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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight/Obesity, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Green coffee extract
* Dietary Supplement: Beta glucan
* Dietary Supplement: Green coffee + beta-glucan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green coffee extract<br>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<br>* 150 mg polyphenols from green coffee, twice daily<br>|
| Experimental: Beta-glucan<br>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<br>* 2.5 g BG twice daily<br>|
| Experimental: Green coffee + Beta-glucan<br>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<br>* 150 mg polyphenols from green coffee + 2.5 g BG, twice daily<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-communicable diseases, Obesity, Polyphenols, Soluble dietary fiber, Nutraceutical