PreDiabetesAlguesNCT03075943
Brown Seaweed Extract on Glycemic Control and Body Weight
A study testing InSea2 in people with PreDiabetes and Insulin Resistance, run by Laval University at 1 site in Canada.
Trial summary
The overall goal of this study is to investigate the effects of a daily dietary supplement of brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion in overweight prediabetic men and women in association with a moderate weight loss intervention. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Insulin Resistance
- What is being tested?
- InSea2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2016to 31 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight (BMI > 25; waist circumference ≥ 80cm for women and ≥ 94 cm for men)
- fasting insulin (≥ 60 pmol/L)
- Impaired fasting glycemia with or without impaired glucose tolerance
- HbA1c between 5.6 and 6.4
- non-smoking
- stable weight in the past 3 months
Who cannot join
- diabetes
- chronic disease (thyroid dysfunction, hepatic or gastrointestinal disorder, uncontrolled hypertension)
- taking drugs that could affect glucose or lipid metabolism or weight and appetite
- taking dietary supplements (protein powders, fish oil, omega-3 or any marine supplements) or natural health products that could affect glucose, lipid, weight or appetite
- major surgery 3 months prior to the study
- pregnancy
- fish, seafood or iodine allergy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutrition and Functional Foods (INAF), Laval University
Québec, G1V 0A6
About this study
Official title: Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.
The overall goal of this study is to investigate the effects of a daily dietary supplement of brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion in overweight prediabetic men and women in association with a moderate weight loss intervention.
Read the detailed description
Diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular risk. They may also facilitate weight control by promoting satiety, insulin sensitivity and optimal insulin secretion after a meal. Food ingredients may indeed reduce postprandial glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity that may slow down the absorption of carbohydrates. InSea2® is a unique combination of polyphenolic extracts of brown algae (Ascophyllum nodosum and Fucus vesiculosus) which has been shown to inhibit the action of α-amylase and α-glucosidase. Preliminary data in healthy men and women have demonstrated a reducing effect on plasma insulin of a single intake of InSea2® consumed with a high-carbohydrate meal.
The main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2 capsules) of brown algae extract powder (InSea2®) on body weight and blood glucose homeostasis (glucose, insulin, c-peptide) measured in the fasting state and during a 2-hour oral glucose tolerance test (OGTT) in overweight prediabetic men and women.
The secondary objectives are to assess the contribution of a daily consumption of this supplement (InSea2®) on weight loss when associated with a daily caloric restriction of 500 kcal due to individualized nutritional intervention on markers of lipid profile, blood pressure, inflammation, oxidative stress and gut barrier integrity.
The investigators expect that InSea2® lowers body weight and blood glucose homeostasis (glucose, insulin or C-peptide, as marker of insulin secretion, in the fasting state or during a 2-hour oral glucose tolerance test) in association with metabolic and inflammatory markers in the context of moderate weight loss in overweight prediabetic human subjects.
- Conditions
- PreDiabetes, Insulin Resistance
- Being tested
- InSea2, Placebo
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InSea2Dietary supplement
Also called Brown seaweed extract supplement
Daily supplement: 2 capsules of InSea2
PlaceboDietary supplement
Also called Control
Daily supplement: 2 capsules of Placebo
| Study group | Role | What they receive |
|---|---|---|
| InSea2 | Experimental | 2 capsules/day of InSea2 administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal) Receives: Dietary Supplement: InSea2 |
| Placebo | Placebo comparator | 2 capsules/day of Placebo administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood glucose (mmol/L)
glucose in the fasting state and during a 2h-OGTT
Measured: at baseline and at the end of the intervention (12 week)
Changes in blood insulin (pmol/L) and C-peptide (pmol/L)
insulin and C-peptide in the fasting state and during a 2h-OGTT
Measured: at baseline and at the end of the intervention (12 week)
Changes in anthropometrics
body weight (kg), lean mass (kg) and fat mass (kg)
Measured: at baseline and at the end of the intervention (12 week)
Secondary outcomes (7)
Changes in blood pressure
Systolic and diastolic blood pressure (mmHg)
Measured: at baseline and at the end of the intervention (12 week)
Changes in heart rate
Heart rate (n/min)
Measured: at baseline and at the end of the intervention (12 week)
Changes in lipid profile
cholesterol (mmol/L), triglycerides (mmol/L), LDLc (mmol/L), HDLc (mmol/L)
Measured: at baseline and at the end of the intervention (12 week)
Changes in hsCRP
HsCRP (mg/L)
Measured: at baseline and at the end of the intervention (12 week)
Changes in Il-6
IL-6 (pg/L)
Measured: at baseline and at the end of the intervention (12 week)
Changes in marker of oxidative stress
F2-isoprostane (ng/mL)
Measured: at baseline and at the end of the intervention (12 week)
Changes in markers of gut barrier integrity
LBP (ng/mL), zonulin (ng/mL)
Measured: at baseline and at the end of the intervention (12 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startDec 2016
- Primary completionJul 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, innoVactiv Inc.
- Responsible party
- Principal investigator, Helene Jacques, Laval University
- Investigators
- Hélène Jacques, PhD, Principal investigator, Institue of Nutrition and Functional Food (INAF), Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075943
- Sponsor's protocol ID
- ALGUES 2016-227
- Acronym
- Algues
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2017
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.
- ClinicalTrials.gov ID
- NCT03075943
- Acronym / sponsor ID
- Algues / ALGUES 2016-227
- Conditions
- PreDiabetes, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, innoVactiv Inc.
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Mar 2017 (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 overall goal of this study is to investigate the effects of a daily dietary supplement of brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion in overweight prediabetic men and women in association with a moderate weight loss intervention.
Detailed description
Diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular risk. They may also facilitate weight control by promoting satiety, insulin sensitivity and optimal insulin secretion after a meal. Food ingredients may indeed reduce postprandial glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity that may slow down the absorption of carbohydrates. InSea2® is a unique combination of polyphenolic extracts of brown algae (Ascophyllum nodosum and Fucus vesiculosus) which has been shown to inhibit the action of α-amylase and α-glucosidase. Preliminary data in healthy men and women have demonstrated a reducing effect on plasma insulin of a single intake of InSea2® consumed with a high-carbohydrate meal.
The main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2 capsules) of brown algae extract powder (InSea2®) on body weight and blood glucose homeostasis (glucose, insulin, c-peptide) measured in the fasting state and during a 2-hour oral glucose tolerance test (OGTT) in overweight prediabetic men and women.
The secondary objectives are to assess the contribution of a daily consumption of this supplement (InSea2®) on weight loss when associated with a daily caloric restriction of 500 kcal due to individualized nutritional intervention on markers of lipid profile, blood pressure, inflammation, oxidative stress and gut barrier integrity.
The investigators expect that InSea2® lowers body weight and blood glucose homeostasis (glucose, insulin or C-peptide, as marker of insulin secretion, in the fasting state or during a 2-hour oral glucose tolerance test) in association with metabolic and inflammatory markers in the context of moderate weight loss in overweight prediabetic human subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InSea2 | Experimental | Dietary Supplement: InSea22 capsules/day of InSea2 administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules/day of Placebo administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- overweight (BMI > 25; waist circumference ≥ 80cm for women and ≥ 94 cm for men)
- fasting insulin (≥ 60 pmol/L)
- Impaired fasting glycemia with or without impaired glucose tolerance
- HbA1c between 5.6 and 6.4
- non-smoking
Key exclusion criteria (7 listed)
- diabetes
- chronic disease (thyroid dysfunction, hepatic or gastrointestinal disorder, uncontrolled hypertension)
- taking drugs that could affect glucose or lipid metabolism or weight and appetite
- taking dietary supplements (protein powders, fish oil, omega-3 or any marine supplements) or natural health products that could affect glucose, lipid, weight or appetite
- major surgery 3 months prior to the study
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 |
|---|---|---|
| InSea2Also: Brown seaweed extract supplementDaily supplement: 2 capsules of InSea2 | Dietary supplement | InSea2 |
| PlaceboAlso: ControlDaily supplement: 2 capsules of Placebo | Dietary supplement | Placebo |
Primary outcome
Changes in blood glucose (mmol/L)
Time frame: at baseline and at the end of the intervention (12 week)
glucose in the fasting state and during a 2h-OGTT
Changes in blood insulin (pmol/L) and C-peptide (pmol/L)
Time frame: at baseline and at the end of the intervention (12 week)
insulin and C-peptide in the fasting state and during a 2h-OGTT
Changes in anthropometrics
Time frame: at baseline and at the end of the intervention (12 week)
body weight (kg), lean mass (kg) and fat mass (kg)
7 secondary outcomes
Changes in blood pressure
Time frame: at baseline and at the end of the intervention (12 week)
Changes in heart rate
Time frame: at baseline and at the end of the intervention (12 week)
Changes in lipid profile
Time frame: at baseline and at the end of the intervention (12 week)
Changes in hsCRP
Time frame: at baseline and at the end of the intervention (12 week)
Changes in Il-6
Time frame: at baseline and at the end of the intervention (12 week)
Changes in marker of oxidative stress
Time frame: at baseline and at the end of the intervention (12 week)
Changes in markers of gut barrier integrity
Time frame: at baseline and at the end of the intervention (12 week)
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 16 Aug 2022.
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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.
Hélène Jacques, PhD principal investigator
Institue of Nutrition and Functional Food (INAF), Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InSea2 in people with PreDiabetes and Insulin Resistance, run by Laval University at 1 site in Canada.
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 6 inclusion and 7 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 16 Aug 2022. 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 Canada. 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?
Changes in blood glucose (mmol/L) (time frame: at baseline and at the end of the intervention (12 week)). The study lists 3 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 16 Aug 2022.