Skip to main content
Clinical Trials/NCT05009615
NCT05009615CompletedNot Applicable

Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición2 sites in 1 country30 target enrollmentStarted: December 3, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Body weight

Study Overview

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.

Detailed Description

In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was followed by a 4-week wash-out.

Blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. Physical activity was controlled by accelerometry (1 week during each intervention stage). Energy expenditure was measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was determined by subjective (VAS) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage.

In a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted metabolomic analysis was carried out in these samples. In these volunteers, incretins and hormones were also determined in blood samples.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Known hypersensibility/allergy to any of the tests products
  • Pregnant women
  • On dietary regimen or physical training to lose weight

Outcomes

Primary Outcomes

Body weight

Time Frame: 8 weeks

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

Secondary Outcomes

  • Insulin resistance(8 weeks)
  • Body fat percentage(8 weeks)
  • Anthropometry(8 weeks)
  • Blood lipids(8 weeks)

Investigators

Sponsor
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Laura Bravo

Professor

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Study Sites (2)

Loading locations...

Similar Trials