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Comparing Two Low-Carbohydrate Diets With a Standard Diet in Type 2 Diabetes

ConditionsDiabete MellitusObesity & OverweightHypertriglyceridaemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorNational Nutrition and Food Technology Institute

About this trial

Type 2 diabetes is often accompanied by high blood triglycerides and excess weight, and diet plays a central role in managing these conditions together. The purpose of this study is to compare the effects of two moderate low-carbohydrate diets - one higher in protein and one higher in fat - against a standard diet, on blood sugar control, blood lipids (especially triglycerides), body weight, and blood pressure in adults with type 2 diabetes, hypertriglyceridemia, and overweight or obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with type 2 diabetes mellitus for at least 6 months

Fasting serum triglycerides between 200-399 mg/dL

Body mass index (BMI) between 25 and 35 kg/m²

Age between 30 and 70 years

Disqualifiers

Fasting triglycerides of 400 mg/dL or higher, or lower than 200 mg/dL

HbA1c greater than 10.5%

eGFR less than 30 mL/min/1.73m²

Type 1 diabetes or rare metabolic disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Protein Low-Carbohydrate Diet

    Other intervention

    A calorie-restricted (500 kcal/day below baseline needs) diet providing 40% of energy from complex carbohydrates, 30% from fat (20% unsaturated with a 4:1 MUFA/PUFA ratio, 10% saturated), and 30% from protein (15% plant-based), delivered over 12 weeks as 5 individualized daily meals.

  • High-Fat Low-Carbohydrate Diet

    Other intervention

    A calorie-restricted (500 kcal/day below baseline needs) diet providing 40% of energy from complex carbohydrates, 45% from fat (35% unsaturated with a 4:1 MUFA/PUFA ratio, 10% saturated), and 15% from protein, delivered over 12 weeks as 5 individualized daily meals.

  • Standard diet

    Other intervention

    A calorie-restricted (500 kcal/day below baseline needs) standard diet providing 55% of energy from complex carbohydrates, 30% from fat (20% unsaturated with a 4:1 MUFA/PUFA ratio, 10% saturated), and 15% from protein, delivered over 12 weeks as 5 individualized daily meals.

Treatment groups

168 Participants
are divided into 3 treatment groups
Group A: High-Protein Low-Carbohydrate DietExperimental treatment 2 interventions
Group B: High-Fat Low-Carbohydrate DietExperimental treatment 2 interventions
Group C: Standard dietActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in fasting serum triglyceride (TG) level

Time frame
Baseline to Week 12

Secondary outcomes

1

Change in glycated hemoglobin (HbA1c)

Time frame
Baseline to Week 12
2

Change in fasting blood glucose (FBS)

Time frame
Baseline to Week 12
3

Change in total cholesterol

Time frame
Baseline to Week 12
4

Change in LDL-C

Time frame
Baseline to Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Nutrition and Food Technology Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: