Overweight and ObesitySACIMIELNCT04153617
Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia
A study testing Modified honey with soluble fiber and polyphenols in people with Overweight and Obesity and Dyslipidemias, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in subjects with overweight/obesity (BMI ≥25 y <40 kg / m2) and dyslipemia after consumption of a modifed honey with soluble fiber and polyphenols. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Dyslipidemias
- What is being tested?
- Modified honey with soluble fiber and polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jan 2019to 3 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women from 18 to 65 years old.
- Body Mass Index (BMI) ≥25 and <40 kg/m2.
- Cardiovascular risk <10% to 10 years measured by REGICOR.
- Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:
- ≥ 45 years or women ≥ 55 years.
- Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
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- HDL cholesterol: men <40 or women <50.
- Triglycerides ≥ 150mg/dL and <200 mg/dL
- LDL cholesterol ≥ 130mg/dL and < 160mg/dL
- Smoker
- Willingness to follow a healthy and balanced hypocaloric diet with mandatory physical activity
- Social or familiar environment that prevents from accomplishing the dietary treatment
- Adequate cultural level and understanding for the clinical trial.
- Signed informed consent
Who cannot join
- Body Mass Index (BMI) <25 and ≥40 kg/m2.
- Individuals diagnosed with Diabetes Mellitus type 1 or 2.
- Individuals with dyslipidemia on pharmacological treatment.
- Individuals with hypertension on pharmacological treatment.
- Individuals diagnosed with eating disorders.
- Individuals fructose-intolerant.
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- Individuals with a diagnosis of celiac disease or a gluten intolerance.
- Individuals with severe chronic diseases (hepatic, kidney, …)
- Individuals receiving a pharmacological treatment that modifies the lipid or glucose profile.
- Individuals who have participated in the last 3 months in a program or clinical trial to lose weight.
- Individuals with mental illness.
- Smokers wanting to stop to smoke during the period that clinical trial lasts.
- Individuals with high alcohol consumption (> 2-3 servings/ day in men and> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer).
- Individuals with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet.
- Individuals with sensory problems.
- Individuals with gastrointestinal diseases that affect the digestion or absorption of nutrients.
- Individuals under pharmacological treatment for losing weight unless treatment is suspended 30 days before the start of the trial.
- Subjects with intense physical activity.
- Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional and Clinical Trial to Evaluate the Effect of a Modified Honey With Soluble Fiber and Polyphenols Consumption in Subjects With Overweight/Obesity and Dyslipidemia
The aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in subjects with overweight/obesity (BMI ≥25 y <40 kg / m2) and dyslipemia after consumption of a modifed honey with soluble fiber and polyphenols.
Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. Besides, polyphenols have reported with their potent antioxidant effect and their implication lowering the vardiovascular risk.
Read the detailed description
The trial was designed as a randomized, parallel, double-blind and controlled study with 2 experimental arms. This study was performed to evaluate the effect on saciety and dyslipidemia of subjects with overweight/obesity after a long consumption (3 months) of a modified honey with soluble fiber and polyphenols. Additionally, a short-term randomized, cross-over, doble-blind and controlled trial was also performed to evaluate immediate saciety effect on the same subjects.
For the middle-term study, investigators included 67 participants (8 men and 59 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants received the 2 different study products during the 3 months. On the other hand, the associated short-term trial included 10 participants (5 men and 5 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants took the 2 different study products in two non-consecutive days.
- Conditions
- Overweight and Obesity, Dyslipidemias
- Being tested
- Control honey, Modified honey with soluble fiber and polyphenols
- Keywords
- Saciety, Honey, Fiber, Polyphenols, Visual Analogue Scale, Cross-over, Parallel
- Medical subject headings
- Overweight, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control honeyDietary supplement
Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day)
Modified honey with soluble fiber and polyphenolsDietary supplement
Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)
| Study group | Role | What they receive |
|---|---|---|
| Control honey | Placebo comparator | Orange blossom honey.
Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day.
Short term trial: 20g/day in a single day. Receives: Dietary Supplement: Control honey; Dietary Supplement: Modified honey with soluble fiber and polyphenols |
| Modified honey with soluble fiber and polyphenols | Experimental | Honey modified with soluble fiber and polyphenols
Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day.
Short term trial: 20g/day in a single day. Receives: Dietary Supplement: Control honey; Dietary Supplement: Modified honey with soluble fiber and polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Satiety Hunger Assessment
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line.
e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.
Measured: Day 1, 2
Secondary outcomes (7)
Change from Baseline Lipid Metabolism Parameters
Cholesterol, LDL-C, HDL-C, TG
Measured: Week 1,12
Amount of food consumed in a "food ad libitum"
120 min After eating the study product
Measured: Day 1, 2
Total amount of food consumed in 24h
24h Food Record Method
Measured: Day 1, 2; Week 1, 6, 12
Change from Baseline Glucose Metabolism Parameters
Glucose
Measured: Day 1, 2; Week 1, 12
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
Measured: Day 1, 2; Week 1, 12
Sensory Perception Test
Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.
Measured: Day 1, 2; Week 6, 12
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Measured: Day 1, 2; Week 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start14 Jan 2019
- Primary completion19 Apr 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Primo Mendoza S.L.
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, MD, Phd, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153617
- Sponsor's protocol ID
- HULP 5049
- Acronym
- SACIMIEL
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Clinical Trial to Evaluate the Effect of a Modified Honey With Soluble Fiber and Polyphenols Consumption in Subjects With Overweight/Obesity and Dyslipidemia
- ClinicalTrials.gov ID
- NCT04153617
- Acronym / sponsor ID
- SACIMIEL / HULP 5049
- Conditions
- Overweight and Obesity, Dyslipidemias
- Keywords
- Saciety, Honey, Fiber, Polyphenols, Visual Analogue Scale, Cross-over, Parallel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Primo Mendoza S.L.
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in subjects with overweight/obesity (BMI ≥25 y <40 kg / m2) and dyslipemia after consumption of a modifed honey with soluble fiber and polyphenols.
Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. Besides, polyphenols have reported with their potent antioxidant effect and their implication lowering the vardiovascular risk.
Detailed description
The trial was designed as a randomized, parallel, double-blind and controlled study with 2 experimental arms. This study was performed to evaluate the effect on saciety and dyslipidemia of subjects with overweight/obesity after a long consumption (3 months) of a modified honey with soluble fiber and polyphenols. Additionally, a short-term randomized, cross-over, doble-blind and controlled trial was also performed to evaluate immediate saciety effect on the same subjects.
For the middle-term study, investigators included 67 participants (8 men and 59 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants received the 2 different study products during the 3 months. On the other hand, the associated short-term trial included 10 participants (5 men and 5 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants took the 2 different study products in two non-consecutive days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control honey | Placebo comparator | Dietary Supplement: Control honey, Dietary Supplement: Modified honey with soluble fiber and polyphenolsOrange blossom honey. Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day. Short term trial: 20g/day in a single day. |
| Modified honey with soluble fiber and polyphenols | Experimental | Dietary Supplement: Control honey, Dietary Supplement: Modified honey with soluble fiber and polyphenolsHoney modified with soluble fiber and polyphenols Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day. Short term trial: 20g/day in a single day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women from 18 to 65 years old.
- Body Mass Index (BMI) ≥25 and <40 kg/m2.
- Cardiovascular risk <10% to 10 years measured by REGICOR.
- Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:
- Willingness to follow a healthy and balanced hypocaloric diet with mandatory physical activity
Key exclusion criteria (20 listed)
- Body Mass Index (BMI) <25 and ≥40 kg/m2.
- Individuals diagnosed with Diabetes Mellitus type 1 or 2.
- Individuals with dyslipidemia on pharmacological treatment.
- Individuals with hypertension on pharmacological treatment.
- Individuals diagnosed with eating disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control honeyControl honey defined as orange blossom honey. Intake daily for 3 months (40 g/day) | Dietary supplement | Control honey, Modified honey with soluble fiber and polyphenols |
| Modified honey with soluble fiber and polyphenolsHoney modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day) | Dietary supplement | Control honey, Modified honey with soluble fiber and polyphenols |
Primary outcome
Change from Baseline Satiety Hunger Assessment
Time frame: Day 1, 2
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line. e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.
7 secondary outcomes
Change from Baseline Lipid Metabolism Parameters
Time frame: Week 1,12
Amount of food consumed in a "food ad libitum"
Time frame: Day 1, 2
Total amount of food consumed in 24h
Time frame: Day 1, 2; Week 1, 6, 12
Change from Baseline Glucose Metabolism Parameters
Time frame: Day 1, 2; Week 1, 12
Anthropometric Parameters
Time frame: Day 1, 2; Week 1, 12
Sensory Perception Test
Time frame: Day 1, 2; Week 6, 12
Adverse Effects
Time frame: Day 1, 2; Week 6, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, MD, Phd principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified honey with soluble fiber and polyphenols in people with Overweight and Obesity and Dyslipidemias, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Satiety Hunger Assessment (time frame: Day 1, 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.