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

Not Applicable

Completed

• Conditions: Overweight/Obesity; Insulin Resistance
• Interventions: Dietary Supplement: Green coffee + beta-glucan; Dietary Supplement: Green coffee extract; Dietary Supplement: Beta glucan

• Registration Number: NCT05009615
• Lead Sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición

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 Timeline

• Study Start: 2018-12-03
• Primary Completion: 2019-12-14
• Study Completion: 2019-12-14
• Study First Submitted: 2021-07-29
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Green coffee + Beta-glucan	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
Green coffee extract	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
Beta-glucan	Beta glucan	Nutraceutical containing a oat beta-glucan. Participants received powdered sachets containing 2.5 g of BG twice daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Body weight	8 weeks	Change of body weight (estimated 2.5 kg) at the end of the intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición; 🇪🇸 Madrid, Spain