Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/02/2016
Date assigned
05/02/2016
Last edited
29/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes