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A study on healthy people to see the effect on blood glucose levels after eating a high sugar food with fiber and to see the effect of fiber on hunger.

A clinical study to determine the blood glucose response of a dietary fiber on high Glycemic index food and satiety response of a dietary fiber in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/07/006013
Enrollment
32
Registered
2015-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Dietary fiber: It is a sachet of 5gms. It will be given to healthy volunteers only once on 2 days (Day 3 and Day 5). Control Intervention1: Glucose or White bread: either 50 grams of gl

Sponsors

Mr Ajay Nilawar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males or females in the age 18- 65 years (both inclusive). 2. Be of normal health as determined by the investigator from medical history, clinical and physical examination. 3. Random blood sugar level 4. BMI between 18.5 to 27 kg/m2 (both inclusive). 5. Must be willing to or likely to comply with all study requirements. 6. Must be able and willing to provide written informed consent. 7. Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.

Exclusion criteria

Exclusion criteria: 1. Previous history of any clinically significant medical condition e.g. cardiovascular, type 2 diabetes mellitus, eating disorder or serious gastrointestinal indications which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation. 2. Suffering from any condition which may interfere with nutrient absorption, distribution, metabolism and excretion in opinion of the Investigator e.g. subacute obstruction. 3. Current use of medication which may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation in opinion of the Investigator. 4. Abuse of drugs or alcohol. 5. Known case of sensitivity to Gluten or Coeliac disease. 6. Pregnant or lactating women. 7. Currently participating or had participated in any other interventional study in last 1 month prior to screening. 8. Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, illiterate, inability to attend study visits required by the protocol).

Design outcomes

Primary

MeasureTime frame
1. Blood glucose response of the fiber 2. Change in satiety using visual analogue scaleTimepoint: 1. Blood glucose response of the fiber 180 min post administration of fiber. 2. Satiety response at 0 minutes, 15 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hours.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Almas Pathan

Jehangir Clinical Development Centre Pvt Ltd

almas.jikare@rediffmail.com9763002830

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026