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

Insulin Resistance Clinical Trial

— OBHEALTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009615
• Other study ID #: AGL2015-69986-R
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 14, 2019

Study information

• Verified date: August 2021
• Source: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 14, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Overweight
• Overweight/Obesity

Intervention

Dietary Supplement:
• Green coffee extract
150 mg polyphenols from green coffee, twice daily
• Beta glucan
2.5 g BG twice daily
• Green coffee + beta-glucan
150 mg polyphenols from green coffee + 2.5 g BG, twice daily

Locations

Country	Name	City	State
Spain	Instituto de Ciencia y Tecnología de Alimentos y Nutrición	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Change of body weight (estimated 2.5 kg) at the end of the intervention	8 weeks
Secondary	Body fat percentage	Change of body fat percentage (total and visceral)	8 weeks
Secondary	Anthropometry	Change of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention	8 weeks
Secondary	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
Secondary	Blood lipids	Modification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention	8 weeks