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To study the role of diet and exercise on the intestine health, blood sugar levels and quality of life among Indians with prediabetes and type 2 diabetes

An exercise and nutrition supplementation program targeting muscle and gut function as a way to maintain metabolic health and quality of life among Indian adults with prediabetes and diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045096
Enrollment
108
Registered
2022-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Exercise with nutrition (prebiotic, probiotic and protein) arm: Exercise with protein and synbiotic (combination of prebiotic and probiotic) supplement for 12 weeks Intervention2: Exerc

Sponsors

St Johns Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 40-70 years Both male and female BMI 18.5-30 kg/m2 HbA1c = 5.7% or FBS = 100 mg/dl or PPBS = 140 mg/dl Diabetes within 5 years of diagnosis

Exclusion criteria

Exclusion criteria: Type 1 diabetes or type 2 diabetes with complications (diabetic foot, frequent hypoglycemic episodes) Current or prior history of inflammatory bowel disease, bariatric surgery, irritable bowel syndrome or any other malabsorption disorder    Current history of cancer or in remission for History of active cardiovascular disease with surgical intervention, hepatic or renal insufficiency, severe anemia or tuberculosis.   Current or recent antibiotic or corticosteroid use ( Current use of probiotic or prebiotic or protein supplementation   Known allergy or intolerance to probiotic or prebiotic or protein   Any neuropathy or neuromuscular disorder affecting movement Any form of recent joint injuries (knee and wrist) History of severe form of osteoarthritis affecting movement

Design outcomes

Primary

MeasureTime frame
Glycemic status and quality of lifeTimepoint: At baseline and at 12 weeks

Secondary

MeasureTime frame
Physical function (muscle strength, muscle endurance, body composition, and exercise capacity) and mental well-being (stress, anxiety, depression and cognitive function)Timepoint: At baseline and at 12 weeks;Gut bacterial composition, gut function marker and inflammatory markersTimepoint: At baseline and at 12 weeks

Countries

India

Contacts

Public ContactSHINJINI BHATTACHARYA

St Johns Medical College

sucharita@stjohns.in08049466591

Outcome results

None listed

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