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| Name | Class |
|---|---|
| Ministerio de EconomÃa y Competitividad, Spain | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Beta-glucan | Experimental | Nutraceutical containing a oat beta-glucan. Participants received powdered sachets containing 2.5 g of BG twice daily for 8 weeks |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green coffee extract | Dietary Supplement | 150 mg polyphenols from green coffee, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Change of body weight (estimated 2.5 kg) at the end of the intervention | 8 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Bravo, Prof | ICTAN-CSIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ciencia y TecnologÃa de Alimentos y Nutrición | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D000073296 | Noncommunicable Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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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.
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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.
| Beta glucan | Dietary Supplement | 2.5 g BG twice daily |
|
| Green coffee + beta-glucan | Dietary Supplement | 150 mg polyphenols from green coffee + 2.5 g BG, twice daily |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |