Oxidative StressNCT06769035
Effect of a Food Supplement with Natural Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients
A study testing Cocoa, amaranth seed and ginger, Amaranth seed and Cocoa in people with Oxidative Stress and Inflammation Biomarkers, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Clinical trial, randomized, double-blind, controlled with a placebo group, 40 patients between 18 and 60 years of age, with the presence of overweight, will be divided into parallel groups, group A cocoa, amaranth seed and ginger, group B cocoa, group C amaranth, group D placebo, with the objective of evaluating the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Oxidative Stress, Inflammation Biomarkers, Obesity and Overweight
- What is being tested?
- Cocoa, amaranth seed and ginger, Amaranth seed and Cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 20 Aug 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent;
- Men or women;
- Age between 18 and 60 years;
- Waist circumference ≥ 88 cm in women or ≥ 94 cm in men;
- Plus one of the following criteria:
- BMI >25 kg/m2 and not > 30 kg/m2 in both genders or history of bariatric surgery > 6 months;
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- Fasting serum glucose of 100-125 mg/dL or HbA1c of 5.7-6.4% or on pharmacological treatment with OAD for prediabetes;
- Insulin resistance by HOMA > 2.6 and insulin sensitivity by QUICKI <0.34;F.
- Negative pregnancy test.
Who cannot join
- On pharmacological treatment or diet for weight control;
- Routine use of antioxidants in the last 3 months;
- BMI ≥ 30 kg/m2 or recent bariatric surgery (< 6 months);
- LDL cholesterol > 160 mg/dL or total cholesterol > 200 mg/dL, and no treatment for dyslipidemia;
- Major micro or macrovascular complications due to severe metabolic disease (history of acute coronary syndrome, cerebrovascular disease, peripheral arterial insufficiency or aortic aneurysm);
- Pregnancy or breastfeeding;
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- Refusal to use an effective contraceptive method for the duration of the study;
- Hypersensitivity to any of the components of the formula or phenylketonurics;
- Endocrinological or rheumatic diseases;
- Patient with recent initiation of vigorous physical exercise or exercise routine for weight loss and/or;
- Liver or kidney failure by clinical and/or laboratory criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Food Supplement with Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients in the Outpatient Clinic of the New Juan I. Menchaca Civil Hospital
Clinical trial, randomized, double-blind, controlled with a placebo group, 40 patients between 18 and 60 years of age, with the presence of overweight, will be divided into parallel groups, group A cocoa, amaranth seed and ginger, group B cocoa, group C amaranth, group D placebo, with the objective of evaluating the effect of the nutritional supplement in overweight or obese patients on cytokines, insulin resistance and oxidative stress. The study consists of 4 visits: screening (-21 days), baseline (day 0), follow-up (week 6) and end of the study (12 weeks) and 2 follow-up calls (weeks 3 and 10). For 12 weeks they will take one sachet of the supplement containing cocoa, amaranth seed and ginger or placebo daily. Waist circumference, somatometric parameters, vital signs, nocturnal decrease in blood pressure, ankle arm index, cytokines, glucose, glycated hemoglobin, hs-CRP, lipid profile, insulin, antioxidant effect, blood cytometry, function tests will be evaluated. liver, urea, creatinine, uric acid and urine pregnancy test for women of childbearing age. A 24-hour reminder and frequency of consumption will be carried out to assess the diet at each of the visits and nutritional recommendations will be given. Adherence to treatment (Morisky-Green), adverse events and concomitant treatments will be verified throughout the study.
Read the detailed description
Overweight and obesity are a public health problem with worldwide prevalence and play an important role in the emergence of chronic diseases. Overweight is characterized by low-grade chronic inflammation and is associated with an abnormal inflammatory response, oxidative stress and low sensitivity. to insulin. Inflammation of adipose tissue is initiated and sustained over time by dysfunctional adipocytes that secrete inflammatory adipokines; elevated proinflammatory stimuli directly affect insulin signaling in target tissues. Oxidative stress alters mitochondrial activity, modifies the concentration of inflammation levels associated with many adipocytes, promotes lipogenesis, stimulates the change of preadipocytes for mature adipocytes and regulates the energy balance in neurons that control appetite. It is also an important regulator. of insulin sensitivity.
The solution to the consequences of obesity and overweight, low-grade inflammation, oxidative stress and insulin sensitivity are based on pharmaceutical treatments and surgical processes, but changes in lifestyle are the cornerstone of treatment, however the patient's adherence to treatment is low and the results are long-term, for this reason some authors have dedicated themselves to looking for alternatives that complement changes in lifestyle and improve health status.
Polyphenols are bioactive compounds that have been shown to influence insulin resistance, oxidative stress and inflammation. There is extensive evidence from clinical studies and meta-analyses in overweight patients to support the effects of this study's supplement on waist circumference, weight, BMI, blood pressure, insulin sensitivity, markers of inflammation, and oxidative stress.
Cocoa has been positioned as a preventive phytopharmaceutical due to its polyphenolic compounds, mainly flavonols with anti-inflammatory and antioxidant effects, which can help prevent or delay the complications of DM2 by modulating insulin secretion.
Amaranth seed is a source of protein, calcium, iron, dietary fiber, vitamin E and D, with a high content of monounsaturated fats and polyunsaturated fatty acids such as squalene, which have been given anti-inflammatory and antioxidant properties, Mozak and collaborators in 2018 did a clinical trial with amaranth seed in overweight patients with favorable results in reducing fasting insulin and the HOMA-IR index.
Ginger has been widely studied due to its potential in reducing glucose, lipid and body fat levels, and has been used as a preventative in chronic diseases. A clinical trial conducted in 2019 by Rahimlou and collaborators included 37 participants with metabolic syndrome, significantly decreased fasting glucose levels and improved insulin resistance.
The objective of the present study is to evaluate the effect of a supplement with cocoa, amaranth seed and ginger in overweight patients on inflammation, insulin resistance and oxidative stress.
- Being tested
- Cocoa, amaranth seed and ginger, Amaranth seed, Cocoa, Placebo
- Keywords
- Food supplement, Cocoa, Amaranth seed, Ginger, Oxidative stress, Inflammation
- Medical subject headings
- Obesity, Overweight, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa, amaranth seed and gingerDietary supplement
Also called cocoa, ginger, amaranth seed
Sachet with 20gr of cocoa, 10g of amaranth seed and 1g of ginger, one dose per day for 12 weeks
Amaranth seedDietary supplement
Sachet with 10g of amaranth seed one dose per day for 12 weeks
CocoaDietary supplement
Sachet with 20gr of cocoa one dose per day for 12 weeks
PlaceboDietary supplement
Sachet with coloring and flavoring, one dose per day for 12 weeks one dose per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Food supplement: cocoa, amaranth seed and ginger | Active comparator | Group A:
20g Cocoa, 10g amaranth seed and 1g ginger once a day for 12 weeks Receives: Dietary Supplement: Cocoa, amaranth seed and ginger |
| Food supplement: cocoa | Active comparator | Group B:
20g Cocoa once a day for 12 weeks Receives: Dietary Supplement: Cocoa |
| Food supplement: amaranth | Active comparator | Group C:
10g Amaranth seed once a day for 12 weeks Receives: Dietary Supplement: Amaranth seed |
| Food supplement: placebo | Placebo comparator | Group D:
Coloring and flavoring, one dose per day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Insulin Resistance (IR) at 3 months
Average baseline and final HOMA-IR index
Measured: Change from baseline visit to final 3 months
Change from baseline in oxidative stress markers Superoxide Dismutase (SOD), Catalase (CAT) and Glutathione Peroxidase (GPX)
Basal and final average of SOD, CAT and GPX
Measured: Change from baseline visit to final 3 months
Secondary outcomes (4)
Change in metabolic variables (Weight, kg) (Height, m) (Body Mass Index BMI)
Average baseline and final visit (Weight, kg) (Height, m) in combination for BMI (Body Mass Index, kg/m2)
Measured: Change from baseline visit to final 3-month period
Change in metabolic variables (Waist Circumference WC, cm)
Average baseline and final visit (Waist Circumference WC, cm)
Measured: Change from baseline visit to final 3-month period
Change in metabolic variables (% fat, % visceral fat)
Average baseline and final visit (% fat, % visceral fat)
Measured: Change from baseline visit to final 3-month period
Change in metabolic variables (Muscle Mass MM, kg)
Average baseline and final visit (Muscle Mass MM, kg)
Measured: Change from baseline visit to final 3-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start20 Aug 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial, randomized, double-blind, controlled with a placebo group, 40 patients between 18 and 60 years of age, with the presence of overweight, will be divided into parallel groups, group A cocoa, amaranth seed and ginger, group B cocoa, group C amaranth, group D placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Miguel Román Pintos, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769035
- Sponsor's protocol ID
- 00082
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Food Supplement with Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients in the Outpatient Clinic of the New Juan I. Menchaca Civil Hospital
- ClinicalTrials.gov ID
- NCT06769035
- Acronym / sponsor ID
- 00082
- Keywords
- Food supplement, Cocoa, Amaranth seed, Ginger, Oxidative stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Jan 2025 (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.
Clinical trial, randomized, double-blind, controlled with a placebo group, 40 patients between 18 and 60 years of age, with the presence of overweight, will be divided into parallel groups, group A cocoa, amaranth seed and ginger, group B cocoa, group C amaranth, group D placebo, with the objective of evaluating the effect of the nutritional supplement in overweight or obese patients on cytokines, insulin resistance and oxidative stress. The study consists of 4 visits: screening (-21 days), baseline (day 0), follow-up (week 6) and end of the study (12 weeks) and 2 follow-up calls (weeks 3 and 10). For 12 weeks they will take one sachet of the supplement containing cocoa, amaranth seed and ginger or placebo daily. Waist circumference, somatometric parameters, vital signs, nocturnal decrease in blood pressure, ankle arm index, cytokines, glucose, glycated hemoglobin, hs-CRP, lipid profile, insulin, antioxidant effect, blood cytometry, function tests will be evaluated. liver, urea, creatinine, uric acid and urine pregnancy test for women of childbearing age. A 24-hour reminder and frequency of consumption will be carried out to assess the diet at each of the visits and nutritional recommendations will be given. Adherence to treatment (Morisky-Green), adverse events and concomitant treatments will be verified throughout the study.
Detailed description
Overweight and obesity are a public health problem with worldwide prevalence and play an important role in the emergence of chronic diseases. Overweight is characterized by low-grade chronic inflammation and is associated with an abnormal inflammatory response, oxidative stress and low sensitivity. to insulin. Inflammation of adipose tissue is initiated and sustained over time by dysfunctional adipocytes that secrete inflammatory adipokines; elevated proinflammatory stimuli directly affect insulin signaling in target tissues. Oxidative stress alters mitochondrial activity, modifies the concentration of inflammation levels associated with many adipocytes, promotes lipogenesis, stimulates the change of preadipocytes for mature adipocytes and regulates the energy balance in neurons that control appetite. It is also an important regulator. of insulin sensitivity.
The solution to the consequences of obesity and overweight, low-grade inflammation, oxidative stress and insulin sensitivity are based on pharmaceutical treatments and surgical processes, but changes in lifestyle are the cornerstone of treatment, however the patient's adherence to treatment is low and the results are long-term, for this reason some authors have dedicated themselves to looking for alternatives that complement changes in lifestyle and improve health status.
Polyphenols are bioactive compounds that have been shown to influence insulin resistance, oxidative stress and inflammation. There is extensive evidence from clinical studies and meta-analyses in overweight patients to support the effects of this study's supplement on waist circumference, weight, BMI, blood pressure, insulin sensitivity, markers of inflammation, and oxidative stress.
Cocoa has been positioned as a preventive phytopharmaceutical due to its polyphenolic compounds, mainly flavonols with anti-inflammatory and antioxidant effects, which can help prevent or delay the complications of DM2 by modulating insulin secretion.
Amaranth seed is a source of protein, calcium, iron, dietary fiber, vitamin E and D, with a high content of monounsaturated fats and polyunsaturated fatty acids such as squalene, which have been given anti-inflammatory and antioxidant properties, Mozak and collaborators in 2018 did a clinical trial with amaranth seed in overweight patients with favorable results in reducing fasting insulin and the HOMA-IR index.
Ginger has been widely studied due to its potential in reducing glucose, lipid and body fat levels, and has been used as a preventative in chronic diseases. A clinical trial conducted in 2019 by Rahimlou and collaborators included 37 participants with metabolic syndrome, significantly decreased fasting glucose levels and improved insulin resistance.
The objective of the present study is to evaluate the effect of a supplement with cocoa, amaranth seed and ginger in overweight patients on inflammation, insulin resistance and oxidative stress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Clinical trial, randomized, double-blind, controlled with a placebo group, 40 patients between 18 and 60 years of age, with the presence of overweight, will be divided into parallel groups, group A cocoa, amaranth seed and ginger, group B cocoa, group C amaranth, group D placebo
| Arm | Type | Receives |
|---|---|---|
| Food supplement: cocoa, amaranth seed and ginger | Active comparator | Dietary Supplement: Cocoa, amaranth seed and gingerGroup A: 20g Cocoa, 10g amaranth seed and 1g ginger once a day for 12 weeks |
| Food supplement: cocoa | Active comparator | Dietary Supplement: CocoaGroup B: 20g Cocoa once a day for 12 weeks |
| Food supplement: amaranth | Active comparator | Dietary Supplement: Amaranth seedGroup C: 10g Amaranth seed once a day for 12 weeks |
| Food supplement: placebo | Placebo comparator | Dietary Supplement: PlaceboGroup D: Coloring and flavoring, one dose per day for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed informed consent;
- Men or women;
- Age between 18 and 60 years;
- Waist circumference ≥ 88 cm in women or ≥ 94 cm in men;
- Plus one of the following criteria:
Key exclusion criteria (11 listed)
- On pharmacological treatment or diet for weight control;
- Routine use of antioxidants in the last 3 months;
- BMI ≥ 30 kg/m2 or recent bariatric surgery (< 6 months);
- LDL cholesterol > 160 mg/dL or total cholesterol > 200 mg/dL, and no treatment for dyslipidemia;
- Major micro or macrovascular complications due to severe metabolic disease (history of acute coronary syndrome, cerebrovascular disease, peripheral arterial insufficiency or aortic aneurysm);
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 |
|---|---|---|
| Cocoa, amaranth seed and gingerAlso: cocoa, ginger, amaranth seedSachet with 20gr of cocoa, 10g of amaranth seed and 1g of ginger, one dose per day for 12 weeks | Dietary supplement | Food supplement: cocoa, amaranth seed and ginger |
| Amaranth seedSachet with 10g of amaranth seed one dose per day for 12 weeks | Dietary supplement | Food supplement: amaranth |
| CocoaSachet with 20gr of cocoa one dose per day for 12 weeks | Dietary supplement | Food supplement: cocoa |
| PlaceboSachet with coloring and flavoring, one dose per day for 12 weeks one dose per day for 12 weeks | Dietary supplement | Food supplement: placebo |
Primary outcome
Change from baseline in Insulin Resistance (IR) at 3 months
Time frame: Change from baseline visit to final 3 months
Average baseline and final HOMA-IR index
Change from baseline in oxidative stress markers Superoxide Dismutase (SOD), Catalase (CAT) and Glutathione Peroxidase (GPX)
Time frame: Change from baseline visit to final 3 months
Basal and final average of SOD, CAT and GPX
4 secondary outcomes
Change in metabolic variables (Weight, kg) (Height, m) (Body Mass Index BMI)
Time frame: Change from baseline visit to final 3-month period
Change in metabolic variables (Waist Circumference WC, cm)
Time frame: Change from baseline visit to final 3-month period
Change in metabolic variables (% fat, % visceral fat)
Time frame: Change from baseline visit to final 3-month period
Change in metabolic variables (Muscle Mass MM, kg)
Time frame: Change from baseline visit to final 3-month period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa, amaranth seed and ginger, Amaranth seed and Cocoa in people with Oxidative Stress and Inflammation Biomarkers, run by University of Guadalajara at 1 site in Mexico.
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 9 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
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 in Insulin Resistance (IR) at 3 months (time frame: Change from baseline visit to final 3 months). The study lists 2 primary outcomes in all. 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 10 Jan 2025.