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

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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Overweight/Obesity
• Intervention / Treatment: Dietary supplement: Green coffee extract; Dietary supplement: Beta glucan; Dietary supplement: Green coffee + beta-glucan

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Green coffee extract; 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; 150 mg polyphenols from green coffee, twice daily
EXPERIMENTAL: Beta-glucan; 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; 2.5 g BG twice daily
EXPERIMENTAL: Green coffee + Beta-glucan; 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; 150 mg polyphenols from green coffee + 2.5 g BG, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Change of body weight (estimated 2.5 kg) at the end of the intervention	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat percentage	Change of body fat percentage (total and visceral)	8 weeks
Anthropometry	Change of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention	8 weeks
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	8 weeks
Blood lipids	Modification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention	8 weeks

Collaborators and Investigators

• Sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
• Collaborators: Ministerio de Economía y Competitividad, Spain
• Investigators: Principal Investigator: Laura Bravo, Prof, ICTAN-CSIC

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2018
• Primary Completion (ACTUAL): December 14, 2019
• Study Completion (ACTUAL): December 14, 2019

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (ACTUAL): August 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Nutraceutical; Polyphenols; Non-communicable diseases; Soluble dietary fiber
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Hyperinsulinism; Obesity; Insulin Resistance; Overweight
• Other Study ID Numbers: AGL2015-69986-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No