Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04917991
Other study ID # CHOCO study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2019
Est. completion date December 20, 2019

Study information

Verified date June 2021
Source Campus Bio-Medico University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial aims to investigate if extra virgin olive oil (EVOO) or palm oil enriched chocolate spread snacks consumption lead to differential insulin resistance status in young, healthy subjects. Such effect includes difference in a) plasma ceramides, b) glucose metabolism markers, c) lipid profile, d) inflammatory markers, e) hunger/satiety hormonal markers and visual analogue scale.


Description:

Exceeding intake of foods high in palmitic acid, abundant in Palm Oil, has been associated with lipotoxicity, a condition featured by high toxic lipids in the body such as ceramides, which ultimately can lead to insulin resistance and therefore to diabetes and increased cardiometabolic risk through the promotion of atheroma plaque formation. On the other hand, foods high in oleic acid, rich in extra virgin olive oil EVOO and typical of the Mediterranean diet, has been related to reduced insulin resistance and inflammatory state, with proved protective effects against metabolic diseases such as diabetes, hypercholesterolemia and cardiovascular disease. Therefore, this clinical trial aims to assess potential metabolic differences in relation to daily consumption of EVOO-enriched chocolate spread in comparison with a Palm oil-enriched chocolate spread. The investigators, therefore, aimed to evaluate the impact of fourteen days consuming the two different oils added to the same chocolate spread in terms of the composition of plasma ceramides as the primary outcome; and as secondary outcomes, changes in glucose metabolism markers (Glucose, Insulin, HOMA-IR), in LDL, total cholesterol, Triglycerides, HDL levels, in inflammation Markers (CRP, IL-6, TNF-a) and in the appetite-regulating hormones (Leptin, Adiponectin, GLP-1, Ghrelin, PYY and Oxyntomodulin) and in the visual analogue scale (VAS) analysis. Both chocolate spreads have an identical composition with the exception of fat content (EVOO vs. Palm Oil). Once eligibility will be assessed through screening and medical anamnesis, twenty healthy subjects will be enrolled and randomized based on a double-blind, controlled, crossover design. They will undergo a 1-week "run-in diet" phase before the randomization (V1) and the inception of a 14-day interventional diet phase 1. A compliance visit (V2) will be performed on day-7 to ensure that daily compliance is available from each participant (i.e., that the chocolate spread provided is eaten daily). On day 14, the participants will undergo a meal Challenge (V3), consuming the chocolate spread jar (challenge meal) and, serial blood withdrawals will be performed at times 0 ', 30', 60 ', 90', 120 'and 180 ' and, at the same time points, subjects will be required to complete a Visual Analogue Scale (VAS) for monitoring hunger and satiety. Subsequently, the subjects will undergo another week of run-in diet, identical to the previous run-in diet, to be then allocated to another fourteen days of the opposite treatment to the previous one, with the same described methods. Also, in all the visits physical examination with the collection of anthropometric data and body composition analysis will be performed. Study subjects will be provided structured meals, according to isocaloric diets designed by nutritionists based on subjects' energy requirements. Meals will be prepared by specific canteens and consumed on-site or collected daily in individual meal boxes. Patients will be asked to fill daily food diaries, in order to ensure all of the daily food is ingested (including the chocolate spread), as well as to assess any leftovers.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 20, 2019
Est. primary completion date December 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthy volunteers of both genders. - Aged > 18 years. - Body mass index ranging from 18 to 29.99 kg/m2. - Subjects able to provide written informed consent. Exclusion Criteria: - Diagnosis of diabetes. defined as per the Italian Society of Diabetology guidelines. fasting glucose twice greater than 126 mg / dL and/or random glucose greater than 200 mg / dL. - Subjects being treated with oral and/or injectable hypoglycemic and/or insulin-sensitizing agents - Subjects undergoing therapy with synthetic cholesterol-lowering agents (statins and/or fibrates) and/or cholesterol-lowering nutraceuticals (berberine and/or monacolin k) - Individuals with triglycerides greater than 200 mg/dL - Subjects with LDL greater than 159 mg/dL - Moderate or major renal impairment (and GFR <60 mL/min) - Hypertensive subjects and/or subjects being treated with antihypertensives - Subjects receiving omega 3 supplements. - Pregnancy and/or breastfeeding. - Coronary cardiovascular disease. - Stroke and heart failure. - Celiac disease. - Malabsorption. - Irritable bowel syndrome. - Chronic inflammatory bowel disease. - Present alcoholism or drug abuse or use of medicines whose dose may change during the study or when there is an intention to start a new therapy. - Individuals with an allergy to hazelnuts or any of the ingredients present in the chocolates under study. - Neurological or psychiatric pathologies - Subjects who cannot participate in the study for any reason - Infectious diseases such as HIV, hepatitis or chronic infections - Any uncontrolled endocrine pathology such as Cushing's. Acromegaly. etc. - Any existing cancer and/or lymphoma - Eating disorders such as anorexia and bulimia - Previous bariatric surgery or gastrectomy - Individuals with pacemakers - Not consuming the chocolate spread for more than three days

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Extra Virgin Olive Oil-enriched chocolate spread
the intervention consists in the administration of 100g Extra Virgin Olive Oil-enriched chocolate spread each day for 14 days.
Palm Oil-enriched chocolate spread
the intervention consists in the administration of 100g Palm Oil-enriched chocolate spread each day for 14 days.

Locations

Country Name City State
Italy Campus Bio-Medico University of Rome Rome Lazio

Sponsors (1)

Lead Sponsor Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Ceramides Fasting Ceramides expressed in nmol At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) HOMA-IR calculated as ((fasting insulin (mU/mL) x fasting glucose (mg/dL))/405) At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Insulin Fasting Plasma Insulin reported in mU/mL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Glucose Fasting Plasma glucose reported in mg/dL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Low Density Lipoprotein (LDL) Fasting LDL reported in mg/dL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Triglycerides Fasting Triglycerides reported in mg/dL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Total Cholesterol Fasting Total Cholesterol reported in mg/dL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma High Density Lipoprotein (HDL) Fasting Plasma HDL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma C-reactive protein (CRP) Fasting CRP reported in mg/dL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Interleukin-6 Fasting interleukin-6 reported in pg/mL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Tumor Necrosis Factor-alpha (TNF-alpha) Fasting TNF-alpha reported in pg/mL At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Glucagon Like Peptide-1 (GLP-1) GLP-1 Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min. At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Oxyntomodulin Oxyntomodulin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min. At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Ghrelin Ghrelin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min. At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Peptide YY (PYY) PYY Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min. At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Leptin Leptin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min. At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Plasma Adiponectin Adiponectin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min. At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Secondary Visual Analogue Scale (VAS) VAS Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in mm*min. At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
See also
  Status Clinical Trial Phase
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Not yet recruiting NCT05218980 - Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health N/A
Not yet recruiting NCT04119791 - A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice N/A
Recruiting NCT05660837 - Online Social Support Program for Physical and Mental Health of Filipino Migrant Domestic Workers in Hong Kong N/A
Completed NCT05098223 - Price Promotions on Purchases of Snacks N/A
Active, not recruiting NCT05400187 - Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management N/A
Completed NCT03941392 - Nutritional Study in Spanish Pediatric Population
Completed NCT03378843 - Spermidine Intake and All-cause Mortality N/A
Completed NCT04596254 - Detection of Gut Metabolites in Mother's Milk Following Juice Intake N/A
Completed NCT04078646 - Influence of Proteins on the Bioavailability of Carotenoids N/A
Completed NCT05351853 - Metabolic Effects of Plant-based Diet N/A
Completed NCT04275843 - The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults N/A
Completed NCT05619276 - Acute Intervention to Assess the Impact of Practical Strategies for Healthy Eating N/A
Recruiting NCT05290064 - Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism N/A
Completed NCT06119165 - Impact of Environmental Nudges on Dietary Quality N/A
Completed NCT03967912 - MOVE UP Lifestyle Intervention for Caregivers N/A
Recruiting NCT05657730 - Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults N/A
Completed NCT05213273 - Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population N/A
Active, not recruiting NCT04329962 - Metabolism and Absorption of Anthocyanins From Extract and Whole Blueberry Powder Confections in Healthy Adults N/A
Recruiting NCT04299685 - Family Factors of Eating Habits Among Adolescents