Sonova GLA safflower oil (840 mg GLA per day)

Weight Trajectory

gamma-linolenic acid

3 capsules per day of placebo for 24 months

placebo

Virta Health

Gamma-linolenic Acid Supplementation Study

Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment

Body weight measured on a calibrated scale. Interim analyses at 12 and 18 months; if greater weight loss is maintained in the GLA compared to placebo group, the study will be unblinded and placebo group participants will cross over to GLA for the remainder of the trial.

Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months

Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months

Eating Loss of Control Scale (ELOCS) administered every 6 months

Body Image States Scale (BISS) administered every 6 months

Prescribed medications obtained from medical record

Identifiers will be removed and data could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.

Participants will be randomized 3:1, GLA:placebo. Interim analyses of the primary outcome will be performed at 12 and 18 months; if greater weight loss is maintained in the GLA compared to placebo group, the study will be unblinded and placebo group participants will cross over to the GLA group for the remainder of the trial.

The patients of this group were randomized to receive an energy-restricted diet (20 kcal/kg/ideal body weight/day) enriched of n-3 PUFAs (average 2.6 g/d).

The participants of this group are randomized to receive drug therapy alone, continuing their usual diet

Plaque-type Psoriasis

Obesity (Body Mass Index >30 kg/m2)

The active diet aimed to reduce body weight, to enhance the total intake of n-3 PUFA and to decrease the total intake of n-6 PUFAs. The diet plan was designed to supply an energy intake of 20 kcal/kg/day to maintain an ideal body weight, and followed the guidelines of the American Heart Association (AHA) 'Step-One' Diet: Carbohydrates (mainly complex carbohydrates) and protein constituted of 50-60% and 10-20% of total calories, respectively, and total fat did not exceed 30% of calories. Food values for energy and nutrients were taken from the tables of the Italian National Institute of Nutrition, Souci's Food Composition and Nutrition Tables and the European Institute of Oncology. For long-term and practical daily eating habits, it was important to easily incorporate and consume a variety of selected foods.

Energy-restricted, n-3 polysaturated fatty acids-rich diet

The patients of this group were randomized to continue their usual diet

Usual diet

federico II University

n-3 Polysaturated Fatty Acids-rich Diet in Psoriasis

Energy-restricted, n-3 Polysaturated Fatty Acids-rich Diet Improves the Clinical Response to Immuno-modulating Drugs in Obese Patients With Plaque-type Psoriasis: a Randomized Control Clinical Trial.

Fasting blood samples were drawn for the following measurements: serum total cholesterol, HDL-cholesterol (HDL-C), LDL-C, triglycerides, fibrinogen and serum glucose. Serum LDL-C concentration was calculated using the Friedewald equation.

BMI was calculated as the ratio of body weight to height2 (kg/m2). Waist circumference was measured with an inelastic tape, the subject in standing position, at the level of the umbilicus. According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) criteria,abdominal obesity was defined as waist circumference ≥102 cm in men and ≥88 cm in women

Clinical assessment was based on three separate instruments: Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and VAS for subjective itch ratings.
The PASI is used for measuring psoriasis severity. The scale evaluates four areas of the body (head/neck, upper limbs, trunk, and lower limbs) for erythema, scaliness and thickness of psoriatic plaques. The PASI score can range from 0 to 72, with higher scores indicating greater severity.
The DLQI is a self-rated instrument consisting of ten items related to the ways that skin disease may impact a patient's health-related quality of life (HRQL). Scores are based on six subscales and has a possible range 0 to 30, with 30 corresponding to the worst HRQL.
Subjective itch ratings were recorded using a computerized VAS, anchored by the terms "no itching" (0 points) and "severe itching" (10 points). Subjects were asked to respond in terms of their itching "at the present time".

Dietary compliance was evaluated by experienced dietitians trained for this project, using a combination of food diaries, personal interviews and a detailed food-frequency questionnaire that included 130 foods and beverages. Information on diet included weekly frequency of consumption and portion size. Average daily intakes were calculated by using food tables and industry estimates of the n-3 naturally-rich margarine. Total dietary n3 PUFAs refers to the intake of ALA in addition to of long-chain EPA and DHA.

gamma linolenic acid/obesity

Gamma-linolenic Acid Supplementation Study

n-3 Polysaturated Fatty Acids-rich Diet in Psoriasis

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