Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)

NCT05009615 | Completed

• 1 other identifier: AGL2015-69986-R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.

Conditions

Overweight/Obesity; Insulin Resistance

Keywords

Obesity; Non-communicable diseases; Polyphenols; Soluble dietary fiber; Nutraceutical

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change of body weight (estimated 2.5 kg) at the end of the intervention

  8 weeks

Secondary Outcomes (4)

• Body fat percentage

  8 weeks

• Anthropometry

  8 weeks

• Insulin resistance

  8 weeks

• Blood lipids

  8 weeks

Study Arms (3)

Green coffee extract

EXPERIMENTAL

Nutraceutical containing a decaffeinated green coffee extract rich in phenolic compounds (hydroxycinnamates). Participants received powdered sachets containing 300 mg of GC extract twice daily for 8 weeks

Dietary Supplement: Green coffee extract

Beta-glucan

EXPERIMENTAL

Nutraceutical containing a oat beta-glucan. Participants received powdered sachets containing 2.5 g of BG twice daily for 8 weeks

Dietary Supplement: Beta glucan

Green coffee + Beta-glucan

EXPERIMENTAL

Nutraceutical containing both green coffee extract and beta-glucan. Participants received powdered sachets containing 2.5 g of BG plus 300 mg of GC extract twice daily for 8 weeks

Dietary Supplement: Green coffee + beta-glucan

Interventions

Green coffee extract DIETARY_SUPPLEMENT

150 mg polyphenols from green coffee, twice daily

Green coffee extract

Beta glucan DIETARY_SUPPLEMENT

2.5 g BG twice daily

Beta-glucan

Green coffee + beta-glucan DIETARY_SUPPLEMENT

150 mg polyphenols from green coffee + 2.5 g BG, twice daily

Green coffee + Beta-glucan

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, with BMI between 25-35 kg/m2
• Fasting blood glucose between 6,11-6,94 mmol/L (110-125 mg/dL) and/or
• Blood glucose between 7,77-11,04 mmol/L (140-199 mg/dL) 2 h after an oral glucose overload

You may not qualify if:

• Having other chronic pathologies different from overweight/obesity and prediabetes.
• On prescription drugs, hormones or dietary supplements (e.g. dietary fibre, pollen, vitamin complexes, etc.)
• Vegetarian
• Smoking
• Known hypersensibility/allergy to any of the tests products
• Pregnant women
• On dietary regimen or physical training to lose weight

Sponsors & Collaborators

• Instituto de Ciencia y Tecnología de Alimentos y Nutrición: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance; Noncommunicable Diseases

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Officials

• Laura Bravo, Prof

  ICTAN-CSIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Nutraceutical was provided in aluminum foil sachets marked A, B or C for blinding to participants. Aroma and flavor compounds were added to ensure similar organoleptic properties of the 3 nutraceuticals tested.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After a run-in period, participants were randomly allocated to one of each arm. Each intervention stage (8 weeks) was separated by a 4-week wash-out.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 17, 2021
• Study Start: December 3, 2018
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)