Small frequent meals vs large infrequent meals in patients with diabetes

Small frequent meals versus large infrequent meals in Indian patients with type 2 diabetes mellitus- a randomized cross-over trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064443

Enrollment

Registered

2024-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Small frequent meals (SFM): Diet advice will be provided in accordance with the Dietary guidelines for Indians (NIN, ICMR, 2011) and ESI-RSSDI Clinical Practice Recommendations for the

Eligibility

Inclusion criteria

Inclusion criteria: 1.Type 2 diabetes mellitus diagnosed as per the WHO criteria 2.Age between 20-65 years and belonging to either sex 3.Baseline HbA1c between 8.5-11.0%

Exclusion criteria

Exclusion criteria: 1.Current treatment with insulin or insulin secretagogues 2.BMI more than 35kg/m2 3. Co-morbidities including Coronary artery disease, congestive heart failure and other edematous states, chronic kidney disease Stage III or worse, chronic liver disease, malignancy and chronic infections (such as tuberculosis), Hypo or hyperthyroidism, malignancy, mental disorders 4.History of severe hypoglycemia or recurrent hypoglycemic episodes over last 2 months 5.Gastrointestinal disorders which preclude large meal intake 6.Unstable weight (increase or decrease of more than 3 kg over last 2 months 7.Anxiety disorders 8.Chronic alcohol intake, smoking or substance abuse 9.Drugs known to increase weight including antidepressants, antipsychotics, antiepileptic drugs 10.Pregnant or lactating females 11.Shift workers

Design outcomes

Primary

Measure	Time frame
The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on Glycemic parameters Timepoint: At end of 12 weeks and 24 weeks	—

Secondary

Measure	Time frame
he effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on hormones Timepoint: At end of 12 weeks and 24 weeks;he effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on obesity Timepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on blood pressureTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on body compositionTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on hsCRPTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on lipid profileTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM)on HOMA IRTimepoint: At end of 12 weeks and 24 weeks	—

Measure

Time frame

he effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on hormones Timepoint: At end of 12 weeks and 24 weeks;he effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on obesity Timepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on blood pressureTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on body compositionTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on hsCRPTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on lipid profileTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM)on HOMA IRTimepoint: At end of 12 weeks and 24 weeks

—

Countries

India

Contacts

Public ContactSV Madhu

UCMS and GTB Hospital

drsvmadhu@gmail.com09871891018

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026