| CTRI Number |
CTRI/2025/12/098550 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Behavioral
Nutraceutical
Other (Specify) [FOOD SUPPLEMENT (AMARANTHUS)] |
| Study Design |
Other |
|
Public Title of Study
|
Does eating Amaranthus improve hormone health in women going through menopause? |
|
Scientific Title of Study
|
Analysing the efficacy of Amaranthus in modulating metabolic hormones and reproductive hormones and their health-related behavioural changes in perimenopausal and postmenopausal women. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Charu Gupta |
| Designation |
Ph.D Student |
| Affiliation |
|
| Address |
b-1901 bridgewood apartment hiranandani eggatur siruseri omr chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
09790771553 |
| Fax |
|
| Email |
u022401192@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. N. Preetha |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Clinical Nutrition, Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai- 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
98409 80947 |
| Fax |
|
| Email |
preetha.n@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Charu Gupta |
| Designation |
Ph.D Student |
| Affiliation |
|
| Address |
b-1901 bridgewood apartment hiranandani eggatur siruseri omr chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
09790771553 |
| Fax |
|
| Email |
u022401192@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR, CHENNAI- 600116 |
|
|
Primary Sponsor
|
| Name |
charu gupta |
| Address |
b-1901 bridgewood apartment hiranandani eggatur siruseri omr chennai
|
| Type of Sponsor |
Other [UGC NET JRF stipend] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Preetha |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
SRI RAMACHANDRA INSTITUE OF HIGHER EDUCATION AND RESEARCH (DU) NO-1 RAMACHANDRA NAGAR, PORUR, CHENNAI - 600116
Chennai
TAMIL NADU |
09790771553
u022401192@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMACHANRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DEEMED TO BE UNIVERSITY)- INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amaranthus-Based Functional Food Supplementation |
Participants in the intervention arm will receive a daily supplementation of a standardized functional food product developed using Amaranthus cruentus. The formulation is prepared from 30 g of amaranth seeds/grains and 20 g of red and green amaranth leaves, developed and standardized through laboratory analyses (proximate composition, amino acid profiling, phytochemical characterization, sensory evaluation and shelf-life testing).
The supplement will be provided once daily for 16 weeks (4 months). Participants will consume the product in the standardized recipe developed during product formulation (e.g., porridge/curd/flavoured milk-based incorporation). Supplement adherence will be monitored through weekly telephonic follow-up and monthly in-person checks.
The intervention aims to evaluate the effect of amaranth supplementation on:
Metabolic hormones: insulin, leptin, ghrelin, adiponectin, cortisol
Reproductive hormones: estrogen, progesterone, FSH, LH
Anthropometric indicators: BMI, waist circumference, waist–hip ratio
Dietary intake and sleep quality: using 3-day diet recall and Pittsburgh Sleep Quality Index (PSQI)
Health-related behavioural changes: using a validated menopause questionnaire
Blood samples, anthropometry, dietary assessment, and sleep quality assessments will be collected at baseline and post-intervention.
The control group will receive no supplementation and will continue their routine diet and lifestyle without any added intervention. |
| Comparator Agent |
Standard Diet (No Amaranth Supplementation) |
Participants in the control group will continue with their usual habitual diet without any amaranth-based supplementation. They will receive no placebo, as this is a quasi-experimental study design without randomization.
Both groups (control and intervention) will undergo the same assessment schedule at baseline and after 16 weeks, including anthropometry, diet recall, sleep quality (PSQI), and hormonal profile.
Purpose of Comparator:
To evaluate differences in outcomes between women receiving the amaranth-based functional food and those maintaining their regular diet without supplementation. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
a. To include women aged between 40–65 years and having a BMI between 18.5 – 40 kg/m².
b. To include those women who are willing to follow-up for a minimum of 6 months.
|
|
| ExclusionCriteria |
| Details |
a. To exclude women who have a history of metabolic disorders such as cardiovascular, Type 2 diabetes mellitus, renal and liver disorders.
b. To exclude women who are smoking, alcohol, or drug.
c. To exclude women who are using hormonal supplements, steroids, anti-obesity medications, or sleep medications.
d. To exclude women using hormone replacement therapy (HRT) or with hysterectomy, Thyroid dysfunction (Hypothyroidism) will be excluded unless vasomotor symptoms are present.
e. To exclude women who have a history of complete absence of menstruation for more than 5 to 10 years.
f. To exclude women who are known to have an allergy to certain grains or seeds.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
anthropometric measurements - • Height and weight measured, BMI, • Waist circumference (WC) and hip circumference (HC) measured • Metabolic Hormones: Insulin, leptin, ghrelin, cortisol, adiponectin
• Reproductive Hormones: Estrogen, progesterone, FSH, LH.
Questionnaires - Pittsburg sleep quality index, Menopause-health related behaviourial changes
|
Pre-intervention and post-intervention evaluations, with the final assessment done after 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the efficacy of Amaranthus (Amaranthus cruentus) as a functional food intervention to modulate metabolic and reproductive hormones and improve health-related behaviours, including sleep quality, in peri- and postmenopausal women. Menopause is associated with hormonal imbalance, visceral adiposity, metabolic dysfunction, vasomotor symptoms, mood disturbances, and sleep disruption. While Hormone Replacement Therapy (HRT) is commonly used, its long-term risks and cost limit acceptability. Amaranth, a nutrient-dense pseudocereal rich in essential amino acids, minerals, antioxidants, and bioactive phytochemicals, may offer a safe and cost-effective dietary alternative to support hormonal regulation and metabolic health. This quasi-experimental study will include 128 women aged 40–65 years, screened and categorized into perimenopausal and postmenopausal groups based on menstrual history and FSH levels. Participants in each stage will be divided into intervention and control groups. A newly developed amaranth-based functional food product will be supplemented to the intervention group for 16 weeks. Pre- and post-intervention assessments will measure anthropometry, dietary intake, metabolic hormones (insulin, leptin, ghrelin, adiponectin, cortisol), reproductive hormones (estrogen, progesterone, FSH, LH), and sleep quality using the Pittsburgh Sleep Quality Index (PSQI). Compliance will be monitored. Product development includes nutrient profiling, phytochemical analysis (HPLC, GC–MS), sensory evaluation, and shelf-life testing. The study will determine whether daily amaranth supplementation improves hormonal balance and associated health behaviours in peri- and postmenopausal women, providing evidence for a natural, affordable, and culturally acceptable alternative or adjunct to HRT. |