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

Primary Purpose

Overweight/Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Green coffee extract
Beta glucan
Green coffee + beta-glucan
Sponsored by
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight/Obesity focused on measuring Obesity, Non-communicable diseases, Polyphenols, Soluble dietary fiber, Nutraceutical

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Green coffee extract

Beta-glucan

Green coffee + Beta-glucan

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body fat percentage
Change of body fat percentage (total and visceral)
Anthropometry
Change of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention
Insulin resistance
Change in fasting blood glucose and/or insulin levels, use to calculate homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR), beta-cell function (HOMA-beta) or quantitative insulin sensitivity check index (QUICKI) indexes. Outcome would be a modification of at least one of these indexes at the end of the intervention
Blood lipids
Modification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention

Full Information

First Posted
July 29, 2021
Last Updated
August 11, 2021
Sponsor
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05009615
Brief Title
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)
Acronym
OBHEALTH
Official Title
Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
December 14, 2019 (Actual)
Study Completion Date
December 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight/Obesity, Insulin Resistance
Keywords
Obesity, Non-communicable diseases, Polyphenols, Soluble dietary fiber, Nutraceutical

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green coffee extract
Arm Type
Experimental
Arm Description
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
Arm Title
Beta-glucan
Arm Type
Experimental
Arm Description
Nutraceutical containing a oat beta-glucan. Participants received powdered sachets containing 2.5 g of BG twice daily for 8 weeks
Arm Title
Green coffee + Beta-glucan
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Green coffee extract
Intervention Description
150 mg polyphenols from green coffee, twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta glucan
Intervention Description
2.5 g BG twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Green coffee + beta-glucan
Intervention Description
150 mg polyphenols from green coffee + 2.5 g BG, twice daily
Primary Outcome Measure Information:
Title
Body weight
Description
Change of body weight (estimated 2.5 kg) at the end of the intervention
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Body fat percentage
Description
Change of body fat percentage (total and visceral)
Time Frame
8 weeks
Title
Anthropometry
Description
Change of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention
Time Frame
8 weeks
Title
Insulin resistance
Description
Change in fasting blood glucose and/or insulin levels, use to calculate homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR), beta-cell function (HOMA-beta) or quantitative insulin sensitivity check index (QUICKI) indexes. Outcome would be a modification of at least one of these indexes at the end of the intervention
Time Frame
8 weeks
Title
Blood lipids
Description
Modification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Smoking Known hypersensibility/allergy to any of the tests products Pregnant women On dietary regimen or physical training to lose weight
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Bravo, Prof
Organizational Affiliation
ICTAN-CSIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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