisation
UPM Un Punto Macrobiotico International Association (Italy)
Sponsor details
Via San Nicola 9
Tolentino
62029
Italy
+39 (0)7 3396 1019
upm@unpuntomacrobiotico.com
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
UPM Un Punto Macrobiotico International Association (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We wish to publish our results as soon as possible
Intention to publish date
31/03/2016
Participant level data
Available on request
Results - basic reporting
Publication summary