High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes

ConditionPre-diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorDiabetes Foundation, India

About this trial

Diabetes/ prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Acute infections and advanced end-organ damage.

History of hepatitis or pancreatitis, abnormal liver and renal function tests.

Recent (<3 months) changes in weight (≥5%) and/or weight changing medications.

Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention

    Other intervention

    high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: High Protein DietExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Body Mass Index

BMI will be calculated by using formula weight (Kg)/height (m2).

Time frame
6 Months
2

Body Fat

Body estimations will be done by DEXA Scan

Time frame
2 MONTHS
3

Liver Fat

Liver fat will be done by MRI Scan

Time frame
2 Months
4

Next Generation sequencing

Time frame
06 MONTHS

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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