POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes (POLYPHEM)

German Institute of Human Nutrition

Status: Unknown

Conditions: Hypertension; Obesity; Dyslipidemia; NAFLD; Type 2 Diabetes; Metabolic Syndrome

Treatments: Dietary Supplement: diet with/without supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03047668

POLYPHEM

Details and patient eligibility

About

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).

POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.

Full description

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).

POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female subjects
• 18-79 years old
• type 2 diabetes

Exclusion criteria

• renal insufficiency
• anaemia
• immunosuppression
• previous symptomatic cancer diagnosis
• acute cardiovascular disease (stroke, coronary syndrome)
• pregnancy and lactation
• severe psychiatric disorders
• corticoid or other immunosuppressive therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

low-carb with PUFA

Active Comparator group

Description:

49 weeks of hypo- to isocaloric low-carb diet (\< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins

Treatment:

Dietary Supplement: diet with/without supplementation

low-carb without PUFA

Active Comparator group

Description:

49 weeks of hypo- to isocaloric low-carb diet (\< 40 EI% carbs), without walnuts / walnut-sunflower muffins

Treatment:

Dietary Supplement: diet with/without supplementation

low-fat with PUFA

Active Comparator group

Description:

49 weeks of hypo- to isocaloric low-fat diet (\< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins

Treatment:

Dietary Supplement: diet with/without supplementation

low-fat without PUFA

Active Comparator group

Description:

49 weeks of hypo- to isocaloric low-fat diet (\< 30 EI% fat), without walnuts / walnut-sunflower muffins

Treatment:

Dietary Supplement: diet with/without supplementation