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Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)

I

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Status

Completed

Conditions

Overweight and Obesity

Treatments

Dietary Supplement: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT04321590
AGL2015-69986-R_PS

Details and patient eligibility

About

Randomized, double blind, parallel study to assess the effect of a dietary supplement combining polyphenols (hydroxycinnamates from green coffee) and a soluble dietary fiber (oat beta-glucans) in obese/overweight subjects.

Full description

This pilot study intends to select the best combination of beta-glucan and a green coffee bean phenolic extract. Four different supplements were formulated, containing 3 or 5 g of two types of beta-glucan, with 35% and 70% b-glucan content, together with 600 mg of the green coffee bean extract. Blind sachets were prepared containing half the daily dose of the supplement.

60 overweight/obese male and female volunteers (BMI 25-35 kg/m2, 18-60 y old) were recruited and randomly assigned to one of the four intervention groups. Volunteers were instructed to consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily during 6 weeks.

At the beginning and at the end of the study, volunteers came to the Human Nutrition Unit at the research center after an overnight fast. Urine and blood samples were obtained, blood pressure was measured and anthropometric measurements were performed. Dietary and physical activity records were collected.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Overweight/obese subjects (BMI 25-35 kg/m2)

Exclusion criteria

  • Smokers
  • Pregnant women
  • Medication/consumption of vitamins, dietary supplements, etc.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 4 patient groups

3 g 35% beta-glucan
Experimental group
Description:
Supplement containing 3 g of 35% oat beta-glucan
Treatment:
Dietary Supplement: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)
5 g 35% beta-glucan
Experimental group
Description:
Supplement containing 5 g of 35% oat beta-glucan
Treatment:
Dietary Supplement: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)
3 g 70% beta-glucan
Experimental group
Description:
Supplement containing 3 g of 70% oat beta-glucan
Treatment:
Dietary Supplement: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)
5 g 70% beta-glucan
Experimental group
Description:
Supplement containing 5 g of 70% oat beta-glucan
Treatment:
Dietary Supplement: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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