Enriched Canned Tuna With Fibre or Polyphenols on Satiety (SACIATUN)

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Overweight

Treatments: Other: Control Canned Tuna; Other: Enriched Canned Tuna Variety 1; Other: Enriched Canned Tuna Variety 2

Study type: Interventional

Funder types: Other

Identifiers

NCT03921580

5048

Details and patient eligibility

About

The purpose of this study is to evaluate the satiating effects of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects (BMI ≥25 and <30 kg / m2).

Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk.

Full description

A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects.

The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI ≥25 and <30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women from 18 to 65 years old.
• Body Mass Index (BMI) ≥25 and <30 kg/m2.
• Adequate cultural level and understanding for the clinical trial.
• Signed informed consent

Exclusion criteria

• Subjects with BMI ≥30 or <25 kg /m2
• Subjects diagnosed with Diabetes Mellitus.
• Subjects with dyslipidemia on pharmacological treatment
• Subjects with hypertension on pharmacological treatment
• Subjects with established diagnosis of eating disorder
• Smokers or those subjects with high alcohol consumption (> 2-3 servings/ day in men and> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer)
• Subjects under pharmacological treatment (except oral contraceptives)
• Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
• Subjects with sensory problems
• Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
• Pregnant or breastfeeding women
• Women with menstrual irregularities (absence of menstrual cycle at least 2 months)
• Subjects with intense physical activity.
• Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
• Subjects with a diagnosis of celiac disease or a gluten intolerance

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups, including a placebo group

Control Canned Tuna

Placebo Comparator group

Description:

Control Canned Tuna

Treatment:

Other: Control Canned Tuna

Enriched Canned Tuna Variety 1

Experimental group

Description:

Enriched Canned Tuna Variety 1: Wakame fiber

Treatment:

Other: Enriched Canned Tuna Variety 1

Enriched Canned Tuna Variety 2

Experimental group

Description:

Enriched Canned Tuna Variety 2: Polyphenols

Treatment:

Other: Enriched Canned Tuna Variety 2