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

NCT07801378 | Not Yet Recruiting DMC

• 1 other identifier: 43019892
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabete Mellitus; Obesity & Overweight; Hypertriglyceridaemia

Keywords

low_carbohydrate diet; type 2 diabetes; T2D; Obesity; metabolic indexes; hypertriglyceridaemia

Outcome Measures

Primary Outcomes (1)

• Change in fasting serum triglyceride (TG) level

  Baseline to Week 12

Secondary Outcomes (11)

• Change in glycated hemoglobin (HbA1c)

  Baseline to Week 12

• Change in fasting blood glucose (FBS)

  Baseline to Week 12

• Change in total cholesterol

  Baseline to Week 12

• Change in LDL-C

  Baseline to Week 12

• Change in systolic blood pressure

  Baseline to Week 12

Study Arms (3)

High-Protein Low-Carbohydrate Diet

EXPERIMENTAL

Other: High-Fat Low-Carbohydrate Diet; Other: Standard diet

High-Fat Low-Carbohydrate Diet

EXPERIMENTAL

Other: High-Protein Low-Carbohydrate Diet; Other: Standard diet

Standard diet

ACTIVE COMPARATOR

Other: High-Protein Low-Carbohydrate Diet; Other: High-Fat Low-Carbohydrate Diet

Interventions

High-Fat Low-Carbohydrate Diet OTHER

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.

High-Protein Low-Carbohydrate Diet; Standard diet

Standard diet OTHER

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.

High-Fat Low-Carbohydrate Diet; High-Protein Low-Carbohydrate Diet

High-Protein Low-Carbohydrate Diet OTHER

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; Standard diet

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m\^2
• Age between 30 and 70 years
• If taking medication for diabetes, dyslipidemia, or hypertension, dose stable for at least 8 weeks prior to enrollment
• Able to follow the prescribed diet
• Willing and able to provide informed consent

You may not qualify if:

• 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/1.73m\^2
• Type 1 diabetes or rare metabolic disorders
• Severe renal, cardiac, or hepatic disease, or active pancreatitis
• Established cardiovascular disease (myocardial infarction, stroke, coronary angioplasty or bypass surgery, or heart failure)
• Pregnancy, breastfeeding, or planning pregnancy during the study
• Psychiatric disorder or social circumstances that would prevent adherence to the dietary protocol
• Change in dose or type of diabetes, lipid-lowering, or blood pressure medication within 8 weeks before enrollment or during the study
• Use of weight-loss medications, protein supplements, or probiotics
• Body weight change greater than 3% within the past 6 months
• Withdrawal of consent to continue participation

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Overweight; Hypertriglyceridemia; Diabetes Mellitus, Type 2

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet, High-Protein; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

zeynab kavyani, PhD student

CONTACT

+989330510977; zeinab.kaviani97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Participants are randomized in a 1:1:1 ratio to one of three parallel 12-week dietary arms: a moderate low-carbohydrate high-protein diet, a moderate low-carbohydrate high-fat diet, or a standard diet.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 20, 2026
• Primary Completion: September 20, 2026
• Study Completion: September 20, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09